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

NCT ID: NCT01027377

Last Updated: 2020-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Hemophilia A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

rFVIIIFc

Intervention Type DRUG

Single dose

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

Group Type EXPERIMENTAL

rFVIIIFc

Intervention Type DRUG

Single dose

Interventions

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rFVIIIFc

Single dose

Intervention Type DRUG

rFVIIIFc

Single dose

Intervention Type DRUG

Other Intervention Names

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Recombinant Factor VIII fusion protein Recombinant Factor VIII fusion protein

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bioverativ Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Los Angeles, California, United States

Site Status

Research Site

Sacramento, California, United States

Site Status

Research Site

Waltham, Massachusetts, United States

Site Status

Research Site

Pittsburgh, Pennsylvania, United States

Site Status

Research Site

Seattle, Washington, United States

Site Status

Research Site

Hong Kong, , Hong Kong

Site Status

Research Site

Tel Aviv, , Israel

Site Status

Countries

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China United States Hong Kong Israel

References

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Katragadda S, Neelakantan S, Diao L, Wong N. Population Pharmacokinetic Analysis of Recombinant Factor VIII Fc Fusion Protein in Subjects With Severe Hemophilia A: Expanded to Include Pediatric Subjects. J Clin Pharmacol. 2021 Jul;61(7):889-900. doi: 10.1002/jcph.1854. Epub 2021 Apr 14.

Reference Type DERIVED
PMID: 33719084 (View on PubMed)

Powell JS, Josephson NC, Quon D, Ragni MV, Cheng G, Li E, Jiang H, Li L, Dumont JA, Goyal J, Zhang X, Sommer J, McCue J, Barbetti M, Luk A, Pierce GF. Safety and prolonged activity of recombinant factor VIII Fc fusion protein in hemophilia A patients. Blood. 2012 Mar 29;119(13):3031-7. doi: 10.1182/blood-2011-09-382846. Epub 2012 Jan 5.

Reference Type DERIVED
PMID: 22223821 (View on PubMed)

Other Identifiers

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998HA101

Identifier Type: -

Identifier Source: org_study_id