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

December 16, 2020 updated by: Bioverativ Therapeutics Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Research Site
  • Israel
      • Tel Aviv, Israel
        • Research Site
  • United States
    • California
      • Los Angeles, California, United States
        • Research Site
      • Sacramento, California, United States
        • Research Site
    • Massachusetts
      • Waltham, Massachusetts, United States
        • Research Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • Washington
      • Seattle, Washington, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Cohort to receive a single low dose intravenous injection of commercially available rFVIII with safety and PK assessments followed by a single low dose intravenous injection of rFVIIIFc with safety and PK assessments
Drug: rFVIIIFc
Single dose
Other Names:
  • Recombinant Factor VIII fusion protein
EXPERIMENTAL: B
Cohort to receive a single high dose intravenous injection of commercially available rFVIII with safety and PK assessments followed by a single high dose intravenous injection of rFVIIIFc with safety and PK assessments
Drug: rFVIIIFc
Single dose
Other Names:
  • Recombinant Factor VIII fusion protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
78 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
78 weeks
To determine the pharmacokinetics parameters after single administration of 25 and 65 IU/kg of rFVIIFc compared to advate
Time Frame: 78 weeks
78 weeks
To determine the pharmacodynamic activity of FVIII over time for both doses of rFVIIIFc
Time Frame: 78 weeks
78 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioverativ Therapeutics Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

December 4, 2009

First Submitted That Met QC Criteria

December 4, 2009

First Posted (ESTIMATE)

December 7, 2009

Study Record Updates

Last Update Posted (ACTUAL)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 998HA101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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