Clinical trials: Factor VIII Deficiency
Factor VIII Deficiency
A Phase 3 Open-label Interventional Study of Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein, Efanesoctocog Alfa (BIVV001), in Patients With Severe Hemophilia A
Primary Objective: To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm. Secondary Objectives: To evaluate the efficacy of BIVV001 as a prophylaxis treatment.
- Trial name
- XTEND-1 (NCT04161495)
- Testing
- efanesoctocog alfa (BIVV001)
- Where
- 47 sites in United States, Argentina and 17 more
- Volunteers
- 159 people
- Sponsor
- Bioverativ, a Sanofi company
Hemophilia A, Hemophilia A, Severe
Hemophilia A Research Program
This study longitudinally observes the intergenerational (mother-child) continuum in hemophilia A from pregnancy through early childhood.
- Conditions
- Hemophilia A, Hemophilia A, Severe, Factor VIII (FVIII), FVIII Deficiency
- Trial name
- HARP (NCT07414511)
- Where
- United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- University of Washington
Congenital Bleeding Disorder, Haemophilia A
A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A
Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A
- Trial name
- pathfinder™7 (NCT02920398)
- Testing
- turoctocog alfa pegol
- Where
- 14 sites in United States, Denmark and 4 more
- Volunteers
- 21 people
- Sponsor
- Novo Nordisk A/S
Haemophilia A, Haemophilia B
Post-Marketing Surveillance (All Case Surveillance) on Treatment With Alhemo® in Patients With Haemophilia A or Haemophilia B With Inhibitors
The purpose of the study is to investigate the safety and effectiveness of Alhemo® in all participants under real-world clinical practice in Japan. Participants will get Alhemo® as prescribed by the study doctor.
- Trial name
- NCT06285071
- Testing
- Concizumab
- Where
- 11 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Novo Nordisk A/S
Hemophilia, AIDS
Host Genetic Factors Influencing HIV1 and HCV Viral Loads and AIDS Clinical Progression in a Hemophilia Cohort (HGDS-3)
Background: Over 80% of the hemophiliac population who became infected with HIV prior to 1985 are also co-infected with HCV. Thus, hemophiliacs represent an important population for studies of the natural history of these chronic…
- Trial name
- NCT00340548
- Where
- 15 sites in United States
- Volunteers
- 333 people
- Sponsor
- National Cancer Institute (NCI)
Hemophilia A, Factor VIII
Personalized Prophylactic Treatment With Advate® in Severe or Moderate Haemophilia A Patients
Haemophilia A is an inherited bleeding disorder caused by a deficiency of factor VIII (FVIII). Patients with severe hemophilia A have a FVIII plasma concentration less than1 IU/dL and experience spontaneous and trauma-induced…
- Trial name
- NCT02622646
- Testing
- Recombinant VIII factor
- Where
- Spain
- Volunteers
- 25 people
- Sponsor
- Hospital Universitario La Fe
Hemophilia A With Inhibitor
rFVIIIFc (Elocta®) ITI Chart Review in Patients With Haemophilia A
A chart review study of patients with haemophilia A with inhibitors treated with rFVIIIFc (Elocta®) for immune tolerance induction.
- Trial name
- NCT03951103
- Testing
- rFVIIIFc
- Where
- 18 sites in France, Germany and 6 more
- Volunteers
- 44 people
- Sponsor
- Swedish Orphan Biovitrum
Congenital Bleeding Disorder, Haemophilia A
Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period
This study will test the well-known medicine turoctocog alfa for any side effects. The purpose is to test turoctocog alfa for any side effects in the Indian population. The participants will get turoctocog alfa.
- Trial name
- guardian 10 (NCT03449342)
- Testing
- turoctocog alfa
- Where
- 9 sites in India
- Volunteers
- 60 people
- Sponsor
- Novo Nordisk A/S
HIV Infections, Hemophilia A
The Effects of AZT and Ibuprofen on HIV-Infected Patients With Hemophilia
To determine if platelet dysfunction and/or pharmacologic drug interaction occurs in patients taking both AZT and ibuprofen, which might account for enhanced bleeding tendency.
- Trial name
- NCT00002276
- Testing
- Ibuprofen, Zidovudine
- Where
- United States
- Sponsor
- University of Pittsburgh
Hemophilia A
Non-interventional Observation of Practical Implementation, Efficacy and Safety of Continuous Infusion With KOGENATE Bayer in Surgery
The objective of this international post-marketing surveillance study is to collect data on the efficacy and safety of continuous infusion with KOGENATE Bayer in surgery.
