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16 Products |  |
56 Diseases | | 16 Products |
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38 Trials |  |
954 News |  |
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- | Atenativ (human antithrombin III) / Octapharma
Trial completion date, Trial primary completion date, Surgery: ATN-106: Efficacy of Atenativ in Patients with Congenital Antithrombin Deficiency Undergoing Surgery or Delivery (clinicaltrials.gov) - Sep 20, 2021
P3, N=34, Not yet recruiting, Sponsor: Octapharma
Trial completion date: Jul 2024 --> Dec 2024 | Trial primary completion date: Jul 2024 --> Dec 2024
- || Fibryga (fibrinogen concentrate (human)) / Octapharma
Clinical, Clinical protocol, Journal, Head-to-Head: Protocol for a multicentre, randomised, parallel-control, superiority trial comparing administration of clotting factor concentrates with a standard massive haemorrhage protocol in severely bleeding trauma patients: the FiiRST 2 trial (a 2020 EAST multicentre trial). (Pubmed Central) - Sep 17, 2021
P4
Fibrinogen concentrate (FC) and prothrombin complex concentrate (PCC) are two purified concentrates of clotting factors that have been used to treat ATC...If superiority is established, results will have a major impact on clinical practice by reducing exposure to non-virally inactivated blood products, shortening the time for administration of clotting factors, correct coagulopathy more efficaciously and reduce the reliance on AB plasma. NCT04534751, pre results.
- Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
Pain in the right leg. Analysis of a case. () - Sep 7, 2021 - Abstract #EUSEM2021EUSEM_811;
Retroperitoneal hematoma is a rare but potentially lethal entity that can present various clinical manifestations, which can be very non-specific with confusion in diagnosis and therefore delaying treatment. Having normal hemoglobin at onset does not always rule out active bleeding.
- || Gammanorm (human immune globulin subcutaneous) / Octapharma
Clinical, Journal: Efficacy and safety of octanorm (cutaquig) in adults with primary immunodeficiencies with predominant antibody deficiency: a prospective, open-label study. (Pubmed Central) - Aug 21, 2021
P3
Octanorm is effective, safe and improves quality of life. Clinical Trial registration number: NCT03988426.
- || Atenativ (human antithrombin III) / Octapharma
Trial completion date, Trial primary completion date: Observational, Retrospective Study to Evaluate Coagulation Changes and the Influence of Antithrombin III Treatment in Patients With Severe COVID-19 Infection (clinicaltrials.gov) - Aug 18, 2021
P=N/A, N=300, Recruiting, Sponsor: Octapharma
Clinical Trial registration number: NCT03988426. Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Jun 2021 --> Dec 2021
- |||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
FDA event: Popular on RheumNow https://t.co/BZsl8a6ArW The U.S. Food and Drug Administration (FDA) has approved Octagam 10% [Immune Globulin Intravenous (Human)], as the first and only intravenous immunoglobulin (IVIg) formulation to be approved for adult dermatomyositis (DM). (Twitter) - Aug 16, 2021
- |||| Panzyga (immune globulin intravenous, human-ifas) / Octapharma, Pfizer
Enrollment open, Head-to-Head: NGAM-13: Phase III Study To Compare The Effect of Panzyga Versus Placebo in Patients With Pediatric Acute-onset Neuropsychiatric Syndrome (PANS/PANDAS) (clinicaltrials.gov) - Aug 11, 2021
P3, N=92, Recruiting, Sponsor: Octapharma
Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Jun 2021 --> Dec 2021 Not yet recruiting --> Recruiting
- || Wilate (human factor VIII/von Willebrand factor) / Octapharma
Enrollment open: Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of Age (clinicaltrials.gov) - Aug 8, 2021
P3, N=12, Recruiting, Sponsor: Octapharma
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || Clinical, Journal: Pharmacotherapeutic Patterns and Patients' Access to Pharmacotherapy for Some Rare Diseases in Bulgaria - A Pilot Comparative Study. (Pubmed Central) - Aug 6, 2021
Bulgarian patients with cystic fibrosis with pulmonary manifestation had a wait time of only 1.6 years to get access to innovative, centrally authorized medicines, whereas the period for access to acromegaly treatment was 8.2 years. The main factors influencing market entrance and patient access are the time to inclusion in the PDL and the NHIF criteria.
