Safety and Efficacy Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)

NCT00411801 | Terminated Phase 3 DMC

• 1 other identifier: UNI-108
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Prior to the use of plasma products, thrombotic thrombocytopenic purpura (TTP) was usually a fatal condition. During plasma exchange therapy, patients need transfusion plasma that is blood group specific. Transfusing a patient with an incorrect blood group may have fatal consequences. Uniplas is a universally applicable human plasma, which can be administered irrespective of the patient's blood group. This study will test the safety and efficacy of Uniplas in comparison to cryosupernatant plasma in treatment of patients with TTP.

Conditions

Thrombotic Thrombocytopenic Purpura (TTP)

Keywords

bleeding disorder; universal plasma; plasma; plasma exchange

Outcome Measures

Primary Outcomes (1)

• Change from baseline in (log) platelet count 1 month after treatment initiation

  Log platelet count was reported in units, where 1 unit = 10\^9/L platelets.

  Baseline to Month 1

Secondary Outcomes (5)

• Percentage of participants who died at 1 and 3 months after treatment initiation

  Baseline to Month 3

• Percentage of participants with a complete response (CR), a partial response (PR), a non-response (NR), or a transient response (TR) after the first treatment cycle and at 1 month

  Baseline to Month 1

• Total volume of plasma exchange fluid administered during treatment cycles up to 1 month

  Baseline to Month 1

• Time to reach maximum platelet count

  Baseline to the end of the study (up to 7 months)

• Best clinical response (complete response [CR], partial response [PR], non-response [NR], transient response [TR]) during the study

  Baseline to the end of the study (up to 7 months)

Study Arms (2)

Uniplas

EXPERIMENTAL

Participants will receive Uniplas intravenously in 4 cycles of 7 to 9 days each for 1 month. The first cycle will consist of 1.5 plasma volume exchanges (= 75 mL/kg) for 3 consecutive days, followed by a minimum of 4 and a maximum of 6 daily single volume plasma exchanges (= 50 mL/kg). Subsequent treatment will depend upon the response of the participant to the first cycle, as assessed by a blinded assessor.

Biological: Uniplas

Cryosupernatant plasma

ACTIVE COMPARATOR

Participants will receive cryosupernatant plasma intravenously in 4 cycles of 7 to 9 days each for 1 month. The first cycle will consist of 1.5 plasma volume exchanges (= 75 mL/kg) for 3 consecutive days, followed by a minimum of 4 and a maximum of 6 daily single volume plasma exchanges (= 50 mL/kg). Subsequent treatment will depend upon the response of the participant to the first cycle, as assessed by a blinded assessor.

Biological: Cryosupernatant plasma

Interventions

Uniplas BIOLOGICAL

Uniplas will be provided frozen in sterile plastic bags.

Also known as: Blood group independent, universally applicable, prion-depleted, solvent/detergent treated, human pooled plasma

Uniplas

Cryosupernatant plasma BIOLOGICAL

Cryosupernatant plasma will be provided frozen in sterile plastic bags.

Cryosupernatant plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and above.
• Definite diagnosis of acute thrombotic thrombocytopenic purpura (TTP).
• Thrombocytopenia.
• Diagnostic signs of microangiopathic hemolytic anemia.

You may not qualify if:

• Congenital thrombotic microangiopathies.
• Alternative secondary cause for microangiopathy.
• Co-morbid illness limiting life expectancy to less than 3 months independent of TTP.
• Patients known to be HIV positive.
• Patients known to have lupus.
• Refusal to accept blood products.

Sponsors & Collaborators

• Octapharma: lead

Study Sites (1)

Contact Octapharma for Facility Details

Centreville, Virginia, 20120, United States

Location

MeSH Terms

Conditions

Purpura, Thrombotic Thrombocytopenic; Hemostatic Disorders

Interventions

Solvents

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Thrombophilia; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Wolfgang Frenzel, M.D.

  Octapharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2006
• First Posted: December 15, 2006
• Study Start: May 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: June 21, 2017

Record last verified: 2017-06

Locations

US (1)