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NCT01992549 · ClinicalTrials.gov registry record · Phase 3

Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII

A Phase 3 study of Severe Hemophilia A, sponsored by Octapharma.

Completed
Registry status
Phase 3
Development phase
48
Enrollment target
15
Study locations

NCT01992549 is a Phase 3 study of Severe Hemophilia A that has completed, run by Octapharma. The registered enrollment target is 48 participants, below the 59-participant average among 4 other Severe Hemophilia A trials with a reported enrollment target (19% lower). The trial reports 15 study locations across 5 states.

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The verdict

NCT01992549, a Phase 3 study of Severe Hemophilia A, has completed, sponsored by Octapharma.

COMPLETED
Registry status
Phase 3
Development phase
48 participants
Enrollment target
15
Study locations

Study Summary

The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.

Conditions Studied

Interventions

  • BIOLOGICAL Human-cl rhFVIII

Study Locations (15)

Other

  • Hospital for Sick Children - Toronto
  • Hopital de la Timone - Marseille
  • Hôpital Kremlin Bicètre - Paris
  • Institute of Hematology and Transfusiology - Tbilisi
  • Sahyadri Speciality Hospital - Pune
  • Christian Medical College - Vellore
  • IMSP Mother and Child Institute - Chisinau
  • University Medical School - Warsaw
  • The National Children Specialized Hospital "OHMATDET" - Kiev
  • Danylo Halytsky Lviv National Medical University - Lviv
  • Great Ormond Street Hospital for Children - London

California

  • UC Davis Medical Center - Sacramento

Alberta

  • University of Alberta - Edmonton

British Columbia

  • BC Children's Hospital - Vancouver

Ontario

  • McMaster Children's Hospital - Hamilton

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2014-04
Est. Completion 2018-12-27
Phase Phase 3

Sponsor

Octapharma

43 total trials

What the Registry Record Tells You About NCT01992549

The ClinicalTrials.gov registry entry for NCT01992549 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 59-participant average among 4 other Severe Hemophilia A trials with a reported enrollment target (19% lower). The listed sponsor is Octapharma, which has 43 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Severe Hemophilia A appearing as the primary indexed condition, and to 1 intervention - of which Human-cl rhFVIII is the first listed.

NCT01992549 reports 15 study locations spanning 5 distinct geographic areas - top geographies include Other, California, Alberta.

Frequently Asked Questions

What is clinical trial NCT01992549 about?

NCT01992549 is a clinical study titled "Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII". The purpose of the study is to collect long-term data on the inhibitor development rate of Human-cl rhFVIII in previously untreated patients with severe Hemophilia A.

What is the current status of trial NCT01992549?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 48 participants. The study started on 2014-04. Estimated completion is 2018-12-27.

What conditions does trial NCT01992549 study?

This clinical trial studies the following conditions: Severe Hemophilia A.

What interventions are being tested in trial NCT01992549?

The interventions under investigation include: Human-cl rhFVIII (BIOLOGICAL).

Who is sponsoring clinical trial NCT01992549?

This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01992549 being conducted?

This trial has 15 study locations across California, Alberta, British Columbia, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.