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Completed

NCT Number: NCT01027377

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

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.

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Key information

Conditions

Severe Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

12 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male and 12 years of age and older and weigh at least 40 kg
  • Diagnosed with severe hemophilia A (baseline Factor VIII level less than 1%)
  • History of at least 100 exposure days to any Factor VIII product

Exclusion criteria

  • History of Factor VIII inhibitors
  • Kidney or liver dysfunction
  • Diagnosed with another coagulation defect other than hemophilia A

Treatment and study plan

rFVIIIFc

Drug

Single dose

Other names: Recombinant Factor VIII fusion protein

Primary outcomes

  1. Safety will be assessed by physical examination, vital signs, laboratory changes overtime, adverse events, and assessment of inhibitor (Bethesda) and antibody development against rFVIIIFc.

    Time frame: 78 weeks

Secondary outcomes

  1. Pharmacokinetic parameters will be measured such as, but not limited to Tmax, Cmax, t1/2, CL, Vd, AUC, MRT, and incremental recovery.

    Time frame: 78 weeks

  2. To determine the pharmacokinetics parameters after single administration of 25 and 65 IU/kg of rFVIIFc compared to advate

    Time frame: 78 weeks

  3. To determine the pharmacodynamic activity of FVIII over time for both doses of rFVIIIFc

    Time frame: 78 weeks

Sponsors and collaborators

Lead sponsor

Bioverativ Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Dec 7, 2009
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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