Loading clinical trials...

Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

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

NCT01575756•Octapharma

View on ClinicalTrials.gov

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

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age ≥ 12 years.
•Documented congenital fibrinogen deficiency (afibrinogenemia).

Exclusion Criteria

•Life expectancy \> 6 month.
•Bleeding disorder other than congenital fibrinogen deficiency.
•Presence or history of hypersensitivity to study medication.
•Presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment.
•Presence or history of arterial thrombosis with 1 year prior to enrollment.
•Hypersensitivity to human plasma products.
•Acute bleeding.
•Pregnant or currently breast-feeding women.
•Suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery (if available).
•Blood or plasma donation in the 3 months prior to enrollment.
+3 more criteria

Locations (10)

University of Colorado Hemophilia & Thrombosis Center

Aurora, Colorado, United States

Cohen Children's Medical Center of New York

New Hyde Park, New York, United States

Specialized Hospital for Active Treatment "Joan Pavel"

Sofia, Bulgaria

Department of Hematology St. John's Medical College Hospital

Bangalore, India

Sahyadri Speciality Hospital

Prune, India

Department of Hematology Christian Medical College

Vellore, India

Nemazee Hospital Shiraz University of Medical Sciences

Shiraz, Iran

Tehran University of Medical Sciences

Tehran, Iran

Department of Hematology University Hospital

Zurich, Switzerland

The Centre for Haemostatis and Thrombosis

London, United Kingdom

Key Dates

Start Date

June 1, 2013

Primary Completion Date

January 1, 2015

Completion Date

January 1, 2015

Last Updated

March 9, 2018

Enrollment

ACTUAL participants

Conditions

Congenital Fibrinogen DeficiencyAfibrinogenemia

Interventions

Octafibrin

BIOLOGICAL

Haemocomplettan® P or RiaSTAPTM

BIOLOGICAL

Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency

NCT03793426

Congenital Fibrinogen Deficiency

View study

WITHDRAWNPHASE3

Fibrinogen Concentrate (Human) - Efficacy and Safety Study

NCT00916656

AfibrinogenemiaHypofibrinogenemia+1 more

View study

COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

Inclusion Criteria

Exclusion Criteria

Safety and Efficacy of Fibryga in Congenital Fibrinogen Deficiency

Fibrinogen Concentrate (Human) - Efficacy and Safety Study

Human Fibrinogen Concentrate in Pediatric Cardiac Surgery