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Study to Investigate Immunogenicity, Efficacy and Safety of Treatment With Human-cl rhFVIII
NCT01992549 · View on ClinicalTrials.gov ↗
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
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-04 |
| Est. Completion | 2018-12-27 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01992549
The ClinicalTrials.gov registry entry for NCT01992549 describes a study currently listed as completed. It is categorized as Phase 3, 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 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Octapharma, which has 73 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 Severe Hemophilia A appearing as the primary indexed condition, and to 1 intervention — of which Human-cl rhFVIII 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: NCT01992549 reports 15 study locations spanning 5 distinct geographic areas — top geographies include Other, California, Alberta. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01992549?
The interventions under investigation include: Human-cl rhFVIII (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01992549?
This trial is sponsored by Octapharma, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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