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14 Trials

   

Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Olysio (simeprevir) / J&J, Medivir
NCT01727323 / 2010-021337-31: A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1

Active, not recruiting
3
109
US, Canada, Europe
TMC435, Pegylated interferon alpha-2a, Ribavirin
Janssen Research & Development, LLC, Janssen R&D Ireland, Tibotec Pharmaceuticals
Hepatitis C Virus Genotype-1
08/13
08/13
NCT02256176 / 2014-003446-27: Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Not yet recruiting
3
40
Europe
Simeprevir, TMC435, Sofosbuvir
Janssen R&D Ireland, Janssen R&D Ireland
Chronic Hepatitis C, Genotype 4 Chronic Hepatitis C
11/15
01/16
NCT05616598: Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters

Completed
2/3
200
RoW
Sofosbuvir +daclatasvir+ simeprevir+Ribavirin
Benha University
Male Infertility, HCV
11/22
12/22
SWITCH-1, NCT02583685: Switching Regimen in Treating Cirrhotic HCV GT1b Subjects

Completed
2
138
RoW
PR4 + LDV/SOF + ASV 4 wk, Pegasys®, Copegus®, Harvoni®, Sunvepra®, PR4 + LDV/SOF + SMV 4 wk, OLYSIO®, PR4 + LDV/SOF + ASV 6 wk, PR4 + LDV/SOF + SMV 6 wk, PR4 + LDV/SOF + ASV 8 wk, PR4 + LDV/SOF + SMV 8 wk, PR4 + LDV/SOF + ASV 12 wk, PR4 + LDV/SOF + SMV 12 wk
Humanity and Health Research Centre, Beijing 302 Hospital, Nanfang Hospital, Southern Medical University
Chronic Hepatitis C Infection
10/24
10/24
NCT05728619: HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer

Recruiting
1b/2
64
RoW
HTMC0435, Temozolomide
Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Recurrent Extensive Stage Small Cell Lung Carcinoma
08/24
10/24
CTR20200573: Phase I/II clinical trial evaluating HTMC0435 tablets in patients with advanced malignant solid tumors

Recruiting
1/2
42
China
HTMC0435 - Shanghai Huilun
Shanghai Huilun Life Technology Co., Ltd./Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Avanced malignant solid tumors
 
 
ChiCTR2500100955: A dose exploration and dose expansion phase Ib/II study to evaluate oral HTMC0435 tablets in combination with platinum and etoposide in patients with extensive stage small cell lung cancer

Recruiting
1/2
74
 
HTMC0435 tablets 8 mg, bid, continued daily oral administration, each dose group combined with etoposide 75 mg/m^2, intravenous infusion for about 60 minutes, for 3 days (day 1 to day 3 of each treatment cycle), combined with cisplatin 20mg/m^2 (intravenous infusion > 1h), for a total of 3 days (days 1 to 3 of each treatment cycle) or carboplatin AUC4 (intravenous infusion for 30-60min), a total of 1 day (day 1 of each treatment cycle), 21 days per treatment cycle, A total of 4-6 cycles of treatment. In principle, the subsequent escalation dose was increased in the ratio of ×1.33 (33%).; HTMC0435 tablets 12 mg, bid, continuous oral administration every day, each dose group combined with etoposide 75 mg/m^2, intravenous infusion for about 60 minutes, for 3 days (day 1 to day 3 of each treatment cycle), combined with cisplatin 20mg/m^2 (intravenous infusion > 1h), for a total of 3 days (days 1 to 3 of each treatment cycle) or carboplatin AUC4 (intravenous infusion for 30-60min), a total of 1 day (day 1 of each treatment cycle), each treatment cycle of 21 days for a total of 4-6 cycles of treatment. In principle, the subsequent escalation dose was increased in the ratio of ×1.33 (33%).; The preliminary efficacy of the combination in patients with extensive-stage small cell lung cancer was investigated at the dose of HTMC0435 tablets in combination with cisplatin/carboplatin and etoposide RP2D. Subjects who have no progression after 4-6 cycles of treatment and are tolerated after investigator safety assessment will continue to be treated with HTMC0435 single-agent RP2D dose maintenance therapy.
The First Affiliated Hospital of Zhengzhou University; Shanghai Yidian Pharmaceutical Technology Development Co., Ltd., Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Small Cell Lung Cancer
 