- Trial name
- NO PEACKS (NCT00922597)
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 7 sites in Austria, Germany and 5 more
- Volunteers
- 26 people
- Sponsor
- Bayer
Hemophilia A
Safety/Efficacy Study to Assess Whether FVIII/VWF Concentrate Can Induce Immune Tolerance in Haemophilia A Patients
The purpose of this study is to assess the role of a FVIII/VWF complex concentrate (Emoclot) in successfully inducing immune tolerance (I.T.I.) in patients with Haemophilia A with inhibitors, including patients at high risk of…
- Trial name
- ITI (NCT02479087)
- Testing
- Plasma-derived FVIII/VWF concentrate
- Where
- 4 sites in Egypt, India
- Volunteers
- 20 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Severe Hemophilia A
Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs)
The purpose of the study is to study the long-term efficacy, safety and tolerability of Human-cl rhFVIII in previously treated patients with severe hemophilia A.
- Trial name
- NCT01341912
- Testing
- Human-cl rhFVIII
- Where
- 2 sites in United States, Bulgaria
- Volunteers
- 3 people
- Sponsor
- Octapharma
Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1
Baby Detect : Genomic Newborn Screening
Newborn screening (NBS) is a global initiative of systematic testing at birth to identify babies with pre-defined severe but treatable conditions.
- Conditions
- Congenital Adrenal Hyperplasia, Familial Hyperinsulinemic Hypoglycemia 1, Phosphoglucomutase 1 Deficiency, Maturity Onset Diabetes of the Young
- Trial name
- BabyDetect (NCT05687474)
- Where
- Belgium
- Volunteers
- 6,824 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Liege
Hemophilia A Without Inhibitor, Hemophilia B Without Inhibitor
Efficacy and Safety of KN057 Prophylaxis in Patients With Haemophilia A or B Without Inhibitors
The purpose of this study is to show that KN057 can prevent bleeds in patients with haemophilia A or B without inhibitors and is safe to use.
- Trial name
- NCT06569108
- Testing
- KN057
- Where
- China
- Volunteers
- 125 people
- Sponsor
- Suzhou Alphamab Co., Ltd.
Haemophilia A
Validation Study of a cOmputer Pharmacokinetic Tool to assIst in the Follow up Care of haeMophilia A Patients
OPTIMS is a non interventional validation study of the calculator developed by Bayer for clinician's use in the prophylactic treatment by factor VIII of patients with severe or moderate Haemophilia A with a severe clinical…
- Trial name
- OPTIMS (NCT01436825)
- Testing
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Where
- 2 sites in France, Italy
- Volunteers
- 69 people
- Sponsor
- Bayer
Hemophilia A
Safety and Efficacy of BAY94-9027 in Previously Treated Male Children With Haemophilia A
Hemophilia A is an inherited blood disorder in which one protein, Factor VIII, needed to form blood clots is missing or not present in sufficient levels.
- Trial name
- NCT01775618
- Testing
- BAY94-9027
- Where
- 37 sites in United States, Argentina and 15 more
- Volunteers
- 73 people
- Sponsor
- Bayer
Haemophilia A, Factor VIII
Study of Surgical Practices in Hemophilia A Patients Treated With Efanesoctocog Alfa (Altuvoct®)
Hemophilia A is an inherited bleeding disorder caused by the absence or deficiency of coagulation factor VIII. The perioperative management of individuals with hemophilia A involves replacement therapies, typically through bolus…
- Trial name
- CHALE II (NCT07723560)
- Testing
- Clinical Data
- Where
- France
- Volunteers
- 160 people
- Sponsor
- Hospices Civils de Lyon
Severe Hemophilia A With Inhibitor
Thrombin Generation Assay (TGA) as Predictive Test for Haemostatic. Effectiveness of FVIII Concentrates in Haemophiliac A With Inhibitors
This is an observational, prospective, longitudinal, multicenter, cohort study designed with the scope to verify whether or not TGA may predict effectiveness of different FVIII concentrates class (devoid or rich of VWF) in…
- Trial name
- PredicTGA (NCT01505946)
- Testing
- TGA (Thrombin generation Assay)
- Where
- 15 sites in Italy
- Volunteers
- 25 people
- Sponsor
- Grifols Italia S.p.A
Hemophilia A
Individually Tailored Prophylaxis in Patients With Severe Hemophilia A
Patients with severe haemophilia A lack clotting factor FVIII and suffer from spontaneous and traumatic bleeds. In the absence of treatment, frequent bleeds in joints lead to severe joint destruction.
- Trial name
- OPTIPHASE (NCT00995046)
- Testing
- FVIII
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Hospices Civils de Lyon
Acquired Immunodeficiency Syndrome, HIV Infections
Prospective Study of HIV Infection in Hemophiliacs
To examine mechanisms of individual differences in the progression of HIV infection in hemophiliacs.
- Conditions
- Acquired Immunodeficiency Syndrome, HIV Infections, Blood Disease, Hemophilia A
- Trial name
- NCT00005309
- Sponsor
- Bloodworks