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

B

Bioverativ

Status and phase

Completed
Phase 1

Conditions

Severe Hemophilia A

Treatments

Drug: rFVIIIFc

Study type

Interventional

Funder types

Industry

Identifiers

NCT01027377
998HA101

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

Male

Ages

12+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

16 participants in 2 patient groups

A
Experimental group
Description:
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
Treatment:
Drug: rFVIIIFc
B
Experimental group
Description:
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
Treatment:
Drug: rFVIIIFc

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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