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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00411801
• Date of registration: 13/12/2006
• Prospective Registration: Yes
• Primary sponsor: Octapharma
• Public title: Safety and Efficacy Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)
• Scientific title: A Blinded Non-inferiority Study to Compare Uniplas With Cryosupernatant Plasma in Thrombotic Thrombocytopenic Purpura (TTP)
• Date of first enrolment: May 2007
• Target sample size: 8
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00411801
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Wolfgang Frenzel, M.D.
• Affiliation: Octapharma

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18 years of age and above.

- Definite diagnosis of acute thrombotic thrombocytopenic purpura (TTP).

- Thrombocytopenia.

- Diagnostic signs of microangiopathic hemolytic anemia.

Exclusion Criteria:

- 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.



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

Health Condition(s) or Problem(s) studied

Thrombotic Thrombocytopenic Purpura (TTP)

Intervention(s)

Biological: Uniplas

Biological: Cryosupernatant plasma

Primary Outcome(s)

Change from baseline in (log) platelet count 1 month after treatment initiation [Time Frame: Baseline to Month 1]

Secondary Outcome(s)

Percentage of participants who died at 1 and 3 months after treatment initiation [Time Frame: Baseline to Month 3]

Total volume of plasma exchange fluid administered during treatment cycles up to 1 month [Time Frame: Baseline to Month 1]

Best clinical response (complete response [CR], partial response [PR], non-response [NR], transient response [TR]) during the study [Time Frame: Baseline to the end of the study (up to 7 months)]

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 [Time Frame: Baseline to Month 1]

Time to reach maximum platelet count [Time Frame: Baseline to the end of the study (up to 7 months)]

Secondary ID(s)

UNI-108

Source(s) of Monetary Support

Please refer to primary and secondary sponsors