 
Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer International, Galen, Medivir
2016-004884-38: Evaluation of the effectiveness of loxapine in agitated patients with personality disorder Evaluación de la eficacia de la loxapina en pacientes agitados con trastorno de personalidad

Ongoing
4
30
Europe
Inhalation powder, pre-dispensed, ADASUVE 9.1 mg inhalation powder, pre-dispensed
Vall d'Hebron University Hospital, Vall d'Hebron University Hospital
Acute pre/agitated patients with personality disorder Agitación en pacientes con trastorno de personalidad., Patients with personality disorder that arrive to the ER with an acute pre/agitation state Pacientes con trastorno de personalidad que acuden a urgencias en un estado de agitación o pre-agitación agudo., Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
NCT03513549: Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder

Recruiting
N/A
10000
US
Loxapine 10 MG, ADASUVE (loxapine) inhalation powder, NDA 022549
Alexza Pharmaceuticals, Inc., Pharmaceutical Research Associates
Agitation,Psychomotor
10/21
03/22
birinapant (IGM-9427) / IGM Biosciences
NCT03809208: Birinapant and Intensity Modulated Re-Irradiation Therapy for Local-Regionally Recurrent Head and Neck Squamous Cell Carcinoma

Recruiting
1
34
US
Birinapant, Intensity modulated re-irradiation therapy (IMMRT)
National Cancer Institute (NCI)
Head Cancer, Facial Cancer, Neck Cancer, Upper AerodigestiveTract Cancer, Oral Cancer
10/20
10/21
NCT03803774: Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma

Active, not recruiting
1
13
US
Biopsy Procedure, Biopsy, BIOPSY_TYPE, Bx, Birinapant, TL32711, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Intensity-Modulated Radiation Therapy, IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
National Cancer Institute (NCI)
Locally Recurrent Head and Neck Squamous Cell Carcinoma, Nasopharyngeal Squamous Cell Carcinoma, Sinonasal Squamous Cell Carcinoma
11/23
03/26
IGM-8444-001, NCT04553692: Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers

Terminated
1
272
Europe, US, RoW
Aplitabart (IGM-8444), FOLFIRI, Fluorouracil or 5-FU, Leucovorin, Irinotecan, Bevacizumab (and approved biosimilars), Avastin, Birinapant, Venetoclax, Venclexta, Gemcitabine, Gemzar, Docetaxel, Taxotere, Docefrez, Azacitidine, VIDAZA
IGM Biosciences, Inc.
Solid Tumor, Colorectal Cancer, Non Hodgkin Lymphoma, Sarcoma, Chondrosarcoma, Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia, Acute Myeloid Leukemia
01/25
01/25
fostroxacitabine bralpamide (MIV-818) / Medivir
MIV-818-101, NCT03781934 / 2018-000995-14: A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations

Completed
1/2
53
Europe, RoW
MIV-818 (fostroxacitabine bralpamide) + pembrolizumab, MIV-818 (fostroxacitabine bralpamide) + lenvatinib
Medivir
Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Liver Metastases
01/25
06/25
TNG348 / Tango Therap
NCT06065059: Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors

Terminated
1/2
7
US
TNG348, Olaparib, Lynparza
Tango Therapeutics, Inc.
Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer, BRCA1 Mutation, BRCA-Mutated Ovarian Carcinoma, BRCA-Associated Breast Carcinoma, HRD Positive Advanced Ovarian Cancer
05/24
05/24
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Olysio (simeprevir) / J&J, Medivir
NCT01727323 / 2010-021337-31: A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1

