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NCT01027377 Clinical Trial

Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A

Severe Hemophilia A Clinical Trial

Official title:
An Open-Label, Crossover, Dose-Escalation, and Multi-Center Study to Determine the Safety, Tolerability, and Pharmacokinetic of a Single Intravenous Injection of rFVIIIFc in Previously Treated Patients With Severe Hemophilia A

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01027377
Other study ID # 998HA101
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date December 2009
Est. completion date May 2011

Study information
Verified date August 2018
Source Sanofi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is to investigate the safety, tolerability, and pharmacokinetics (the determination of the concentration of the administered drug in blood over time) of recombinant Factor VIII Fc fusion protein (rFVIIIFc) in previously-treated subjects with severe hemophilia A.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date May 2011
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Male
Age group 12 Years and older
Eligibility Inclusion Criteria: 1. Male and 12 years of age and older and weigh at least 40 kg 2. Diagnosed with severe hemophilia A (baseline Factor VIII level less than 1%) 3. History of at least 100 exposure days to any Factor VIII product Exclusion Criteria: 1. History of Factor VIII inhibitors 2. Kidney or liver dysfunction 3. Diagnosed with another coagulation defect other than hemophilia A

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• rFVIIIFc
Single dose
• rFVIIIFc
Single dose

Locations
Country Name City State
Hong Kong Research Site Hong Kong
Israel Research Site Tel Aviv
United States Research Site Los Angeles California
United States Research Site Pittsburgh Pennsylvania
United States Research Site Sacramento California
United States Research Site Seattle Washington
United States Research Site Waltham Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Bioverativ Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Hong Kong,  Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety will be assessed by physical examination, vital signs, laboratory changes overtime, adverse events, and assessment of inhibitor (Bethesda) and antibody development against rFVIIIFc. 78 weeks
Secondary Pharmacokinetic parameters will be measured such as, but not limited to Tmax, Cmax, t1/2, CL, Vd, AUC, MRT, and incremental recovery. 78 weeks
Secondary To determine the pharmacokinetics parameters after single administration of 25 and 65 IU/kg of rFVIIFc compared to advate 78 weeks
Secondary To determine the pharmacodynamic activity of FVIII over time for both doses of rFVIIIFc 78 weeks
See also
  Status Clinical Trial Phase
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Completed NCT02172950 - An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A Phase 3
Completed NCT01051076 - Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced) N/A
Completed NCT03376516 - Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Paediatric Patients With Severe Haemophilia A Phase 3
Completed NCT01181128 - Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A Phase 3
Not yet recruiting NCT06136507 - Study of Efficacy and Safety of FRSW107 in Pediatric Patients With Severe Hemophilia A Phase 3
Completed NCT02083965 - Pharmacokinetics of rFVIIIFc at Two Vial Strengths Phase 1
Completed NCT01085344 - Canadian Hemophilia Prophylaxis Study Phase 4
Completed NCT04864743 - A Study to Evaluate the Pharmacokinetics，Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection Phase 1
Completed NCT01341912 - Study to Investigate the Long-term Efficacy and Safety of Human-cl rhFVIII in Previously Treated Patients (PTPs) Phase 3
Completed NCT01125813 - Efficacy and Safety Study of Human-cl rhFVIII in PTPs With Severe Hemophilia A Phase 3
Active, not recruiting NCT05181618 - A Study to Evaluate Overall Health, Physical Activity, and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis Phase 4
Terminated NCT04046848 - Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A Phase 1/Phase 2
Completed NCT06137092 - rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study Phase 3
Terminated NCT01405742 - Hemophilia Adult Prophylaxis Study Phase 3
Active, not recruiting NCT04431726 - A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Emicizumab in Participants From Birth to 12 Months of Age With Hemophilia A Without Inhibitors Phase 3
Recruiting NCT05935358 - Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study Phase 4
Completed NCT01712438 - Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients Phase 3
Recruiting NCT06142552 - Phase 3 Clinical Project of Pegylated Recombinant Human Coagulation Factor VIII-Fc Fusion Protein Phase 3
Completed NCT02954575 - Clinical Study to Investigate the PK, Efficacy, and Safety of Wilate in Patients With Severe Hemophilia A Phase 3