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36 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Estybon (rigosertib) / Traws Pharma, SymBio Pharma, Knight Therap
2016-003832-19: Clinical Trial to evaluate the efficacy of the drug "Rigosertib" against non- melanoma skin cancer in "Butterfly Children". Klinische Studie um die Wirksamkeit des Medikaments Rigosertib gegen weißen Hautkrebs bei "Schmetterlingskindern" zu bewerten

Ongoing
2
12
Europe
Rigosertib, ON 01910.Na, Capsule, soft, Concentrate for solution for infusion, Concentrate for oral solution
Gemeinn. Salzburger Landeskliniken BetriebsGesmbH, University Hospital for Dermatology, EB-House Austria, DEBRA International
Recessive dystrophic epidermolysis bullosa (RDEB) is a severe genodermatose caused by mutations in COL7A1, characterized by generalized skin blistering and involvement of mucous membranes. Aggressive metastasizing squamous cell carcinomas (SCCs) are a common complication, which reduce patients’ average life expectancy to less than 40 years. The aim of this study is to evaluate anti-tumor activity of oral Rigosertib, a PLK1 inhibitor, in RDEB patients diagnosed with SCCs. Rezessiv dystrophe Epidermolysis bullosa (RDEB) ist eine Genodermatose, die durch COL7A1 Mutationen entsteht und durch generalisierte Blasenbildung und Beteiligung von Schleimhäuten charakterisiert ist. Die Patienten leiden an chronischen Wunden in denen sich oft agressive methastasierend Plattenepithelkarzinome bilden, die die Lebenserwartung auf unter 40 Jahre senken. Ziel der Studie ist die Anti-Tumor Wirkung von oralem Rigosertib in RDEB- Patienten mit Plattenepithelkarzinomen zu bewerten., Metastasizing non-melanoma skin cancer is a severe complication of recessive dystrophic epidermolysis bullosa. A new drug against this form of cancer shall be tested in this trial. Eine schwerwiegende Komplikationen von rezessiv dystropher Epidermolysis bullosa ist metastasierender weißer Hautkrebs. In der Studie soll ein neues Medikament gegen diesen Krebs getestet werden, Diseases [C] - Cancer [C04]
 
 
NCT05764395: Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors

Suspended
2
29
US
Rigosertib, Pembrolizumab, Magnetic Resonance Imaging, Biospecimen Collection, Biopsy
Vanderbilt-Ingram Cancer Center
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Refractory Melanoma, Unresectable Melanoma
05/28
05/29
NCT04263090: Rigosertib Plus Nivolumab for KRAS+ NSCLC Patients Who Progressed on First-Line Treatment

Checkmark Presentation of P1/2 data in combination with nivolumab for treatment of advanced KRAS+ NSCLC
Sep 2022 - Sep 2022: Presentation of P1/2 data in combination with nivolumab for treatment of advanced KRAS+ NSCLC
Checkmark Data from trial in combination with nivolumab in progressive K-RAS mutated NSCLC
Sep 2021 - Sep 2021: Data from trial in combination with nivolumab in progressive K-RAS mutated NSCLC
Completed
1/2
25
US
Rigosertib, Nivolumab
Icahn School of Medicine at Mount Sinai, Bristol-Myers Squibb, Traws Pharma, Inc.
Non-small Cell Lung Cancer, Adenocarcinoma, Stage IV
12/23
12/23
NCT03786237: Rigosertib for RDEB-SCC

Recruiting
1/2
12
Europe
Rigosertib Oral Capsules / Rigosertib Intravenous
Prof. Johann Bauer
Epidermolysis Bullosa Dystrophica, Squamous Cell Carcinoma
12/25
06/26
NCT04177498: Rigosertib in Patients With Recessive Dystrophic Epidermolysis Bullosa Associated SCC

