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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Octapharma
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01575756
First received: April 9, 2012
Last updated: June 20, 2014
Last verified: June 2014
  Purpose

The purpose of the study is to determine pharmacokinetics and the maximum clot strength (MCF) as an indicator for haemostatic efficacy of Octafibrin and Haemocomplettan/Riastap in subjects with congenital fibrinogen deficiency.


Condition Intervention Phase
Congenital Fibrinogen Deficiency
Afibrinogenemia
Biological: Octafibrin - (Factor I concentrate)
Biological: Haemocomplettan/Riastap (Factor I concentrate)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Controlled, Randomised, Cross-over Study Investigating the Pharmacokinetic Properties, Surrogate Efficacy and Safety of Octafibrin Compared to Haemocomplettan.Riastap in Subjects With Congenital Fibrinogen Deficiency

Resource links provided by NLM:


Further study details as provided by Octapharma:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    A comparison of the area under the curve (AUC) between Octafibrin and Haemocomplettan/Riastap


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Comparison of MCF between Octafibrin and Haemocomplettan/Riastap at 1 hour post infusion


Estimated Enrollment: 18
Study Start Date: May 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Octafibrin Biological: Octafibrin - (Factor I concentrate)
Single intravenous infusion of 70 mg/kg body weight
Active Comparator: Haemocomplettan/Riastap Biological: Haemocomplettan/Riastap (Factor I concentrate)
Single intravenous infusion of 70 mg/kg bodyweight

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age =>12 year
  • 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 month prior to enrollment
  • HIV positive with a viral load > 200 particles/ul or > 400000 copies/mL
  • End-stage liver disease
  • History of oesophageal varicose bleeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01575756

Contacts
Contact: Bruce Schwartz, PhD 2016041112

Locations
United States, Colorado
University of Colorado Hemophilia & Thrombosis Center Recruiting
Aurora, Colorado, United States, 80045
United States, New York
Cohen Children's Medical Center of New York Recruiting
New Hyde Park, New York, United States, 11040
Bulgaria
Specialized Hospital for Active Treatment "Joan Pavel" Recruiting
Sofia, Bulgaria
Germany
Hospital of Johann Wolfgang Goethe University Recruiting
Frankfurt, Germany
India
Department of Hematology St. John's Medical College Hospital Recruiting
Bangalore, India
Sahyadri Speciality Hospital Recruiting
Prune, India
Department of Hematology Christian Medical College Recruiting
Vellore, India
Iran, Islamic Republic of
Nemazee Hospital Shiraz University of Medical Sciences Recruiting
Shiraz, Iran, Islamic Republic of
Tehran University of Medical Sciences Recruiting
Tehran, Iran, Islamic Republic of
Italy
University of Milan Department of Internal Medicine Recruiting
Milan, Italy
Hospital "SS Annunziata" ASL 1 Recruiting
Sassari, Italy
Switzerland
Department of Hematology University Hospital Recruiting
Zurich, Switzerland
United Kingdom
The Centre for Haemostatis and Thrombosis Recruiting
London, United Kingdom
Sponsors and Collaborators
Octapharma
Investigators
Study Director: Sigurd Knaub, PhD Octapharma
  More Information

No publications provided

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01575756     History of Changes
Other Study ID Numbers: FORMA-01
Study First Received: April 9, 2012
Last Updated: June 20, 2014
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Paul-Ehrlich-Institut
Bulgaria: Bulgarian Drug Agency
Switzerland: Swissmedic
India: Drugs Controller General of India
Italy: Instituto Superiore di Sanita
Iran: Ministry of Health/Food & Drug Department (MOH), Drug and Narcotics surveillance department

Additional relevant MeSH terms:
Afibrinogenemia
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Complement Factor I
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 16, 2014