Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01575756
• Date of registration: 09/04/2012
• Prospective Registration: Yes
• Primary sponsor: Octapharma
• Public title: Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap
• Scientific title: A Prospective, Controlled, Randomised, Crossover Study Investigating the Pharmacokinetic Properties, Surrogate Efficacy and Safety of Octafibrin Compared to Haemocomplettan® P/RiaSTAPTM in Patients With Congenital Fibrinogen Deficiency
• Date of first enrolment: June 2013
• Target sample size: 22
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01575756
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Bulgaria, Germany, India, Iran, Islamic Republic of, Italy, Switzerland, United Kingdom, United States

Contacts

• Name: Sigurd Knaub, PhD
• Affiliation: Octapharma

Key inclusion & exclusion 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.



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Afibrinogenemia

Congenital Fibrinogen Deficiency

Intervention(s)

Biological: Haemocomplettan® P or RiaSTAPTM

Biological: Octafibrin

Primary Outcome(s)

Comparison of Maximum Clot Firmness Between Octafibrin/FIBRYGA® and Haemocomplettan® P/RiaSTAP(TM) at 1 hr Post Infusion [Time Frame: 1 hour post-treatment]

Ratio of Octafibrin/FIBRYGA® to Haemocomplettan® P/RiaSTAP(TM) for Fibrinogen Activity Normalized Area Under the Curve Unstandardized [Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment]

Secondary Outcome(s)

Maximum Plasma Concentration (Cmax) Standardized [Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment]

Fibrinogen Activity Normalized Area Under the Curve Standardized [Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment]

Fibrinogen Activity Normalized Area Under the Curve Unstandardized [Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment]

Mean Residence Time (MRT) [Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment]

Volume of Distribution at Steady State (Vss) [Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment]

Clearance [Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment]

Incremental in Vivo Recovery [Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment]

Classical in Vivo Recovery [Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment]

Maximum Plasma Concentration Normalized (Cmaxnorm) [Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment]

Maximum Plasma Concentration (Cmax) Unstandardized [Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment]

Time to Reach Maximum Plasma Concentration (Tmax) [Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment]

Terminal Half-life (t½) [Time Frame: Baseline to 0.5, 1, 2, 4, 8, 24, 48, 96, 144, 216, and 312 hours post-treatment]

Secondary ID(s)

FORMA-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/11/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01575756