Active, not recruiting
1
6
US
Rigosertib Sodium, ON 01910.Na, Quality-of-Life Assessment, Quality of Life Assessment
Thomas Jefferson University, Traws Pharma, Inc.
Recessive Dystrophic Epidermolysis Bullosa
05/25
06/25
Orladeyo (berotralstat) / BioCryst
APeX-P, NCT05453968 / 2021-005932-50: Berotralstat Treatment in Children With Hereditary Angioedema

Active, not recruiting
3
29
Europe, Canada, RoW
Berotralstat, BCX7353, Orladeyo®
BioCryst Pharmaceuticals
Hereditary Angioedema, Pediatric
09/24
02/27
APeX-A, NCT04933721 / 2020-004230-37: Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies

Active, not recruiting
3
139
Europe, RoW
berotralstat, Orladeyo
BioCryst Pharmaceuticals
Hereditary Angioedema, HAE
08/31
08/31
2015-003923-74: A placebo controlled trial of of three doses of BCX7353 to evaluate the safety and efficacy in the prevention of attacks in patients with HAE

Ongoing
2
24
Europe
BC7353, BCX7353, Capsule, hard
BioCryst Pharmaceuticals Inc, BioCryst Pharmaceutical Inc
Hereditary Angioedema, Hereditary Angioedema, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
Besremi (ropeginterferon alfa-2b-njft) / PharmaEssentia
PARADIGM-PV, NCT06290765: Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera

Not yet recruiting
4
70
NA
Ropeginterferon alfa-2b, P1101, Phlebotomy and aspirin, Phlebotomy and aspirin plus the other cytoreductive agents
PharmaEssentia
Polycythemia Vera, Myeloproliferative Neoplasm
12/26
06/27
ENDURE-CML-IX, NCT03117816 / 2016-001030-94: ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission

Completed
3
214
Europe
AOP2014 / Pegylated-Proline-interferon alpha-2b, Surveillance
Philipps University Marburg Medical Center, Deutsche Krebshilfe e.V., Bonn (Germany), AOP Orphan Pharmaceuticals AG
Chronic Myeloid Leukemia in Remission
01/22
12/22
ChiCTR2000036395: A Phase 3, Open-Label, Multicenter, Randomized, Active-Controlled Study to Assess Pharmacokinetics and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as Second Line Therapy for Essential Thrombocythemia

Not yet recruiting
3
160
 
Subcutaneous injection of drug P1101 ;Take anaglyl orally
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences; PharmaEssentia Corporation, PharmaEssentia Corporation
Essential Thrombocythemia
 
 
SURPASS ET, NCT04285086: Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance

Hourglass Oct 2024 - Dec 2024 : Data for 2L essential thrombocythemia
Active, not recruiting
3
174
Canada, Japan, US, RoW
Ropeginterferon alfa-2b, P1101, Anagrelide
PharmaEssentia, Medpace, Inc., EPS International, Brightech International
Essential Thrombocythemia
11/24
12/25
ROP-ET, NCT06514807: A Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients

Active, not recruiting
3
117
Europe, RoW
Ropeginterferon alfa-2b (BESREMi®)
AOP Orphan Pharmaceuticals AG
Essential Thrombocythaemia
03/28
03/28
NCT05770466: Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19.

Completed
3
134
RoW
P1101 (Ropeginterferon alfa-2b), SOC
National Taiwan University Hospital
COVID-19
12/22
01/23
ECLIPSE-PV, NCT05481151: A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV

Hourglass Feb 2024 - Dec 2024 : Topline data for adults with PV
Active, not recruiting
3
111
Canada, US
P1101 (Ropeginterferon alfa-2b-njft), Ropeginterferon alfa-2b-njft (P1101)
PharmaEssentia
Polycythemia Vera
12/24
07/25
NCT06002490: A Study to Evaluate P1101 in Japanese PV Patients

Completed
3
21
Japan
P1101, Ropeginterferon alfa-2b, Low-dose aspirin, Low-doaw Acetylsalicylic acid, Phlebotomy
PharmaEssentia Japan K.K.
Polycythemia Vera (PV)
07/24
07/24
NCT04655092: Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients

