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Trial record 2 of 4 for:    "Afibrinogenemia"
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Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

This study is not yet open for participant recruitment.
Verified February 2013 by Octapharma
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01575756
First received: April 9, 2012
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  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:

Drug Information available for: Fibrinogen
U.S. FDA Resources

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: March 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575756

Contacts
Contact: Bruce Schwartz, PhD 2016041112

Locations
Italy
A. Bianchi Bonomi Hemophilia and Thrombosis Center Not yet recruiting
Milan, Italy, 20122
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: February 22, 2013
Health Authority: United States: Food and Drug Administration

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 May 23, 2013