Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery
Completed · Phase 3
Conditions studied: Congenital Fibrinogen Deficiency
In brief
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.
Key facts
- Study ID
- NCT02267226
- Run by
- Octapharma
- People needed
- 25
- Starts
- 2014-09-01
- Expected to finish
- 2018-02-14
- Last updated by the study team
- 2021-01-15
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Miami Children's Hospital — Miami, Florida, United States
- Dept of Clinical Hematology for Hemorrhagic Diatheses and Anaemia, SHAT "Joan Pavel" — Sofia, Bulgaria
- St. John's Medical College Hospital — Bangalore, India
- Sahyadri Specialty Hospital — Pune, India
- Dept of Hematology, Christian Medical College — Vellore, India
- Seyed Al Shohada Hospital — Isfahan, Iran
- Dastgheib Hospital — Shīrāz, Iran
- Hotel-Dieu de France — Beirut, Lebanon
- Haematological Scientific Center of Ministry of Healthcare of the Russian Federation — Moscow, Russia
- Centre of Excellence in Thrombosis & Hemostasis, King Saud University — Riyadh, Saudi Arabia
- Dept of Haematology, Ege University Children's Hospital — Izmir, Turkey (Türkiye)
- Centre for Haemostasis & Thrombosis, St Thomas' Hospital — London, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.