Recruiting
3
67
Japan
P1101 (Ropeginterferon alfa-2b)
PharmaEssentia Japan K.K.
Polycythemia Vera (PV)
06/26
06/26
NCT06468033: P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk

Not yet recruiting
3
150
NA
Ropeginterferon alfa-2b, P1101, Placebo
PharmaEssentia
Primary Myelofibrosis, Myeloproliferative Neoplasm
03/27
04/28
2016-001030-94: Efficacy and safety of pegylated-proline-interferon alpha 2B (AOP2014) in maintaining deep molecular remissions in patients with chronic myeloid leukemia who discontinue ABL-kinase inhibitory therapy, with post-study follow-up. Randomisierte Phase III Studie zur Untersuchung der Sicherheit und Effektivität einer Therapie mit pegyliertem Prolin-Interferon alpha 2b (AOP2014) in der Erhaltung einer tiefen molekularen Remission bei Patienten mit chronischer myeloischer Leukämie, die die bisherige Standardtherapie nach zwei Wochen absetzen, mit anschließender Nachbeobachtungsphase außerhalb der Studie

Not yet recruiting
2/3
214
Europe
AOP2014, Solution for injection in pre-filled pen, Besremi
Philipps University Marburg, Deutsche Krebshilfe
Chronic myeloid leukemia Die chronische myeloische Leukämie, Chronic myeloid leukemia Die chronische myeloische Leukämie, Diseases [C] - Cancer [C04]
 
 
NCT05808322: Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities

Not yet recruiting
2/3
60
RoW
Ropeginterferon alfa-2b, P1101, SOC
National Taiwan University Hospital
COVID-19
05/24
12/24
2014-001367-13: The study to assess the efficacy and safety of new Interferon alpha-2b formulation in patients with primary myelofibrosis

Ongoing
2
24
Europe
Pegylated proline-interferon alpha- 2b, AOP2014,
Medizinische Universtät Wien, Universitätsklinik für Innere Medizin I, AOP ORPHAN PHARMACEUTICALS AG
Primary Myelofibrosis (grade MF-0 and MF-1) according to the WHO criteria
 
 
2018-001044-54: A study of effect and safety of a new combination of drugs for chronic myeloid leukemia in chronic phase. Bosutinib is the basis treatment and patients will be randomized to receive or not to receive a long-acting low dose of Ropeginterferon. Satunnaistettu, etenevä KML:n ensilinjan lääkehoitotutkimus: Lääkeaineen tehoa ja turvallisuutta mittaava tutkimus, jossa pieniannoksinen ropeginterferoni lisätään bosutinibihoitoon hiljattain diagnosoitua, kroonisessa vaiheessa olevaa kroonista myelooista meukemiaa sairastavilla potilailla.

Not yet recruiting
2
212
Europe
Pegylated proline-interferon alpha 2b, AOP2014, Tablet, Solution for injection in pre-filled pen, Bosulif
St Olavs Hospital -Trondheim University Hospital, Pfizer Norge AS, AOP Orphan Pharmaceuticals AG
Chronic myeloid leukemia at diagnosis-chronich phase Diagnoosivaiheen krooninen myelooinen leukemia, kroonisessa vaiheessa, Chronic myeloid leukemia, a type of blood cancer Krooninen myelooinen leukemia, verisyöpätyyppi, Diseases [C] - Cancer [C04]
 
 
NCT03003325 / 2015-004717-25: The Benefit/Risk Profile of AOP2014 in Low-risk Patients With PV

Completed
2
127
Europe
AOP2014, Pegylated-Proline-Interferon α-2b, P1101, Phlebotomies, blood removing, ASA, Acetylsalicylic Acid
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS, AOP Orphan Pharmaceuticals AG
Polycythemia Vera
03/22
03/23
NCT05485948: A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU

Active, not recruiting
2
49
RoW
Ropeginterferon alfa-2b, BESREMI
PharmaEssentia
Polycythemia Vera
09/22
05/25
EXCEED ET, NCT05482971: A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET

Active, not recruiting
2
91
Canada, US
Ropeginterferon alfa-2b-njft (P1101), P1101
PharmaEssentia
Essential Thrombocythemia
03/27
03/27
NCT02370329: P1101 in Treating Patients with Myelofibrosis

Completed
2
11
US
Laboratory Biomarker Analysis, Quality-of-Life Assessment, Quality of Life Assessment, Ropeginterferon Alfa-2B, AOP2014, Besremi, P-1101, P1101, PEG-P-IFN-Alfa-2b, PEG-P-IFN-Alpha-2b, PEG-Proline-Interferon Alfa-2b
Mayo Clinic, National Cancer Institute (NCI)
Primary Myelofibrosis, Secondary Myelofibrosis
11/23
11/23
NCT05731245: Ropeginterferon Alfa 2b for Early MyelofibrosisDIPSS Low/Intermediate-1 Risk Myelofibrosis

Recruiting
2
50
RoW
Ropeginterferon Alfa-2B Prefilled Syringe [Besremi]
National Taiwan University Hospital
Pre-fibrotic Myelofibrosis
10/24
10/26
NCT05467553: A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection

Not yet recruiting
2
30
RoW
Ursodeoxycholic acid, Uroso Tablets, Ropeginterferon alfa-2b, BESREMI, Tenofovir Alafenamide, Vemlidy
National Taiwan University Hospital, PharmaEssentia
Hepatitis D
02/25
08/25
NCT06770842: Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis

Recruiting
2
20
RoW
Ropeginterferon alfa-2b (BESREMi®)
The University of Hong Kong
Primary Myelofibrosis (PMF), Post Polycythemia Myelofibrosis (PPV MF), Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
12/26
12/27
P1101MF, NCT04988815: Ropeginterferon Alfa 2b for Early Myelofibrosis

Recruiting
2
50
RoW
Ropeginterferon alfa-2b
The University of Hong Kong
Primary Myelofibrosis, Prefibrotic Stage, Myelofibrosis
07/25
12/25
NCT04233840: P1101 and Anti-PD1 for After Curative Surgery of Hepatitis B-related Hepatocellular Carcinoma

Recruiting
1/2
72
RoW
P1101 (Ropeginterferon alfa-2b), Nivolumab, Opdivo
National Taiwan University Hospital, PharmaEssentia
Hepatocellular Carcinoma
12/22
07/23
NCT04638439: The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection

Completed
1
20
RoW
P1101 + Nivolumab + Entecavir, P1101 (Ropeginterferon alfa-2b) + Nivolumab + Entecavir
PharmaEssentia
Chronic Hepatitis B Infection, Chronic Hepatitis D Infection
05/25
05/25
NCT07047885: Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)

Recruiting
1
38
US
Ropeginterferon alfa-2b, P1101
H. Lee Moffitt Cancer Center and Research Institute, PharmaEssentia
Cutaneous T Cell Lymphoma
06/28
06/28
NCT06506084: Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)

Recruiting
N/A
319
Europe
Ropeginterferon alfa-2b, Besremi
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Polycythemia Vera
09/26
12/26
NCT05494528: Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy

Recruiting
N/A
90
RoW
Ropeginterferon alfa-2b, P1101, Entecavir
National Taiwan University Hospital, PharmaEssentia
Chronic Hepatitis B Virus Infection
12/23
12/24
ROPE, NCT06743035: Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly

Recruiting
N/A
200
Europe
iOMEDICO AG, AOP Orphan Pharmaceuticals Germany GmbH
Polycythemia Vera
07/29
07/29
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Estybon (rigosertib) / Traws Pharma, SymBio Pharma, Knight Therap
2016-003832-19: Clinical Trial to evaluate the efficacy of the drug "Rigosertib" against non- melanoma skin cancer in "Butterfly Children". Klinische Studie um die Wirksamkeit des Medikaments Rigosertib gegen weißen Hautkrebs bei "Schmetterlingskindern" zu bewerten

