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NCT01233258 · ClinicalTrials.gov registry record · Phase 3

A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A

A Phase 3 study of Hemophilia A, sponsored by Bayer.

Completed
Registry status
Phase 3
Development phase
80
Enrollment target
20
Study locations

NCT01233258 is a Phase 3 study of Hemophilia A that has completed, run by Bayer. The registered enrollment target is 80 participants, below the 90-participant average among 42 other Hemophilia A trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 14 states.

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The verdict

NCT01233258, a Phase 3 study of Hemophilia A, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 3
Development phase
80 participants
Enrollment target
20
Study locations

Study Summary

The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.

Conditions Studied

Hemophilia A

Interventions

  • BIOLOGICAL rFVIII (BAY81-8973) on demand
  • BIOLOGICAL rFVIII (BAY81-8973) prophylaxis low-dose
  • BIOLOGICAL rFVIII (BAY81-8973) prophylaxis high-dose

Study Locations (20)

Other

  • - Beijing
  • - Shanghai
  • - Tianjin
  • - Olomouc
  • - Hyderabad
  • - Jakarta

Tokyo

  • - Shinjuku-ku
  • - Suginami

Ohio

  • - Dayton

Texas

  • - Houston

Ciudad Auton. de Buenos Aires

  • - Buenos Aires

Corrientes Province

  • - Corrientes

Santa Fe Province

  • - Rosario

Guangdong

  • - Guangzhou

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2011-01
Est. Completion 2012-12
Phase Phase 3

Sponsor

Bayer

591 total trials

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What the Registry Record Tells You About NCT01233258

The ClinicalTrials.gov registry entry for NCT01233258 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90-participant average among 42 other Hemophilia A trials with a reported enrollment target (11% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 3 interventions - of which rFVIII (BAY81-8973) on demand is the first listed.

NCT01233258 reports 20 study locations spanning 14 distinct geographic areas - top geographies include Other, Tokyo, Ohio.

Frequently Asked Questions

What is clinical trial NCT01233258 about?

NCT01233258 is a clinical study titled "A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A". The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.

What is the current status of trial NCT01233258?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2011-01. Estimated completion is 2012-12.

What conditions does trial NCT01233258 study?

This clinical trial studies the following conditions: Hemophilia A.

What interventions are being tested in trial NCT01233258?

The interventions under investigation include: rFVIII (BAY81-8973) on demand (BIOLOGICAL), rFVIII (BAY81-8973) prophylaxis low-dose (BIOLOGICAL), rFVIII (BAY81-8973) prophylaxis high-dose (BIOLOGICAL).

Who is sponsoring clinical trial NCT01233258?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01233258 being conducted?

This trial has 20 study locations across Ohio, Texas, Ciudad Auton. de Buenos Aires, Corrientes Province, Santa Fe Province. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.