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COMPLETED 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

NCT01486927 · View on ClinicalTrials.gov ↗

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

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

85 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 85 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01486927 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Other, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01486927?

The interventions under investigation include: rVIII-SingleChain (BIOLOGICAL), Octocog alfa (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01486927?

This trial is sponsored by CSL Behring, which has 85 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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