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Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A

NCT00289536 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-06-10

Study results available
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Summary

The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial recovery (% increase \[IU/dL\] per IU/kg infused) and major single-infusion pharmacokinetic parameters. The 3 doses are 15, 30, and 50 IU/kg. Prior to each infusion, subjects will not have received treatment with a factor VIII concentrate for at least 3 days. Blood samples will be drawn within 30 minutes pre-infusion and at 0.25, 0.5, 1, 3, 6, 9, 24, 28, 32 and 48 hours post-infusion. A washout period of at least 3 days, but no more than 30 days between the last blood draw and the next infusion will be observed. During participation, subjects will maintain their preexisting treatment regimens with ADVATE rAHF-PFM or other factor VIII concentrate.

A secondary objective is to investigate the relationship between pharmacokinetic parameters at each dose level and the levels of von Willebrand factor ristocetin cofactor activity and von Willebrand factor antigen at baseline.

Conditions

Interventions

BIOLOGICAL

Antihemophilic factor, recombinant, manufactured protein-free

15 IU/kg rAHF-PFM

BIOLOGICAL

Antihemophilic factor, recombinant, manufactured protein-free

30 IU/kg rAHF-PFM

BIOLOGICAL

Antihemophilic factor, recombinant, manufactured protein-free

50 IU/kg rAHF-PFM

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-02
Primary Completion
2007-04-01
Completion
2007-04-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00289536 on ClinicalTrials.gov