Phase 3
N=25
Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery
Congenital Fibrinogen Deficiency
Bottom Line
View on ClinicalTrials.gov: NCT02267226 ↗Enrolled (actual)
25
Serious AEs
20.0%
Results posted
Feb 2019
Primary outcome: Primary: Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in Treating the First Documented Bleeding Episode of Each Patient. — 19; 23; 5; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Octafibrin (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Octapharma
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Clinical Assessment of the Haemostatic Efficacy of Octafibrin in Treating the First Documented Bleeding Episode of Each Patient. |
19; 23; 5; 1; 0; 0 | — |
| SECONDARY Maximum Clot Firmness (MCF) After Fibrinogen Infusion in Each Documented Bleeding Episode (BE), Measured in Frozen Plasma in a Central Laboratory. |
5.79 | — |
| SECONDARY Fibrinogen Plasma Level |
0.13; 109.01; 104.46; 70.77 | — |
| SECONDARY Response as Indicated by Incremental in Vivo Recovery (IVR) |
1.82 | — |
| SECONDARY Efficacy of Octafibrin for All Bleeding Episodes Collected in the Study |
70; 81; 16; 7; 1; 1 | — |
| SECONDARY Efficacy of Octafibrin in Preventing Bleeding During and After Surgery |
11; 11; 12; 11; 1; 1 | — |
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 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 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.
Data sourced from ClinicalTrials.gov (NCT02267226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.