Phase 2
N=22
Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
Congenital Fibrinogen Deficiency · Afibrinogenemia
Bottom Line
View on ClinicalTrials.gov: NCT01575756 ↗Enrolled (actual)
22
Serious AEs
2.3%
Results posted
Nov 2016
Primary outcome: Primary: Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized — 1.196 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Octafibrin (Biological); Haemocomplettan® P or RiaSTAPTM (Biological)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Octapharma
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized |
1.196 | — |
| PRIMARY Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post Infusion |
9.68; 10.00 | — |
| SECONDARY Fibrinogen Activity Normalized Area Under the Curve Unstandardized |
1.62; 1.38 | — |
| SECONDARY Fibrinogen Activity Normalized Area Under the Curve Standardized |
113.70; 96.39 | — |
| SECONDARY Maximum Plasma Concentration Normalized (Cmaxnorm) |
0.018; 0.018 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) Unstandardized |
1.390; 1.265 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) Standardized |
1.266; 1.271 | — |
| SECONDARY Incremental in Vivo Recovery |
1.787; 1.770 | — |
| SECONDARY Classical in Vivo Recovery |
64.397; 66.046 | — |
| SECONDARY Time to Reach Maximum Plasma Concentration (Tmax) |
2.148; 1.417 | — |
| SECONDARY Terminal Half-life (t½) |
75.940; 69.378 | — |
| SECONDARY Mean Residence Time (MRT) |
106.272; 98.977 | — |
| SECONDARY Clearance |
0.665; 0.804 | — |
| SECONDARY Volume of Distribution at Steady State (Vss) |
70.158; 76.631 | — |
Summary
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
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01575756). 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.