Ongoing
2
12
Europe
Rigosertib, ON 01910.Na, Capsule, soft, Concentrate for solution for infusion, Concentrate for oral solution
Gemeinn. Salzburger Landeskliniken BetriebsGesmbH, University Hospital for Dermatology, EB-House Austria, DEBRA International
Recessive dystrophic epidermolysis bullosa (RDEB) is a severe genodermatose caused by mutations in COL7A1, characterized by generalized skin blistering and involvement of mucous membranes. Aggressive metastasizing squamous cell carcinomas (SCCs) are a common complication, which reduce patients’ average life expectancy to less than 40 years. The aim of this study is to evaluate anti-tumor activity of oral Rigosertib, a PLK1 inhibitor, in RDEB patients diagnosed with SCCs. Rezessiv dystrophe Epidermolysis bullosa (RDEB) ist eine Genodermatose, die durch COL7A1 Mutationen entsteht und durch generalisierte Blasenbildung und Beteiligung von Schleimhäuten charakterisiert ist. Die Patienten leiden an chronischen Wunden in denen sich oft agressive methastasierend Plattenepithelkarzinome bilden, die die Lebenserwartung auf unter 40 Jahre senken. Ziel der Studie ist die Anti-Tumor Wirkung von oralem Rigosertib in RDEB- Patienten mit Plattenepithelkarzinomen zu bewerten., Metastasizing non-melanoma skin cancer is a severe complication of recessive dystrophic epidermolysis bullosa. A new drug against this form of cancer shall be tested in this trial. Eine schwerwiegende Komplikationen von rezessiv dystropher Epidermolysis bullosa ist metastasierender weißer Hautkrebs. In der Studie soll ein neues Medikament gegen diesen Krebs getestet werden, Diseases [C] - Cancer [C04]
 
 
NCT05764395: Rigosertib Plus Pembrolizumab in Treating Patients With Unresectable/Metastatic Melanoma Refractory to PD-1 Inhibitors

Suspended
2
29
US
Rigosertib, Pembrolizumab, Magnetic Resonance Imaging, Biospecimen Collection, Biopsy
Vanderbilt-Ingram Cancer Center
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8, Metastatic Melanoma, Refractory Melanoma, Unresectable Melanoma
05/28
05/29
NCT04263090: Rigosertib Plus Nivolumab for KRAS+ NSCLC Patients Who Progressed on First-Line Treatment

Checkmark Presentation of P1/2 data in combination with nivolumab for treatment of advanced KRAS+ NSCLC
Sep 2022 - Sep 2022: Presentation of P1/2 data in combination with nivolumab for treatment of advanced KRAS+ NSCLC
Checkmark Data from trial in combination with nivolumab in progressive K-RAS mutated NSCLC
Sep 2021 - Sep 2021: Data from trial in combination with nivolumab in progressive K-RAS mutated NSCLC
Completed
1/2
25
US
Rigosertib, Nivolumab
Icahn School of Medicine at Mount Sinai, Bristol-Myers Squibb, Traws Pharma, Inc.
Non-small Cell Lung Cancer, Adenocarcinoma, Stage IV
12/23
12/23
NCT03786237: Rigosertib for RDEB-SCC

Recruiting
1/2
12
Europe
Rigosertib Oral Capsules / Rigosertib Intravenous
Prof. Johann Bauer
Epidermolysis Bullosa Dystrophica, Squamous Cell Carcinoma
12/25
06/26
NCT04177498: Rigosertib in Patients With Recessive Dystrophic Epidermolysis Bullosa Associated SCC

Active, not recruiting
1
6
US
Rigosertib Sodium, ON 01910.Na, Quality-of-Life Assessment, Quality of Life Assessment
Thomas Jefferson University, Traws Pharma, Inc.
Recessive Dystrophic Epidermolysis Bullosa
05/25
06/25
Orladeyo (berotralstat) / BioCryst
APeX-P, NCT05453968 / 2021-005932-50: Berotralstat Treatment in Children With Hereditary Angioedema

