CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Octafibrin +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01575756
NCT01575756Phase 2Completed
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A Prospective, Controlled, Randomised, Crossover Study Investigating the Pharmacokinetic Properties, Surrogate Efficacy and Safety of Octafibrin Compared to Haemocomplettan® P/RiaSTAPTM in Patients With Congenital Fibrinogen Deficiency

Octapharma·interventional·Posted Apr 11, 2012·Updated Mar 9, 2018

In Brief

A Phase 2 clinical trial evaluating Octafibrin and Haemocomplettan® P or RiaSTAPTM for Congenital Fibrinogen Deficiency and Afibrinogenemia. Completed, enrolled 22 participants across 10 sites in 6 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCongenital Fibrinogen Deficiency, Afibrinogenemia
CountriesBulgaria, India, Iran, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 11, 2012
Enrollment StartJun 1, 2013
Primary CompletionJan 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.2 years ago

Interventions

Octafibrinbiological

Octafibrin was supplied as a powder for reconstitution with water for injection.

Haemocomplettan® P or RiaSTAPTMbiological

Commercially available Haemocomplettan® P or RiaSTAPTM (same product with different names in different markets) were supplied as powders for reconstitution with water for injection.