- | simoctocog alpha/von Willebrand Factor (OCTA101) / Octapharma
Enrollment closed: Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A (clinicaltrials.gov) - Aug 4, 2021
P1/2, N=36, Active, not recruiting, Sponsor: Octapharma
The main factors influencing market entrance and patient access are the time to inclusion in the PDL and the NHIF criteria. Recruiting --> Active, not recruiting
- |||| Gammanorm (human immune globulin subcutaneous) / Octapharma
Enrollment closed, Trial completion date, Trial primary completion date: Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases (clinicaltrials.gov) - Aug 4, 2021
P3, N=64, Active, not recruiting, Sponsor: Octapharma
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial completion date: Jul 2021 --> Jan 2022 | Trial primary completion date: Jul 2021 --> Jan 2022
- ||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
FDA event: ICYMI: FDA Approves IVIG in Dermatomyositis https://t.co/PoHtzDYekk The FDA has approved Octagam 10% [Immune Globulin Intravenous (Human)], as the first and only intravenous immunoglobulin (IVIg) formulation to be approved for adult dermatomyositis (DM). (Twitter) - Aug 3, 2021
- ||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
FDA event: ICYMI: FDA Approves IVIG in Dermatomyositis https://t.co/BZsl8a6ArW The FDA has approved Octagam 10% [Immune Globulin Intravenous (Human)], as the first and only intravenous immunoglobulin (IVIg) formulation to be approved for adult dermatomyositis (DM). (Twitter) - Jul 24, 2021
- ||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
FDA event: FDA Approves IVIG in Dermatomyositis https://t.co/BZsl8a6ArW The FDA has approved Octagam 10% [Immune Globulin Intravenous (Human)], as the first and only intravenous immunoglobulin (IVIg) formulation to be approved for adult dermatomyositis (DM). (Twitter) - Jul 21, 2021
- ||||| Octagam (intravenous normal human immunoglobulin) / Octapharma
FDA event: FDA Approves Octapharma’s Octagam® 10% for Adult Dermatomyositis https://t.co/e7z632ysCO (Twitter) - Jul 20, 2021
- | Neofordex (dexamethasone acetate high-dose) / CTRS Laboratories
New P3 trial: IVIORDEX: IgIV Plus Prednisone vs High-dose Dexamethasone for ITP (clinicaltrials.gov) - Jul 19, 2021
P3, N=272, Not yet recruiting, Sponsor: Assistance Publique - H
- || Octagam (intravenous normal human immunoglobulin) / Octapharma
Rt @docrota : « IgIV approuvée par la FDA (Octagam 10 %) par @OctapharmaGroup pour la #dermatomyosite de l'adulte. Le premier et le seul traitement éprouvé et approuvé pour la #myosite… » #immunoglobulines #myosites ⤵️ (Twitter) - Jul 18, 2021
- |||| Octagam (intravenous normal human immunoglobulin) / Octapharma
Clinical, FDA event: Hot off the press! The best news Ever - for Myositis. FDA approved IVIG (Octagam 10%) by @OctapharmaGroup for adult Dermatomyositis. First & the only proven & approved tx for Myositis. History is made today. Congratulations & thanks to all patients and doctors and study staff. (Twitter) - Jul 17, 2021
- |||| Balfaxar (prothrombin complex concentrate, human-lans) / Octapharma, Pfizer
Trial completion date, Trial primary completion date, Surgery: Study of Octaplex, a Four-factor Prothrombin Complex Concentrate (4F-PCC) and Beriplex (clinicaltrials.gov) - Jul 15, 2021
P3, N=370, Recruiting, Sponsor: Octapharma
Recruiting --> Active, not recruiting | Trial completion date: Jul 2021 --> Jan 2022 | Trial primary completion date: Jul 2021 --> Jan 2022 Trial completion date: Jun 2021 --> Dec 2021 | Trial primary completion date: Jun 2021 --> Dec 2021
- || Wilate (human factor VIII/von Willebrand factor) / Octapharma
Clinical, Journal, Real-world evidence: Real-World Data on the Effectiveness and Safety of wilate for the Treatment of von Willebrand Disease. (Pubmed Central) - Jul 9, 2021
Effectiveness was assessed as "excellent" or "good" by patients and investigators for 100% of BEs treated on-demand, 98% (patient rating) and 99% (investigator rating) of breakthrough BEs, and 99% of surgical procedures (investigator rating). Conclusion wilate was safe, well tolerated, and effective for the prevention and treatment of bleeding in pediatric and adult VWD patients in a real-world setting.
