Clinical trials: Hemophilia B
Hemophilia A, Hemophilia B
Understanding Hemophilia A and B Drug Dosage Administration Patterns
Study Design A prospective observational, cross-sectional epidemiological study in U.S. site-based clinical practice settings. 30 sites will enroll approximately 300 patients Participating patients - or their caregiver in the…
- Trial name
- NCT03248141
- Testing
- Hemophilia B standard half-life, Hemophilia B extended half-life, Hemophilia A standard half-life
- Where
- 3 sites in United States
- Volunteers
- 11 people
- Sponsor
- Pfizer
Acquired Hemophilia A
Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A
This study is to test whether the study drug (OBI-1) is safe and effective for the treatment of serious bleeding episodes in people with acquired hemophilia A.
- Trial name
- NCT01178294
- Testing
- OBI-1
- Where
- 12 sites in United States, Canada and 2 more
- Volunteers
- 29 people
- Sponsor
- Baxalta now part of Shire
Hemophilia
Are There Differences Between Carriers of Haemophilia A and B?
This study aims to develop a systematic genetic screening strategy for (potential) female carriers of haemophilia by identifying as many female carriers as possible within the families of haemophilia patients regularly followed…
- Trial name
- NCT05217992
- Testing
- Genetic assessment (hemophilia testing)
- Where
- Belgium
- Volunteers
- 900 people, healthy volunteers welcome
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Haemophilia B
Observatory of Patients With Haemophilia B Treated by IdElvion®
OrPHEe is a non-interventional, prospective and national study which aim is to record real life data in haemophilia B French patients treated with Idelvion® to confirm the efficacy and safety of this product established in…
- Trial name
- OrPHEe (NCT05086575)
- Where
- 28 sites in France
- Volunteers
- 222 people
- Sponsor
- CSL Behring
Hemophilia B
Evaluation of a Recombinant Factor IX Product, APVO101, in Previously-Treated Pediatric Patients With Hemophilia B
Phase 3/4, single arm, open-label study to evaluate PK, safety, and efficacy of APVO101 prophylaxis in severe or moderately severe hemophilia B subjects < 12 years of age.
- Trial name
- NCT03855280
- Testing
- APVO101
- Where
- 11 sites in Brazil, Georgia and 4 more
- Volunteers
- 21 people
- Sponsor
- Medexus Pharma, Inc.
Hemophilia A, Hemophilia B
Virtual Reality for Hemophilia
Children with hemophilia are exposed to intravenous (IV) procedures that cause pain/anxiety and distraction methods can be employed to improve the patient experience.
- Trial name
- NCT03507582
- Testing
- Virtual Reality Distraction, Standard of Care Distraction
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Nationwide Children's Hospital
Hemophilia B
A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) in Pediatric, Adolescent and Adult Participants With Hemophilia B
Participants in this study have a genetic mutation, specifically in the coagulation (blood clotting) Factor 9 gene that causes severe or moderately severe hemophilia B.
- Trial name
- BEYOND-9 (NCT06379789)
- Testing
- REGV131, LNP1265
- Where
- 52 sites in United States, Australia and 7 more
- Volunteers
- 130 people
- Sponsor
- Regeneron Pharmaceuticals
Hemophilia B
Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or Moderately Severe Hemophilia B
This is a phase 3, prospective, open-label, single-arm, single-dose, multicenter study investigating the efficacy, safety, and tolerability of CSL222 (AAV5-hFIXco-Padua) in adolescent male participants with severe or moderately…
- Trial name
- IX-TEND 3004 (NCT07080905)
- Testing
- CSL222 (Adeno-associated viral vector serotype 5 [AAV5]-hFIXco-Padua)
- Where
- 17 sites in United States, Australia and 6 more
- Volunteers
- 20 people
- Sponsor
- CSL Behring
Congenital Bleeding Disorder, Haemophilia B
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP)…
- Trial name
- paradigm™5 (NCT01467427)
- Testing
- nonacog beta pegol
- Where
- 51 sites in United States, Brazil and 10 more
- Volunteers
- 25 people
- Sponsor
- Novo Nordisk A/S
Cardiac Valve Disease
Prothrombin Complex Concentrate vs Fresh Frozen Plasma in Goal-directed Bleeding Management in Cardiac Surgery
The primary endpoint of this study is the completion time of hemostasis treatment when administered Fresh frozen plasma (FFP) and frozen powder coagulation factor concentrate (PCC) in goal-directed bleeding management for cardiac…
- Trial name
- NCT06144125
- Testing
- fresh frozen plasma, prothrombin complex concentrate
- Where
- South Korea
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Konkuk University Medical Center
Hemophilia A
Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A
The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate…
- Trial name
- NCT00141843
- Testing
- ReFacto AF, B-Domain deleted Recombinant Factor VIII, BDDrFVIII
- Where
- 41 sites in United States, Australia and 11 more
- Volunteers
- 100 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Congenital Bleeding Disorder, Haemophilia A With Inhibitors
Non-Interventional Study of NovoSeven® Used as On-demand Treatment of Bleeds in Patients With Haemophilia A and B With Inhibitors
This study is conducted in Japan. The aim of this registry study is to observe the use of single dose and multi-dose use of eptacog alpha (NovoSeven®) and to compare short-term outcomes, including effectiveness, safety, quality…
- Conditions
- Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
- Trial name
- NCT01586936
- Testing
- eptacog alfa (activated)
- Where
- Japan
- Volunteers
- 9 people
- Sponsor
- Novo Nordisk A/S
Septic Shock, Sepsis
Effects of Anisodamine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock
This prospective, multicenter, single-arm, open-label interventional pilot study aims to evaluate the short-term physiological effects of intravenous anisodamine on sublingual microcirculation and vascular-waterfall parameters in…
- Conditions
- Septic Shock, Sepsis, Critical Illness
- Trial name
- ANISO-MICRO (NCT07657702)
- Testing
- Anisodamine intravenous infusion
- Where
- China
- Volunteers
- 20 people
- Sponsor
- First Affiliated Hospital of Wannan Medical College
Hemophilia B
Gene Therapy for Chinese Hemophilia B
GT2019001 is a Phase 1, open- label, non- randomized, uncontrolled, single dose pilot study to evaluate the safety, tolerability and kinetics of a single intravenous infusion of BBM-H901 in hemophilia B subjects with ≤2IU/dl…
- Trial name
- NCT04135300
- Testing
- Single dose intravenous injection of BBM-H901
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Hemophilia
A Safety and Efficacy Study of STSP-0601 in Adult Patients With Hemophilia A or B With Inhibitor
This study will assess the safety and efficacy of multiple-dose of STSP-0601 for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors.
- Trial name
- NCT05027230
- Testing
- STSP-0601 for Injection
- Where
- China
- Volunteers
- 77 people
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
Hemophilia A
Study of Recombinant Porcine Factor VIII (FVIII) in Hemophilia and Inhibitors to FVIII
The ability of a new recombinant porcine coagulation factor VIII, B-domain deleted (called "OBI-1"), to control the non-life- or limb-threatening bleeding episodes patients with hemophilia A commonly develop is being evaluated.
- Trial name
- NCT00245245
- Testing
- recombinant porcine coagulation factor VIII (OBI-1)
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Octagen Corporation
Hemophilia A or B
A Study to Describe Patient REal-world FitusiRan ExpeRience
This is a real-world, mixed-methods observational study conducted among adolescent (ages 12-17 years) and adult participants diagnosed with hemophilia A or B, with or without Factor VIII (FVIII) or Factor IX (FIX) inhibitors, who…
- Trial name
- PREFER (NCT07895381)
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Sanofi
Hemophilia B
Study of Recombinant Coagulation Factor IX Fc Fusion Protein, BIIB029, in Previously Treated Pediatric Participants With Hemophilia B
The primary objective of the study is to evaluate the safety of Recombinant Human Coagulation Factor IX Fc Fusion Protein (rFIXFc) in previously treated pediatric subjects with hemophilia B.
- Trial name
- Kids B-LONG (NCT01440946)
- Testing
- rFIXFc, FIX
- Where
- 15 sites in United States, Australia and 4 more
- Volunteers
- 30 people
- Sponsor
- Bioverativ Therapeutics Inc.
Hemophilia B
Gene Therapy for Hemophilia B Patients Aged 12-18 Years Old
This is a Phase 1, open- label, non- randomized, uncontrolled, single dose pilot study to evaluate the safety, tolerability and efficacy of a single intravenous infusion of BBM-H901 in hemophilia B subjects with ≤2IU/dl residual…
- Trial name
- NCT05709288
- Testing
- BBM-H901
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Hemophilia A, Hemophilia B
Web Accessible Population Pharmacokinetics Service - Hemophilia: Sources of Variability
Using anonymized patient data collected as part of the WAPPS-Hemo project to explore the sources of variability in individual pharmacokinetics (PK); use the sources of variability to improve the performance of the WAPPS-Hemo…
- Trial name
- WAPPS-Hemo (NCT03533504)
- Testing
- Variability in individual PK
- Where
- Canada
- Volunteers
- 1,000 people
- Sponsor
- McMaster University