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NCT01486927 · ClinicalTrials.gov registry record · Phase 2

An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A

A Phase 2 study of Hemophilia A, sponsored by CSL Behring.

Completed
Registry status
Phase 2
Development phase
175
Enrollment target
20
Study locations

NCT01486927 is a Phase 2 study of Hemophilia A that has completed, run by CSL Behring. The registered enrollment target is 175 participants, above the 87-participant average among 42 other Hemophilia A trials with a reported enrollment target (101% higher). The trial reports 20 study locations across 9 states.

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The verdict

NCT01486927, a Phase 2 study of Hemophilia A, has completed, sponsored by CSL Behring.

COMPLETED
Registry status
Phase 2
Development phase
175 participants
Enrollment target
20
Study locations

Study Summary

This is an open-label, non-randomized, efficacy, safety and pharmacokinetic (PK) study comparing octocog alfa and rVIII-SingleChain. The study consists of three parts, a PK period (Part 1), a continuation of dosing safety and efficacy period (Part 2) and a safety, efficacy, and repeat PK period (Part 3) and also includes a surgical sub-study for subjects enrolled in Parts 2 and 3.

Conditions Studied

Hemophilia A

Interventions

  • BIOLOGICAL rVIII-SingleChain
  • BIOLOGICAL Octocog alfa

Study Locations (20)

Other

  • Study Site - Nedlands
  • Study Site - Perth
  • Study Site - Graz
  • Study Site - Vienna
  • Study Site - New Brunswick
  • Study Site - Hradec Králové
  • Study Site - Berlin
  • Study Site - Berlin
  • Study Site - Bonn
  • Study Site - Giessen
  • Study Site - Hamburg

California

  • Study Site - Sacramento
  • Study Site - San Diego

Colorado

  • Study Site - Aurora

Connecticut

  • Study Site - Hartford

Florida

  • Study Site - Miami

Illinois

  • Study Site - Chicago

Louisiana

  • Study Site - New Orleans

Texas

  • Study Site - Houston

Trial Details

FieldValue
Enrollment Target 175 participants
Start Date 2012-02
Est. Completion 2014-12
Phase Phase 2

Sponsor

CSL Behring

71 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01486927

The ClinicalTrials.gov registry entry for NCT01486927 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 87-participant average among 42 other Hemophilia A trials with a reported enrollment target (101% higher). The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hemophilia A appearing as the primary indexed condition, and to 2 interventions - of which rVIII-SingleChain is the first listed.

NCT01486927 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, California, Colorado.

Frequently Asked Questions

What is clinical trial NCT01486927 about?

NCT01486927 is a clinical study titled "An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A". This is an open-label, non-randomized, efficacy, safety and pharmacokinetic (PK) study comparing octocog alfa and rVIII-SingleChain. The study consists of three parts, a PK period (Part 1), a continuation of dosing safety and efficacy period (Part 2) and a safety, efficacy, and repeat PK period (Par...

What is the current status of trial NCT01486927?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 175 participants. The study started on 2012-02. Estimated completion is 2014-12.

What conditions does trial NCT01486927 study?

This clinical trial studies the following conditions: Hemophilia A.

What interventions are being tested in trial NCT01486927?

The interventions under investigation include: rVIII-SingleChain (BIOLOGICAL), Octocog alfa (BIOLOGICAL).

Who is sponsoring clinical trial NCT01486927?

This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01486927 being conducted?

This trial has 20 study locations across California, Colorado, Connecticut, Florida, Illinois. 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.