- |||| Wilate (human factor VIII/von Willebrand factor) / Octapharma
New P3 trial: Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of Age (clinicaltrials.gov) - Jul 7, 2021
P3, N=12, Not yet recruiting, Sponsor: Octapharma
- Nuwiq (simoctocog alfa) / Octapharma
[VIRTUAL] New Insights into Prophylaxis with Simoctocog Alfa (Room 5) - Jul 3, 2021 - Abstract #ISTH2021ISTH_2903;
Conclusion wilate was safe, well tolerated, and effective for the prevention and treatment of bleeding in pediatric and adult VWD patients in a real-world setting. This session is supported by Octapharma AG
- | Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
Journal: Re-visiting the occurrence of mislabeling in frozen "pescada-branca" (Cynoscion leiarchus and Plagioscion squamosissimus - Sciaenidae) sold in Brazil using DNA barcoding and octaplex PCR assay. (Pubmed Central) - Jul 1, 2021
The multiplex assay constitutes a cost-effective alternative for the authentication of these products and other sciaenids. Additionally, we suggest that the multiplex assay can be adopted by both companies and regulatory agencies to prevent commercial fraud in the marketing of processed fishery products in Brazil and other countries where these products are commercialized.
- Octagam (intravenous normal human immunoglobulin) / Octapharma
Trial completion: Study of SOC Plus IVIG Compared to SOC Alone in the Treatment of COVID-19 (clinicaltrials.gov) - Jun 25, 2021
P4, N=34, Completed, Sponsor: George Sakoulas, MD
Additionally, we suggest that the multiplex assay can be adopted by both companies and regulatory agencies to prevent commercial fraud in the marketing of processed fishery products in Brazil and other countries where these products are commercialized. Active, not recruiting --> Completed
- || Wilate (human factor VIII/von Willebrand factor) / Octapharma
Enrollment closed: WIL-31: Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWD (clinicaltrials.gov) - Jun 25, 2021
P3, N=28, Active, not recruiting, Sponsor: Octapharma
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- |||| Panzyga (immune globulin intravenous, human-ifas) / Octapharma, Pfizer
New P3 trial: NGAM-11: Study to Evaluate Safety and Efficacy of Different PANZYGA Dose Regimens in Pediatric Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients (clinicaltrials.gov) - Jun 18, 2021
P3, N=30, Not yet recruiting, Sponsor: Octapharma
- Fibryga (fibrinogen concentrate (human)) / Octapharma
[VIRTUAL] Efficacy and Safety of Human Fibrinogen Concentrate for Treatment of on-demand Bleeding in Adolescent and Pediatric Patients with Congenital Fibrinogen Deficiency: Results from the FORMA-02 and FORMA-04 Clinical Trials (Room 1) - Jun 9, 2021 - Abstract #ISTH2021ISTH_2308;
Conclusions : Across two Phase 3 clinical trials, HFC was efficacious for on-demand BE treatment in adolescent and pediatric patients with CFD, which is comparable to adult patients with CFD. Hemostatic efficacy of HFC was comparable for adolescent and pediatric patients, with a favorable safety profile.
- Nuwiq (simoctocog alfa) / Octapharma
[VIRTUAL] Successful Immune Tolerance Induction with High Dose Simoctocog Alfa in Hemophilia A Adult Patient with High Responder Inhibitor: A Case Report (Room 4) - Jun 9, 2021 - Abstract #ISTH2021ISTH_1791;
At 18 months, a 72-h washout pharmacokinetic evaluation was conducted, showing 64% and 19.6% FVIII at 0.5 and 7hrs, respectively. Conclusions : Simoctocog alfa may be an effective option for hemophilia A adult patient with high-responder inhibitor and other unfavourable prognostic factors.
