Status:
COMPLETED
Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery
Lead Sponsor:
Octapharma
Conditions:
Congenital Fibrinogen Deficiency
Eligibility:
All Genders
12+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2018
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02267226
Start Date
September 1 2014
End Date
February 14 2018
Last Update
January 15 2021
Active Locations (12)
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1
Miami Children's Hospital
Miami, Florida, United States, 33155
2
Dept of Clinical Hematology for Hemorrhagic Diatheses and Anaemia, SHAT "Joan Pavel"
Sofia, Bulgaria
3
St. John's Medical College Hospital
Bangalore, India
4
Sahyadri Specialty Hospital
Pune, India