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NCT02093897 · ClinicalTrials.gov registry record · Phase 3
Pharmacokinetic, Efficacy, and Safety Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) in Children With Severe Hemophilia A
A Phase 3 study, sponsored by CSL Behring.
- Completed
- Registry status
- Phase 3
- Development phase
- 84
- Enrollment target
NCT02093897 is a Phase 3 study that has completed, run by CSL Behring. The registered enrollment target is 84 participants.
The verdict
NCT02093897, a Phase 3 study, has completed, sponsored by CSL Behring.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 84 participants
- Enrollment target
Study Summary
This is an international, multicenter, open-label study to assess the efficacy, safety, and pharmacokinetic (PK) profile of rVIII-SingleChain in pediatric patients with severe hemophilia A. A minimum of 25 previously treated subjects ≥ 6 to \< 12 years of age and at least 25 subjects \< 6 years of age who have undergone \> 50 exposure days (EDs) with a previous Factor VIII (FVIII) product are planned to be enrolled. Subjects will be assigned to either an on-demand or prophylaxis treatment regimen and will receive rVIII-SingleChain at a dose to be determined by the investigator. Hemostatic efficacy will be assessed by the subject/caregiver and the investigator who will assess overall efficacy by a 4-point scale.
Interventions
- BIOLOGICAL rVIII-SingleChain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2014-03 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02093897
The ClinicalTrials.gov registry entry for NCT02093897 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which rVIII-SingleChain is the first listed.
NCT02093897 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02093897 about?
NCT02093897 is a clinical study titled "Pharmacokinetic, Efficacy, and Safety Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) in Children With Severe Hemophilia A". This is an international, multicenter, open-label study to assess the efficacy, safety, and pharmacokinetic (PK) profile of rVIII-SingleChain in pediatric patients with severe hemophilia A. A minimum of 25 previously treated subjects ≥ 6 to \< 12 years of age and at least 25 subjects \< 6 years of a...
What is the current status of trial NCT02093897?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 84 participants. The study started on 2014-03. Estimated completion is 2015-08.
What interventions are being tested in trial NCT02093897?
The interventions under investigation include: rVIII-SingleChain (BIOLOGICAL).
Who is sponsoring clinical trial NCT02093897?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
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