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

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ClinicalTrials.gov Identifier: NCT01575756
Recruitment Status : Completed
First Posted : April 11, 2012
Results First Posted : November 30, 2016
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):

April 9, 2012
April 11, 2012
October 5, 2016
November 30, 2016
November 30, 2016
June 2013
January 2015   (Final data collection date for primary outcome measure)
  • Fibrinogen Activity Normalized Area Under the Curve Standardized [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]
    Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment. The normalized area under the curve was standardized to a dose of 70 mg/kg.
  • Comparison of Maximum Clot Firmness Between Octafibrin and Haemocomplettan P/RiaSTAP at 1 hr Post Infusion [ Time Frame: Baseline to 1 hour post-treatment ]
    Thromboelastography (TEG) using rotational thromboelastometry (ROTEM®) was used to measure maximum clot firmness. Rotational thromboelastometry is a method for the continuous measurement of clot formation. Maximum clot firmness is a functional parameter that depends on the activation of coagulation, the platelet and fibrinogen content of the blood sample, and the polymerisation and cross-linking of the fibrin network. In order to obtain comparable results from all study centres, maximum clot firmness data were assessed from frozen citrated plasma samples in a central laboratory. As these samples did not contain platelets that would be found in the whole blood assay, only the fibrinogen content defined the maximum clot firmness.
Pharmacokinetics [ Time Frame: 1 year ]
A comparison of the area under the curve (AUC) between Octafibrin and Haemocomplettan/Riastap
Complete list of historical versions of study NCT01575756 on ClinicalTrials.gov Archive Site
  • Fibrinogen Activity Normalized Area Under the Curve Unstandardized [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]
    fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
  • Incremental in Vivo Recovery [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]
    Incremental in vivo recovery was calculated as the maximum increase in plasma fibrinogen (fibrinogen activity assay data) within 4 hours post-treatment as compared with pre-treatment (expressed as an absolute mg/dL concentration in plasma), divided by the exact dose of Octafibrin or Haemocomplettan® P or RiaSTAPTM (expressed as mg/kg dosed).
  • Terminal Half-life (t½) [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]
    Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
  • Clearance [ Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment ]
    Fibrinogen activity was determined via a validated Clauss assay (fibrinogen activity) and fibrinogen-specific enzyme-linked immunosorbent assay (ie, fibrinogen antigen) using paired antibodies for fibrinogen antigen. All determinations were performed on frozen plasma samples in a central laboratory. The Clauss assay was modified and validated to achieve a limit of quantification of 0.2 g/L. The pharmacokinetic analysis was assessed individually using a non-compartmental model. Plasma levels were measured at Baseline, 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment.
Efficacy [ Time Frame: 1 year ]
Comparison of MCF between Octafibrin and Haemocomplettan/Riastap at 1 hour post infusion
Not Provided
Not Provided
 
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
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Congenital Fibrinogen Deficiency
  • Afibrinogenemia
  • Biological: Octafibrin
    Octafibrin was supplied as a powder for reconstitution with water for injection.
    Other Name: Plasma derived fibrinogen concentrate
  • Biological: Haemocomplettan® P or RiaSTAPTM
    Commercially available Haemocomplettan® P or RiaSTAPTM (same product with different names in different markets) were supplied as powders for reconstitution with water for injection.
    Other Name: Plasma derived fibrinogen concentrate
  • Experimental: Octafibrin followed by Haemocomplettan® P or RiaSTAPTM
    Participants received Octafibrin 70 mg/kg intravenously once followed by Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once 45 days later.
    Interventions:
    • Biological: Octafibrin
    • Biological: Haemocomplettan® P or RiaSTAPTM
  • Experimental: Haemocomplettan® P or RiaSTAPTM followed by Octafibrin
    Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once followed by Octafibrin 70 mg/kg intravenously once 45 days later.
    Interventions:
    • Biological: Octafibrin
    • Biological: Haemocomplettan® P or RiaSTAPTM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
22
January 2015
January 2015   (Final data collection date for primary outcome measure)

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.
  • Human immunodeficiency virus (HIV) positive with a viral load > 200 particles/µl or > 400000 copies/mL.
  • End-stage liver disease.
  • History of oesophageal varicose bleeding.
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   India,   Iran, Islamic Republic of,   Switzerland,   United Kingdom,   United States
Germany,   Italy
 
NCT01575756
FORMA-01
No
Not Provided
Not Provided
Octapharma
Octapharma
Not Provided
Study Director: Sigurd Knaub, PhD Octapharma
Octapharma
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP