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

NCT01063595 | Completed Phase 1 Results

• 1 other identifier: LAS-203
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters. The secondary objective of the study was to compare the safety and tolerability of Octaplas LG with Octaplas SD in terms of haematological and clinical chemistry parameters and adverse event monitoring.

Conditions

Comparison of Octaplas LG and Octaplas SD

Keywords

Octaplas LG; Octaplas SD

Outcome Measures

Primary Outcomes (2)

• Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI

  Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.

  From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration

• Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C

  Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.

  From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration

Secondary Outcomes (1)

• Concentration of Plasmin Inhibitor

  From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis

Study Arms (2)

Octaplas LG

EXPERIMENTAL

Participants received 1200 mL of Octaplas LG intravenously once.

Biological: Octaplas LG

Octaplas SD

ACTIVE COMPARATOR

Participants received 1200 mL of Octaplas SD intravenously once.

Biological: Octaplas SD

Interventions

Octaplas LG BIOLOGICAL

Octaplas LG was composed of human coagulation-active plasma treated with solvent/detergent for 1-1.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. An additional manufacturing step, involving an affinity ligand gel, removed prion proteins. Octaplas LG was provided frozen in pyrogen free plastic bags.

Octaplas LG

Octaplas SD BIOLOGICAL

Octaplas SD was composed of human coagulation-active plasma treated with solvent/detergent for 4-4.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. Octaplas SD was provided frozen in pyrogen free plastic bags.

Octaplas SD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Octapharma: lead

Study Sites (1)

Department of Clinical Pharmacology - Medical University Vienna

Vienna, Austria

Location

Related Publications (1)

• Jilma-Stohlawetz P, Kursten FW, Horvath M, Leitner G, List J, Marcek J, Quehenberger P, Schwameis M, Bartko J, Derhaschnig U, Jilma B. Recovery, safety, and tolerability of a solvent/detergent-treated and prion-safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers. Transfusion. 2013 Sep;53(9):1906-17. doi: 10.1111/trf.12075. Epub 2013 Jan 16.

  PMID: 23320451 DERIVED

Results Point of Contact

• Title: Michael Eppolito, Director, Clinical Operations Immunology and ICU Medicine
• Organization: Octapharma USA

michael.eppolito@octapharma.com

201 604-1155

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: December 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: May 20, 2014
• Results First Posted: May 1, 2014

Record last verified: 2014-05

Locations

AU (1)