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NCT00989196 · ClinicalTrials.gov registry record · Phase 2
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A
A Phase 2 study, sponsored by Octapharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT00989196: Completed Phase 2 study, sponsored by Octapharma.
NCT00989196 is a Phase 2 study that has completed, run by Octapharma. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00989196, a Phase 2 study, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.
Primary Outcome
After the infusion of 50IU/kg bw of Human-cl rhFVIII and Kogenate FS respectively, FVIII activity levels were measured at various time points before and after the infusion. FVIII level results derived from the chromogenic FVIII assay were used to calculate the mean of the area under the curve normalized to the dose administered.
Interventions
- BIOLOGICAL Human-cl rhFVIII
- BIOLOGICAL Kogenate FS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
What the finished NCT00989196 record still lists
NCT00989196 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Human-cl rhFVIII is the first listed.
NCT00989196 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00989196 about?
NCT00989196 is a clinical study titled "Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A". This is a clinical study to investigate the pharmacokinetics, efficacy, safety and immunogenicity of human-cl rhFVIII, a newly developed human cell-line derived recombinant FVIII concentrate in previously treated patients with severe Hemophilia A.
What is the current status of trial NCT00989196?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2010-05. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00989196?
The interventions under investigation include: Human-cl rhFVIII (BIOLOGICAL), Kogenate FS (BIOLOGICAL).
Who is sponsoring clinical trial NCT00989196?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00989196's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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