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NCT00157157 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety Study of a Recombinant Protein-Free Manufactured Factor VIII (rAHF-PFM) in Previously Untreated Hemophilia A Patients

A Phase 3 study, sponsored by Baxalta now part of Shire.

Completed
Registry status
Phase 3
Development phase
66
Enrollment target

NCT00157157 is a Phase 3 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 66 participants.

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The verdict

NCT00157157, a Phase 3 study, has completed, sponsored by Baxalta now part of Shire.

COMPLETED
Registry status
Phase 3
Development phase
66 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate whether Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) is effective and safe in the treatment of hemophilia A patients who have not been treated with factor VIII (FVIII) before.

Interventions

  • BIOLOGICAL Recombinant Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM)

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2004-04-01
Est. Completion 2009-09-11
Phase Phase 3

Sponsor

Baxalta now part of Shire

74 total trials

What the Registry Record Tells You About NCT00157157

The ClinicalTrials.gov registry entry for NCT00157157 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Recombinant Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM) is the first listed.

NCT00157157 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00157157 about?

NCT00157157 is a clinical study titled "Efficacy and Safety Study of a Recombinant Protein-Free Manufactured Factor VIII (rAHF-PFM) in Previously Untreated Hemophilia A Patients". The purpose of this study is to evaluate whether Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) is effective and safe in the treatment of hemophilia A patients who have not been treated with factor VIII (FVIII) before.

What is the current status of trial NCT00157157?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 66 participants. The study started on 2004-04-01. Estimated completion is 2009-09-11.

What interventions are being tested in trial NCT00157157?

The interventions under investigation include: Recombinant Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM) (BIOLOGICAL).

Who is sponsoring clinical trial NCT00157157?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.