- Wilate (human factor VIII/von Willebrand factor) / Octapharma
[VIRTUAL] Plasma-derived VWF/FVIII Concentrate (wilate®) for Haemostasis in Women with VWD during Childbirth (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_1335;
Conclusions : Peripartum doses of wilate® aiming to increase VWF and FVIII levels in VWD patients can prevent excessive bleeding associated with childbirth. These results suggest that wilate® may be an effective treatment for management of bleeding in women with any type of VWD when giving birth.
- Fibryga (fibrinogen concentrate (human)) / Octapharma
[VIRTUAL] Safety and Efficacy of Fibrinogen Concentrate in Congenital Fibrinogen Deficiency: A Post-marketing Observational Study (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_1090;
Results will be monitored on an ongoing basis. Conclusions : Real-world evidence from routine clinical use will further assess the safety profile of HFC, supporting clinical study data on the use of this HFC for bleeding treatment in patients with congenital fibrinogen deficiency.
- Fibryga (fibrinogen concentrate (human)) / Octapharma
[VIRTUAL] Human Fibrinogen Concentrate for Bleeding Prophylaxis During Surgery in Adult, Adolescent and Pediatric Patients with Congenital Fibrinogen Deficiency: Results from the FORMA-02 and FORMA-04 Clinical Trials (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_1066;
No allergic/hypersensitivity reactions or deaths were observed. Conclusions : In conclusion, HFC administration for bleeding prophylaxis during minor/major surgery was efficacious for the ultra-rare CFD in adult, adolescent and pediatric patients.
- Fibryga (fibrinogen concentrate (human)) / Octapharma
[VIRTUAL] Efficacy and Safety of Human Fibrinogen Concentrate for Treatment of on-demand Bleeding in Adolescent and Pediatric Patients with Congenital Fibrinogen Deficiency: Results from the FORMA-02 and FORMA-04 Clinical Trials (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_1055;
Conclusions : Across two Phase 3 clinical trials, HFC was efficacious for on-demand BE treatment in adolescent and pediatric patients with CFD, which is comparable to adult patients with CFD. Hemostatic efficacy of HFC was comparable for adolescent and pediatric patients, with a favorable safety profile.
- Wilate (human factor VIII/von Willebrand factor) / Octapharma, Nuwiq (simoctocog alfa) / Octapharma, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
[VIRTUAL] PRactical Utilisation of Octapharma FVIII Concentrates in Previously Untreated and Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment with Nuwiq®, octanate® or wilate® – The Protect-NOW Study (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_987;
Results : As of March 2021, 37 patients have been enrolled in the study from 13 sites in Belarus, Canada, France, Germany, Italy, Lithuania, Spain and the United Kingdom, with additional sites to be initiated. Conclusions : Protect-NOW is collecting clinically relevant information on the outcomes of PUPs and MTPs treated with Octapharma‘s FVIII products in a real-world setting.
- Nuwiq (simoctocog alfa) / Octapharma
[VIRTUAL] Efficacy of Simoctocog Alfa in Previously Untreated Patients with Severe Haemophilia A: Final Results from the NuProtect Study (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_950;
Efficacy in surgical prophylaxis was rated as excellent or good in 94.7% (18/19) of procedures. Conclusions : Simoctocog alfa was efficacious for the prevention and treatment of BEs in PUPs with haemophilia A, including during surgery.
- Nuwiq (simoctocog alfa) / Octapharma
[VIRTUAL] Comparison of single-subject and population-based pharmacokinetics for individualising prophylaxis with simoctocog alfa in patients with haemophilia A (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_917;
Conclusions : Our data support the use of population-based PK to individualise simoctocog alfa prophylaxis regimens. The data indicate differences between the approaches, stressing the importance of monitoring the actual FVIII levels achieved irrespective of the approach used.