Active, not recruiting
3
109
US, Canada, Europe
TMC435, Pegylated interferon alpha-2a, Ribavirin
Janssen Research & Development, LLC, Janssen R&D Ireland, Tibotec Pharmaceuticals
Hepatitis C Virus Genotype-1
08/13
08/13
NCT02256176 / 2014-003446-27: Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Not yet recruiting
3
40
Europe
Simeprevir, TMC435, Sofosbuvir
Janssen R&D Ireland, Janssen R&D Ireland
Chronic Hepatitis C, Genotype 4 Chronic Hepatitis C
11/15
01/16
NCT05616598: Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters

Completed
2/3
200
RoW
Sofosbuvir +daclatasvir+ simeprevir+Ribavirin
Benha University
Male Infertility, HCV
11/22
12/22
SWITCH-1, NCT02583685: Switching Regimen in Treating Cirrhotic HCV GT1b Subjects

Completed
2
138
RoW
PR4 + LDV/SOF + ASV 4 wk, Pegasys®, Copegus®, Harvoni®, Sunvepra®, PR4 + LDV/SOF + SMV 4 wk, OLYSIO®, PR4 + LDV/SOF + ASV 6 wk, PR4 + LDV/SOF + SMV 6 wk, PR4 + LDV/SOF + ASV 8 wk, PR4 + LDV/SOF + SMV 8 wk, PR4 + LDV/SOF + ASV 12 wk, PR4 + LDV/SOF + SMV 12 wk
Humanity and Health Research Centre, Beijing 302 Hospital, Nanfang Hospital, Southern Medical University
Chronic Hepatitis C Infection
10/24
10/24
NCT05728619: HTMC0435 and Temozolomide in Treating Patients With Small Cell Lung Cancer

Recruiting
1b/2
64
RoW
HTMC0435, Temozolomide
Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Recurrent Extensive Stage Small Cell Lung Carcinoma
08/24
10/24
CTR20200573: Phase I/II clinical trial evaluating HTMC0435 tablets in patients with advanced malignant solid tumors

Recruiting
1/2
42
China
HTMC0435 - Shanghai Huilun
Shanghai Huilun Life Technology Co., Ltd./Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Avanced malignant solid tumors
 
 
ChiCTR2500100955: A dose exploration and dose expansion phase Ib/II study to evaluate oral HTMC0435 tablets in combination with platinum and etoposide in patients with extensive stage small cell lung cancer

Recruiting
1/2
74
 
HTMC0435 tablets 8 mg, bid, continued daily oral administration, each dose group combined with etoposide 75 mg/m^2, intravenous infusion for about 60 minutes, for 3 days (day 1 to day 3 of each treatment cycle), combined with cisplatin 20mg/m^2 (intravenous infusion > 1h), for a total of 3 days (days 1 to 3 of each treatment cycle) or carboplatin AUC4 (intravenous infusion for 30-60min), a total of 1 day (day 1 of each treatment cycle), 21 days per treatment cycle, A total of 4-6 cycles of treatment. In principle, the subsequent escalation dose was increased in the ratio of ×1.33 (33%).; HTMC0435 tablets 12 mg, bid, continuous oral administration every day, each dose group combined with etoposide 75 mg/m^2, intravenous infusion for about 60 minutes, for 3 days (day 1 to day 3 of each treatment cycle), combined with cisplatin 20mg/m^2 (intravenous infusion > 1h), for a total of 3 days (days 1 to 3 of each treatment cycle) or carboplatin AUC4 (intravenous infusion for 30-60min), a total of 1 day (day 1 of each treatment cycle), each treatment cycle of 21 days for a total of 4-6 cycles of treatment. In principle, the subsequent escalation dose was increased in the ratio of ×1.33 (33%).; The preliminary efficacy of the combination in patients with extensive-stage small cell lung cancer was investigated at the dose of HTMC0435 tablets in combination with cisplatin/carboplatin and etoposide RP2D. Subjects who have no progression after 4-6 cycles of treatment and are tolerated after investigator safety assessment will continue to be treated with HTMC0435 single-agent RP2D dose maintenance therapy.
The First Affiliated Hospital of Zhengzhou University; Shanghai Yidian Pharmaceutical Technology Development Co., Ltd., Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Small Cell Lung Cancer
 
