A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01063595
• Date of registration: 04/02/2010
• Prospective Registration: No
• Primary sponsor: Octapharma
• Public title: A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD
• Scientific title: A Comparative, Open-label, Randomized, Cross-over Phase I Trial in Healthy Volunteers to Investigate the Relative Efficacy, Safety and Tolerability of Octaplas LG™ vs. Octaplas®
• Date of first enrolment: December 2009
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01063595
• Study type: Interventional
• Phase: Phase 1

Countries of recruitment

Austria

Key inclusion & exclusion criteria

Inclusion Criteria:

- Capable of understanding and complying with all aspects of the protocol.

- Signed Informed Consent.

- Capable of understanding the plasmapheresis information sheet and sign it.

- Healthy male or female volunteers, age 18 years or older.

- Women must have negative pregnancy test (human chorionic gonadotropin [HCG] based
assay).

- Women must have sufficient methods of contraception (eg, intrauterine device, oral
contraception, etc).

- No clinically relevant abnormalities in medical history and general physical
examination.

- Standard health insurance.

Exclusion Criteria:

- Pregnancy or lactation.

- Tattoos within the last 3 months.

- Subject was treated therapeutically with fresh frozen plasma, blood, or plasma-derived
products within the last 6 months.

- Hypersensitivity to blood products or plasma proteins.

- History of angioedema.

- History of coagulation or bleeding disorder or any other known abnormality affecting
coagulation, fibrinolysis, or platelet function.

- Any clinically significant abnormal laboratory values.

- IgA deficiency.

- Seropositivity for hepatitis B surface antigen, hepatitis C virus, or human
immunodeficiency virus type 1 or type 2 antibodies.

- Symptoms of a clinically relevant illness within 3 weeks before the first trial day.

- History of or suspected drug or alcohol abuse.

- Subjects currently participating in another clinical study.

- Any investigational medicinal product administration within the last 4 weeks.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Comparison of Octaplas LG and Octaplas SD

Intervention(s)

Biological: Octaplas LG

Biological: Octaplas SD

Primary Outcome(s)

Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C [Time Frame: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration]

Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI [Time Frame: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration]

Secondary Outcome(s)

Concentration of Plasmin Inhibitor [Time Frame: From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis]

Secondary ID(s)

LAS-203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/05/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01063595