- Nuwiq (simoctocog alfa) / Octapharma
[VIRTUAL] Immunogenicity and Safety of Simoctocog Alfa in Previously Treated Patients Switching to Simoctocog Alfa in the GENA Clinical Trial Programme (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_909;
Only one (0.3%) patient had an AE (mild pyrexia that resolved) that was classified as serious because the patient was hospitalised. Conclusions : None of the 310 PTPs who switched to simoctocog alfa developed an inhibitor and very few treatment-related adverse occurred during extensive exposure.
- Nuwiq (simoctocog alfa) / Octapharma
[VIRTUAL] Long-term Prophylaxis with Simoctocog Alfa in Children (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_896;
None of the 96 patients on long-term prophylaxis withdrew from the studies due to an adverse event and there were no thrombotic events. Conclusions : Simoctocog alfa is efficacious and well-tolerated for long-term prophylaxis in children with severe haemophilia A and is an attractive long-term therapeutic option for children.
- Octanine (human plasma derived coagulation factor IX) / Octapharma
[VIRTUAL] Prospective, Open-label, Multicentre Phase II Study (PeKaFIX) to Evaluate the Pharmacokinetic Parameters of a Plasma Derived Factor IX Concentrate and Build a Pharmacokinetic Bayesian Model (Room 3) - Jun 9, 2021 - Abstract #ISTH2021ISTH_863;
Conclusions : OCTANINE® has a terminal half-life of 35 hours after a single administration. The FIX model enables sparse sampling data to be used to individualise OCTANINE® prophylaxis and suggests that some patients could be treated with less frequent injections to maintain a trough level above 1%.
- |||| Atenativ (human antithrombin III) / Octapharma
New P3 trial, Surgery: ATN-106: Efficacy of Atenativ in Patients with Congenital Antithrombin Deficiency Undergoing Surgery or Delivery (clinicaltrials.gov) - Jun 7, 2021
P3, N=34, Not yet recruiting, Sponsor: Octapharma
- Octagam (intravenous normal human immunoglobulin) / Octapharma
[VIRTUAL] Difficulty Monitoring Thyroid Cancer Recurrence With Thyroglobulin Antibody In Patients Receiving Immunoglobulin Therapy () - Jun 7, 2021 - Abstract #AACE2021AACE_362;
Immunoglobulin therapy such as Octagam , are sterile preparations of highly purified immunoglobulin G (IgG) derived from large pools of human plasma which leads to passive transfer of antibodies including anti-Tg antibody. Here we present two cases of patients with PTC on IVIG injections with fluctuating anti-Tg antibody levels, making monitoring extremely challenging.
- || Nuwiq (simoctocog alfa) / Octapharma, Octanate (human Factor VIII/von Willebrand Factor) / Octapharma
Clinical, Review, Journal: Personalised Prophylaxis in a Child with Haemophilia A and Type 1 Diabetes. (Pubmed Central) - Jun 3, 2021
rFVIII was well tolerated, with no treatment-related adverse events observed. This case illustrates the importance of treatment personalisation for young patients and their families managing concomitant diseases.
- Octagam (intravenous normal human immunoglobulin) / Octapharma
[VIRTUAL] A CLINICAL CASE OF X-LINKED HYPER-IGM SYNDROME () - Jun 2, 2021 - Abstract #ESPID2021ESPID_1432;
Against the background of the treatment (antibiotic therapy, octagam), a slight improvement in the condition of the boy was noted, however, after a short period of relief, complaints again appeared about fever, diarrhea, aphthous stomatitis, weight loss...The CD40LG gene is associated with X-linked hyper-IgM syndrome (HIGM). Learning Points/ Since primary immunodeficiency states can manifest themselves with malabsorption syndrome, diarrhea, IBD, pediatricians should be more alert and take into account in the differential diagnosis of these conditions and the choice of treatment regimens.
- | Journal: Quantitative HLA-class-II/Factor VIII (FVIII) Peptidomic Variation in Dendritic Cells Correlates with the Immunogenic Potential of Therapeutic FVIII Proteins in Hemophilia A. (Pubmed Central) - May 15, 2021
Learning Points/ Since primary immunodeficiency states can manifest themselves with malabsorption syndrome, diarrhea, IBD, pediatricians should be more alert and take into account in the differential diagnosis of these conditions and the choice of treatment regimens. Our results provide HLAcII peptidomic level explanations for several important clinical observations/issues including the differential immunogenicity of distinct FVIIIs and the role of HLAcII genetics in inhibitor development.