 
Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer International, Galen, Medivir
2016-004884-38: Evaluation of the effectiveness of loxapine in agitated patients with personality disorder Evaluación de la eficacia de la loxapina en pacientes agitados con trastorno de personalidad

Ongoing
4
30
Europe
Inhalation powder, pre-dispensed, ADASUVE 9.1 mg inhalation powder, pre-dispensed
Vall d'Hebron University Hospital, Vall d'Hebron University Hospital
Acute pre/agitated patients with personality disorder Agitación en pacientes con trastorno de personalidad., Patients with personality disorder that arrive to the ER with an acute pre/agitation state Pacientes con trastorno de personalidad que acuden a urgencias en un estado de agitación o pre-agitación agudo., Psychiatry and Psychology [F] - Mental Disorders [F03]
 
 
NCT03513549: Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder

Recruiting
N/A
10000
US
Loxapine 10 MG, ADASUVE (loxapine) inhalation powder, NDA 022549
Alexza Pharmaceuticals, Inc., Pharmaceutical Research Associates
Agitation,Psychomotor
10/21
03/22
birinapant (IGM-9427) / IGM Biosciences
NCT03809208: Birinapant and Intensity Modulated Re-Irradiation Therapy for Local-Regionally Recurrent Head and Neck Squamous Cell Carcinoma

Recruiting
1
34
US
Birinapant, Intensity modulated re-irradiation therapy (IMMRT)
National Cancer Institute (NCI)
Head Cancer, Facial Cancer, Neck Cancer, Upper AerodigestiveTract Cancer, Oral Cancer
10/20
10/21
NCT03803774: Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma

Active, not recruiting
1
13
US
Biopsy Procedure, Biopsy, BIOPSY_TYPE, Bx, Birinapant, TL32711, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography, Intensity-Modulated Radiation Therapy, IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy, Radiation, Intensity-Modulated Radiotherapy, Magnetic Resonance Imaging, Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI, Positron Emission Tomography, Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT
National Cancer Institute (NCI)
Locally Recurrent Head and Neck Squamous Cell Carcinoma, Nasopharyngeal Squamous Cell Carcinoma, Sinonasal Squamous Cell Carcinoma
11/23
03/26
IGM-8444-001, NCT04553692: Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants with Relapsed, Refractory, or Newly Diagnosed Cancers

Terminated
1
272
Europe, US, RoW
Aplitabart (IGM-8444), FOLFIRI, Fluorouracil or 5-FU, Leucovorin, Irinotecan, Bevacizumab (and approved biosimilars), Avastin, Birinapant, Venetoclax, Venclexta, Gemcitabine, Gemzar, Docetaxel, Taxotere, Docefrez, Azacitidine, VIDAZA
IGM Biosciences, Inc.
Solid Tumor, Colorectal Cancer, Non Hodgkin Lymphoma, Sarcoma, Chondrosarcoma, Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia, Acute Myeloid Leukemia
01/25
01/25
fostroxacitabine bralpamide (MIV-818) / Medivir
MIV-818-101, NCT03781934 / 2018-000995-14: A Study to Evaluate MIV-818 in Patients With Liver Cancer Manifestations

Completed
1/2
53
Europe, RoW
MIV-818 (fostroxacitabine bralpamide) + pembrolizumab, MIV-818 (fostroxacitabine bralpamide) + lenvatinib
Medivir
Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, Liver Metastases
01/25
06/25
TNG348 / Tango Therap
NCT06065059: Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors

Terminated
1/2
7
US
TNG348, Olaparib, Lynparza
Tango Therapeutics, Inc.
Breast Cancer, Ovarian Cancer, Pancreas Cancer, Prostate Cancer, BRCA1 Mutation, BRCA-Mutated Ovarian Carcinoma, BRCA-Associated Breast Carcinoma, HRD Positive Advanced Ovarian Cancer
05/24
05/24

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