Active, not recruiting
3
29
Europe, Canada, RoW
Berotralstat, BCX7353, Orladeyo®
BioCryst Pharmaceuticals
Hereditary Angioedema, Pediatric
09/24
02/27
APeX-A, NCT04933721 / 2020-004230-37: Open-label Berotralstat Access to HAE Patients Previously Enrolled in Berotralstat Studies

Active, not recruiting
3
139
Europe, RoW
berotralstat, Orladeyo
BioCryst Pharmaceuticals
Hereditary Angioedema, HAE
08/31
08/31
2015-003923-74: A placebo controlled trial of of three doses of BCX7353 to evaluate the safety and efficacy in the prevention of attacks in patients with HAE

Ongoing
2
24
Europe
BC7353, BCX7353, Capsule, hard
BioCryst Pharmaceuticals Inc, BioCryst Pharmaceutical Inc
Hereditary Angioedema, Hereditary Angioedema, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
Besremi (ropeginterferon alfa-2b-njft) / PharmaEssentia
PARADIGM-PV, NCT06290765: Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera

Not yet recruiting
4
70
NA
Ropeginterferon alfa-2b, P1101, Phlebotomy and aspirin, Phlebotomy and aspirin plus the other cytoreductive agents
PharmaEssentia
Polycythemia Vera, Myeloproliferative Neoplasm
12/26
06/27
ENDURE-CML-IX, NCT03117816 / 2016-001030-94: ENDURE - Efficacy and Safety of AOP2014 With CML Patients in Remission

Completed
3
214
Europe
AOP2014 / Pegylated-Proline-interferon alpha-2b, Surveillance
Philipps University Marburg Medical Center, Deutsche Krebshilfe e.V., Bonn (Germany), AOP Orphan Pharmaceuticals AG
Chronic Myeloid Leukemia in Remission
01/22
12/22
ChiCTR2000036395: A Phase 3, Open-Label, Multicenter, Randomized, Active-Controlled Study to Assess Pharmacokinetics and Compare the Efficacy, Safety, and Tolerability of P1101 vs Anagrelide as Second Line Therapy for Essential Thrombocythemia

Not yet recruiting
3
160
 
Subcutaneous injection of drug P1101 ;Take anaglyl orally
Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences; PharmaEssentia Corporation, PharmaEssentia Corporation
Essential Thrombocythemia
 
 
SURPASS ET, NCT04285086: Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance

Hourglass Oct 2024 - Dec 2024 : Data for 2L essential thrombocythemia
Active, not recruiting
3
174
Canada, Japan, US, RoW
Ropeginterferon alfa-2b, P1101, Anagrelide
PharmaEssentia, Medpace, Inc., EPS International, Brightech International
Essential Thrombocythemia
11/24
12/25
ROP-ET, NCT06514807: A Study to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in Essential Thrombocythaemia Patients

Active, not recruiting
3
117
Europe, RoW
Ropeginterferon alfa-2b (BESREMi®)
AOP Orphan Pharmaceuticals AG
Essential Thrombocythaemia
03/28
03/28
NCT05770466: Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Moderate COVID19.

Completed
3
134
RoW
P1101 (Ropeginterferon alfa-2b), SOC
National Taiwan University Hospital
COVID-19
12/22
01/23
ECLIPSE-PV, NCT05481151: A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV

Hourglass Feb 2024 - Dec 2024 : Topline data for adults with PV
Active, not recruiting
3
111
Canada, US
P1101 (Ropeginterferon alfa-2b-njft), Ropeginterferon alfa-2b-njft (P1101)
PharmaEssentia
Polycythemia Vera
12/24
07/25
NCT06002490: A Study to Evaluate P1101 in Japanese PV Patients

