Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery

Brief Title

Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery

Official Title

Prospective, Open-label, Uncontrolled, Phase III Study to Assess the Efficacy and Safety of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery in Subjects With Congenital Fibrinogen Deficiency

Brief Summary

      The purpose of the study is to assess the efficacy and safety of Octafibrin for on-demand
      treatment of acute bleeding in subjects with congenital fibrinogen deficiency.
    


Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in Treating the First Documented Bleeding Episode of Each Patient.

Secondary Outcome

 Maximum Clot Firmness (MCF) After Fibrinogen Infusion in Each Documented Bleeding Episode (BE), Measured in Frozen Plasma in a Central Laboratory.

Condition

Congenital Fibrinogen Deficiency

Intervention

Octafibrin

Study Arms / Comparison Groups

 Octafibrin
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

25

Start Date

September 2014

Completion Date

February 14, 2018

Primary Completion Date

February 14, 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Aged ≥12 years (only 18 and above in Russia)

          -  Documented diagnosis of congenital fibrinogen deficiency, expected to require
             on-demand treatment for bleeding or surgical prophylaxis:

          -  Fibrinogen deficiency manifested as afibrinogenaemia or severe hypofibrinogenaemia.

          -  Historical plasma fibrinogen activity of <50 mg/dL or levels below the limit of
             detection of the local assay method.

          -  Expected to have an acute bleeding episode (spontaneous or after trauma) or planning
             to undergo elective surgery.

          -  Informed consent signed by the subject or legal guardian.

        Exclusion Criteria:

          -  Life expectancy <6 months.

          -  Bleeding disorder other than congenital fibrinogen deficiency, including
             dysfibrinogenaemia.

          -  Prophylactic treatment with a fibrinogen concentrate.

        Treatment with:

          -  Any fibrinogen concentrate or other fibrinogen-containing blood product within 2 weeks
             prior to start of treatment for the bleeding episode or surgery.

          -  Any coagulation-active drug (i.e., non-steroidal anti-inflammatory drugs, warfarin,
             coumarin derivatives, platelet aggregation inhibitors) within 1 week prior to start of
             treatment for the bleeding episode or surgery, or as a planned or expected medication
             during the time period from Day 1 until 24 hours (i.e., 1 day) after the last
             Octafibrin infusion.

        Presence or history of:

          -  Hypersensitivity to study medication.

          -  Deep vein thrombosis or pulmonary embolism within 1 year prior to start of treatment
             for the bleeding episode or surgery.

          -  Arterial thrombosis within 1 year prior to start of treatment for the bleeding episode
             or surgery

          -  Hypersensitivity to human plasma proteins.

          -  Oesophageal varicose bleeding.

          -  End-stage liver disease (i.e., Child-Pugh score B or C).

        Pregnant women within the first 20 weeks of gestation.

        Currently breast-feeding.

        Known positive HIV infection with a viral load >200 particles/μL or >400,000 copies/mL.

        Polytrauma 1 year prior to start of treatment for the bleeding episode or surgery.

        Diagnosis or suspicion of a neutralizing anti-fibrinogen inhibitor currently or any time in
        the past.

        Acute or chronic medical condition which may, in the opinion of investigator, affect the
        conduct of the study, including

          -  Subjects receiving immune-modulating drugs (other than anti-retroviral chemotherapy)
             such as alpha-interferon, prednisone (equivalent to >10 mg/day), or similar drugs at
             study start.

          -  Subjects having evidence or a history (within the previous 12 months) of abuse of any
             licit or illicit drug substance.

        Participation in another interventional clinical study currently or during the past 4
        weeks.
      

Gender

All

Ages

12 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Cristina Solomon, MD, , 

Location Countries

Bulgaria

Location Countries

Bulgaria

Administrative Informations


NCT ID

NCT02267226

Organization ID

FORMA-02


Responsible Party

Sponsor

Study Sponsor

Octapharma


Study Sponsor

Cristina Solomon, MD, Study Director, Octapharma


Verification Date

December 2020