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NCT00157053 · ClinicalTrials.gov registry record · Phase 2

Study of Pharmacokinetics, Efficacy and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients - A Continuation of Clinical Study 069901

A Phase 2 study, sponsored by Baxalta now part of Shire.

Completed
Registry status
Phase 2
Development phase
82
Enrollment target

NCT00157053: Completed Phase 2 study, sponsored by Baxalta now part of Shire.

NCT00157053 is a Phase 2 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00157053, a Phase 2 study, has completed, sponsored by Baxalta now part of Shire.

COMPLETED
Registry status
Phase 2
Development phase
82 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, and Part 2 is an evaluation of efficacy and safety. The study is open to patients who completed Baxter Study 069901.

Interventions

  • DRUG Antihemophilic factor, recombinant, manufactured protein-free

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2001-11-22
Est. Completion 2004-08-03
Phase Phase 2
Baxalta now part of Shire

74 total trials

What the finished NCT00157053 record still lists

NCT00157053 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).

The record links to 0 conditions, and to 1 intervention - of which Antihemophilic factor, recombinant, manufactured protein-free is the first listed.

NCT00157053 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00157053 about?

NCT00157053 is a clinical study titled "Study of Pharmacokinetics, Efficacy and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients - A Continuation of Clinical Study 069901". The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, and Part 2 is an evaluation of efficacy and safety. The study is open to patients who completed Baxt...

What is the current status of trial NCT00157053?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2001-11-22. Estimated completion is 2004-08-03.

What interventions are being tested in trial NCT00157053?

The interventions under investigation include: Antihemophilic factor, recombinant, manufactured protein-free (DRUG).

Who is sponsoring clinical trial NCT00157053?

This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00157053's enrollment target sits among peer trials

82 830th of 2000 higher than 1,167 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00157053, the US trial registry maintained by the National Library of Medicine. NCT00157053 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.