Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01575756 · ClinicalTrials.gov registry record · Phase 2
Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
A Phase 2 study, sponsored by Octapharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT01575756: Completed Phase 2 study, sponsored by Octapharma.
NCT01575756 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
NCT01575756, a Phase 2 study, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital fibrinogen deficiency
Primary Outcome
Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were
Interventions
- BIOLOGICAL Octafibrin
- BIOLOGICAL Haemocomplettan® P or RiaSTAPTM
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
What the finished NCT01575756 record still lists
NCT01575756 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 Octafibrin is the first listed.
NCT01575756 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01575756 about?
NCT01575756 is a clinical study titled "Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap". The purpose of this study is to investigate pharmacokinetic properties, surrogate efficacy and safety of Octafibrin compared to Haemocomplettan® P/RiaSTAPTM in patients with congenital fibrinogen deficiency
What is the current status of trial NCT01575756?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2013-06. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01575756?
The interventions under investigation include: Octafibrin (BIOLOGICAL), Haemocomplettan® P or RiaSTAPTM (BIOLOGICAL).
Who is sponsoring clinical trial NCT01575756?
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 NCT01575756'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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02508038 · 22 participants · Phase 1
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
- NCT03099356 · 22 participants · Phase 2
Cyclophosphamide and Sirolimus for the Treatment of Metastatic, RAI-refractory, Differentiated Thyroid Cancer
- NCT03676647 · 22 participants
Diagnostic DNA Methylation Signature in Diagnosing Thyroid Cancer After Fine-Needle Aspiration in Patients With Thyroid Nodules
- NCT04569591 · 22 participants · NA
DDAVP for Pituitary Adenoma
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia