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Pharmacokinetics of rFVIIIFc at Two Vial Strengths | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Pharmacokinetics of rFVIIIFc at Two Vial Strengths

A Randomized, Open-Label, Crossover Study to Evaluate the Pharmacokinetics of 2 Vial Strengths of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in Previously Treated Subjects With Severe Hemophilia A

NCT02083965•Bioverativ Therapeutics Inc.

View on ClinicalTrials.gov

Summary

The primary objective of the study is to characterize the pharmacokinetics (PK) of rFVIIIFc administered at vial strengths of 1000 and 3000 IU in subjects with severe hemophilia A. The secondary objective of the study is to evaluate the safety of rFVIIIFc beyond the PK assessment for up to 6 months for a continued treatment period.

Detailed Description

This is a randomized, open-label, crossover study during which each participant receives a single injection of rFVIIIFc from 2 different vial concentrations (PK assessment). After the PK assessment, participants are provided with rFVIIIFc for either prophylactic or episodic (on-demand) treatment for up to 6 months.

Eligibility

Age

12 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Have severe hemophilia A
•Previously treated subject, defined as having at least 150 documented prior exposure days to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products (other than any use of rFVIIIFc- study drug or commercial product) at Day 1. Fresh frozen plasma treatment must not be considered in the count for documented exposure days.
•No history of a positive inhibitor test or clinical signs of decreased response to FVIII administrations. Family history of inhibitors will not exclude subjects.
•No measurable inhibitor activity using the Nijmegen-modified Bethesda assay at Screening.
•Platelet count ≥100,000 platelets/μL at screening
•CD4 lymphocytes \>200 mm3 if known as HIV antibody positive at screening.
•Viral load of \<400 copies/mL if known HIV antibody positive at screening.

Exclusion Criteria

•Subject is at high risk of bleeding during the 5-day period between the first and second injections for PK analyses, as per Investigator discretion.
•Previous treatment with rFVIIIFc as study drug or commercial product.
•Other coagulation disorder(s) in addition to hemophilia A.
•History of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration.
•Currently taking (or likely to require during the study) acetylsalicylic acid (ASA), except for low-dose ASA as prophylaxis (other nonsteroidal anti-inflammatory drugs are permitted).
•Concurrent systemic treatment with immunosuppressive drugs within 12 weeks prior to Day 1. Exceptions to this include: ribavirin for treatment of hepatitis C virus (HCV), and/or systemic steroids (a total of 2 courses of pulse treatments lasting no more than 7 days at a dose of ≤1 mg/kg within 12 weeks prior to Day 1) and/or inhaled steroids.

Locations (8)

Research Site

Los Angeles, California, United States

Research Site

Salt Lake City, Utah, United States

Research Site

Seattle, Washington, United States

Research Site

Herston, Australia

Research Site

Perth, Australia

Research Site

Basingstoke, United Kingdom

Research Site

Cambridge, United Kingdom

Research Site

London, United Kingdom

Key Dates

Start Date

March 1, 2014

Primary Completion Date

October 1, 2014

Completion Date

May 1, 2015

Last Updated

December 19, 2020

Enrollment

ACTUAL participants

Conditions

Severe Hemophilia A

Interventions

rFVIIIFc

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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