- || Fibryga (fibrinogen concentrate (human)) / Octapharma
Clinical, Journal: Fibrinogen concentrate for treatment of bleeding and surgical prophylaxis in congenital fibrinogen deficiency patients. (Pubmed Central) - May 15, 2021
Our results provide HLAcII peptidomic level explanations for several important clinical observations/issues including the differential immunogenicity of distinct FVIIIs and the role of HLAcII genetics in inhibitor development. HFC was efficacious for on-demand treatment of bleeding and as surgical prophylaxis, with a favorable safety profile, in patients with congenital afibrinogenemia.
- Octagam (intravenous normal human immunoglobulin) / Octapharma, Zarzio (filgrastim biosimilar) / Novartis
[VIRTUAL] PROSID STUDY: EVALUATING EFFICACY AND SAFETY OF INTRAVENOUS IMMUNOGLOBULIN (IVIG) 10% IN PRIMARY INFECTION PROPHYLAXIS IN PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA – STUDY DESIGN () - May 13, 2021 - Abstract #EHA2021EHA_1282;
Results Interim analysis will be conducted once at least 100 patients are available for evaluation of the primary endpoint in the ITT population). Conclusion This study will evaluate the efficacy and safety of IVIg 10% as primary prophylaxis of infections inCLL patients with SID in a large clinical setting for the first time.
- ||| Fibryga (fibrinogen concentrate (human)) / Octapharma
Trial completion, Real-world evidence, Real-world: Use of Fibryga, a Fibrinogen Concentrate in Real World: Retrospective Collection of Clinical Data (clinicaltrials.gov) - May 12, 2021
P=N/A, N=200, Completed, Sponsor: Octapharma
Conclusion This study will evaluate the efficacy and safety of IVIg 10% as primary prophylaxis of infections inCLL patients with SID in a large clinical setting for the first time. Recruiting --> Completed
- Kcentra (plasma-derived prothrombin complex concentrate) / CSL Behring, Octaplex (human prothrombin complex concentrate) / Octapharma, Pfizer
[VIRTUAL] Reversal of anticoagulation with PCC – every minute counts () - May 12, 2021 - Abstract #BSH2021BSH_467;
Lack of knowledge about PCC by staff treating these emergency cases and delays caused by patient transfers are avoidable. Every effort must be made to improve local systems and reduce the ‘door to needle’ time for administering PCC in these patients.
- ||| Gammanorm (human immune globulin subcutaneous) / Octapharma
Trial completion date, Trial primary completion date: Study to Monitor Subcutaneous Human Immunoglobulin Administered at Modified Dosing Regimens in Patients With Primary Immunodeficiency Diseases (clinicaltrials.gov) - May 12, 2021
P3, N=65, Recruiting, Sponsor: Octapharma
Every effort must be made to improve local systems and reduce the ‘door to needle’ time for administering PCC in these patients. Trial completion date: Mar 2021 --> Jul 2021 | Trial primary completion date: Mar 2021 --> Jul 2021
- |||||||| Balfaxar (prothrombin complex concentrate, human-lans) / Octapharma, Pfizer
New P3 trial: LEX-210: Study of OCTAPLEX in Patients With Acute Major Bleeding on DOAC Therapy With Factor Xa Inhibitor (clinicaltrials.gov) - Apr 29, 2021
P3, N=200, Not yet recruiting, Sponsor: Octapharma
- ||| Hemlibra (emicizumab-kxwh) / Roche, Nuwiq (simoctocog alfa) / Octapharma
Trial completion date, Trial primary completion date: The Atlanta Study: Emicizumab PUPs and Nuwiq ITI Study (clinicaltrials.gov) - Apr 28, 2021
P3, N=60, Not yet recruiting, Sponsor: Emory University
Trial completion date: Mar 2021 --> Jul 2021 | Trial primary completion date: Mar 2021 --> Jul 2021 Trial completion date: Oct 2024 --> Apr 2025 | Trial primary completion date: Oct 2024 --> Apr 2025