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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01575756
First received: April 9, 2012
Last updated: October 14, 2015
Last verified: October 2015
  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


Enrollment: 22
Study Start Date: May 2013
Study Completion Date: September 2015
Primary Completion Date: January 2015 (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   (Child, Adult, Senior)
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

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

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01575756     History of Changes
Other Study ID Numbers: FORMA-01 
Study First Received: April 9, 2012
Last Updated: October 14, 2015
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

ClinicalTrials.gov processed this record on August 22, 2016