Completed
3
21
Japan
P1101, Ropeginterferon alfa-2b, Low-dose aspirin, Low-doaw Acetylsalicylic acid, Phlebotomy
PharmaEssentia Japan K.K.
Polycythemia Vera (PV)
07/24
07/24
NCT04655092: Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients

Recruiting
3
67
Japan
P1101 (Ropeginterferon alfa-2b)
PharmaEssentia Japan K.K.
Polycythemia Vera (PV)
06/26
06/26
NCT06468033: P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk

Not yet recruiting
3
150
NA
Ropeginterferon alfa-2b, P1101, Placebo
PharmaEssentia
Primary Myelofibrosis, Myeloproliferative Neoplasm
03/27
04/28
2016-001030-94: Efficacy and safety of pegylated-proline-interferon alpha 2B (AOP2014) in maintaining deep molecular remissions in patients with chronic myeloid leukemia who discontinue ABL-kinase inhibitory therapy, with post-study follow-up. Randomisierte Phase III Studie zur Untersuchung der Sicherheit und Effektivität einer Therapie mit pegyliertem Prolin-Interferon alpha 2b (AOP2014) in der Erhaltung einer tiefen molekularen Remission bei Patienten mit chronischer myeloischer Leukämie, die die bisherige Standardtherapie nach zwei Wochen absetzen, mit anschließender Nachbeobachtungsphase außerhalb der Studie

Not yet recruiting
2/3
214
Europe
AOP2014, Solution for injection in pre-filled pen, Besremi
Philipps University Marburg, Deutsche Krebshilfe
Chronic myeloid leukemia Die chronische myeloische Leukämie, Chronic myeloid leukemia Die chronische myeloische Leukämie, Diseases [C] - Cancer [C04]
 
 
NCT05808322: Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities

Not yet recruiting
2/3
60
RoW
Ropeginterferon alfa-2b, P1101, SOC
National Taiwan University Hospital
COVID-19
05/24
12/24
2014-001367-13: The study to assess the efficacy and safety of new Interferon alpha-2b formulation in patients with primary myelofibrosis

Ongoing
2
24
Europe
Pegylated proline-interferon alpha- 2b, AOP2014,
Medizinische Universtät Wien, Universitätsklinik für Innere Medizin I, AOP ORPHAN PHARMACEUTICALS AG
Primary Myelofibrosis (grade MF-0 and MF-1) according to the WHO criteria
 
 
2018-001044-54: A study of effect and safety of a new combination of drugs for chronic myeloid leukemia in chronic phase. Bosutinib is the basis treatment and patients will be randomized to receive or not to receive a long-acting low dose of Ropeginterferon. Satunnaistettu, etenevä KML:n ensilinjan lääkehoitotutkimus: Lääkeaineen tehoa ja turvallisuutta mittaava tutkimus, jossa pieniannoksinen ropeginterferoni lisätään bosutinibihoitoon hiljattain diagnosoitua, kroonisessa vaiheessa olevaa kroonista myelooista meukemiaa sairastavilla potilailla.

Not yet recruiting
2
212
Europe
Pegylated proline-interferon alpha 2b, AOP2014, Tablet, Solution for injection in pre-filled pen, Bosulif
St Olavs Hospital -Trondheim University Hospital, Pfizer Norge AS, AOP Orphan Pharmaceuticals AG
Chronic myeloid leukemia at diagnosis-chronich phase Diagnoosivaiheen krooninen myelooinen leukemia, kroonisessa vaiheessa, Chronic myeloid leukemia, a type of blood cancer Krooninen myelooinen leukemia, verisyöpätyyppi, Diseases [C] - Cancer [C04]
 
 
NCT03003325 / 2015-004717-25: The Benefit/Risk Profile of AOP2014 in Low-risk Patients With PV

Completed
2
127
Europe
AOP2014, Pegylated-Proline-Interferon α-2b, P1101, Phlebotomies, blood removing, ASA, Acetylsalicylic Acid
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS, AOP Orphan Pharmaceuticals AG
Polycythemia Vera
03/22
03/23
NCT05485948: A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU

