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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

The annualized number of bleeds experienced by participants

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
Bayer

591 total trials

What the finished NCT01233258 record still lists

NCT01233258 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 90-participant average among 42 other Hemophilia A trials with a reported enrollment target (11% lower).

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 names 20 study sites across 14 states, led by 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.

Learn More About Clinical Trials

Similar trials for Hemophilia A

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01233258's enrollment target sits among peer trials

80 17th of 42 higher than 26 of 42 other Hemophilia A trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hemophilia A 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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Related registry views

Source: ClinicalTrials.gov NCT01233258, the US trial registry maintained by the National Library of Medicine. NCT01233258 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.