Active, not recruiting
2
49
RoW
Ropeginterferon alfa-2b, BESREMI
PharmaEssentia
Polycythemia Vera
09/22
05/25
EXCEED ET, NCT05482971: A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET

Active, not recruiting
2
91
Canada, US
Ropeginterferon alfa-2b-njft (P1101), P1101
PharmaEssentia
Essential Thrombocythemia
03/27
03/27
NCT02370329: P1101 in Treating Patients with Myelofibrosis

Completed
2
11
US
Laboratory Biomarker Analysis, Quality-of-Life Assessment, Quality of Life Assessment, Ropeginterferon Alfa-2B, AOP2014, Besremi, P-1101, P1101, PEG-P-IFN-Alfa-2b, PEG-P-IFN-Alpha-2b, PEG-Proline-Interferon Alfa-2b
Mayo Clinic, National Cancer Institute (NCI)
Primary Myelofibrosis, Secondary Myelofibrosis
11/23
11/23
NCT05731245: Ropeginterferon Alfa 2b for Early MyelofibrosisDIPSS Low/Intermediate-1 Risk Myelofibrosis

Recruiting
2
50
RoW
Ropeginterferon Alfa-2B Prefilled Syringe [Besremi]
National Taiwan University Hospital
Pre-fibrotic Myelofibrosis
10/24
10/26
NCT05467553: A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection

Not yet recruiting
2
30
RoW
Ursodeoxycholic acid, Uroso Tablets, Ropeginterferon alfa-2b, BESREMI, Tenofovir Alafenamide, Vemlidy
National Taiwan University Hospital, PharmaEssentia
Hepatitis D
02/25
08/25
NCT06770842: Ropeginterferon Alfa 2b Plus Ruxolitinib for Myelofibrosis

Recruiting
2
20
RoW
Ropeginterferon alfa-2b (BESREMi®)
The University of Hong Kong
Primary Myelofibrosis (PMF), Post Polycythemia Myelofibrosis (PPV MF), Post Essential Thrombocythaemia Myelofibrosis (PET-MF)
12/26
12/27
P1101MF, NCT04988815: Ropeginterferon Alfa 2b for Early Myelofibrosis

Recruiting
2
50
RoW
Ropeginterferon alfa-2b
The University of Hong Kong
Primary Myelofibrosis, Prefibrotic Stage, Myelofibrosis
07/25
12/25
NCT04233840: P1101 and Anti-PD1 for After Curative Surgery of Hepatitis B-related Hepatocellular Carcinoma

Recruiting
1/2
72
RoW
P1101 (Ropeginterferon alfa-2b), Nivolumab, Opdivo
National Taiwan University Hospital, PharmaEssentia
Hepatocellular Carcinoma
12/22
07/23
NCT04638439: The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection

Completed
1
20
RoW
P1101 + Nivolumab + Entecavir, P1101 (Ropeginterferon alfa-2b) + Nivolumab + Entecavir
PharmaEssentia
Chronic Hepatitis B Infection, Chronic Hepatitis D Infection
05/25
05/25
NCT07047885: Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)

Recruiting
1
38
US
Ropeginterferon alfa-2b, P1101
H. Lee Moffitt Cancer Center and Research Institute, PharmaEssentia
Cutaneous T Cell Lymphoma
06/28
06/28
NCT06506084: Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)

Recruiting
N/A
319
Europe
Ropeginterferon alfa-2b, Besremi
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Polycythemia Vera
09/26
12/26
NCT05494528: Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy

Recruiting
N/A
90
RoW
Ropeginterferon alfa-2b, P1101, Entecavir
National Taiwan University Hospital, PharmaEssentia
Chronic Hepatitis B Virus Infection
12/23
12/24
ROPE, NCT06743035: Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly

Recruiting
N/A
200
Europe
iOMEDICO AG, AOP Orphan Pharmaceuticals Germany GmbH
Polycythemia Vera
07/29
07/29

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