A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00475423
• Date of registration: 17/05/2007
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
• Scientific title: An Open Label Study of a Fixed Dose Regimen of MabThera on Overall Response Rate in Patients With Refractory, Relapsing or Chronic Idiopathic Thrombocytopenic Purpura.
• Date of first enrolment: May 2007
• Target sample size: 122
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00475423
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Australia

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- adult patients, >=18 years of age;

- refractory, relapsing or chronic idiopathic thrombocytopenic purpura;

- stable therapy during 3 weeks prior to study entry.

Exclusion Criteria:

- newly diagnosed ITP (<6 weeks);

- prior treatment with MabThera;

- active bleeding requiring platelet transfusion within 7 days prior to entry into
study.



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

Health Condition(s) or Problem(s) studied

Idiopathic Thrombocytopenic Purpura

Intervention(s)

Drug: rituximab [MabThera/Rituxan]

Primary Outcome(s)

Percentage of Participants Achieving a Complete Hematological Response (CR) or Confirmed Partial Hematological Response (PR) [Time Frame: Week 8]

Secondary Outcome(s)

Time to Initiation of New ITP Therapy [Time Frame: Baseline to Week 52]

Percentage of Participants Who Achieved PR [Time Frame: Week 52]

Percentage of Therapeutic Responders [Time Frame: Week 26 and Week 52]

Percentage of Participants Who Achieved MR [Time Frame: Week 52]

Percentage of Participants With Continued CR From Week 8 to Week 52 [Time Frame: Week 8 to Week 52]

Duration of PR in Participants With Continued PR From Week 8 Until Week 52 [Time Frame: Week 8 to Week 52]

Percentage of Participants With a Therapeutic Response [Time Frame: Week 26 and Week 52]

Percentage of Participants With Hematological CR, PR, or Minor Response (MR) [Time Frame: Week 8]

Time to CR [Time Frame: Baseline to Week 52]

Duration of CR in Participants With Continued CR From Week 8 Until Week 52 [Time Frame: Week 8 to Week 52]

Duration of MR in Participants With Continued MR From Week 8 Until Week 52 [Time Frame: Week 8 to Week 52]

Percentage of Participants Who Achieved CR [Time Frame: Week 52]

Time to Inititiation of New ITP Therapy - Percentage of Participants With an Event [Time Frame: Week 52]

Time to PR [Time Frame: Baseline to Week 52]

Time to MR [Time Frame: Baseline to Week 52]

Change From Baseline in CD19 B Cell Count [Time Frame: Weeks 3, 8 and Months 4, 6, 8, 10 and 12, and last day]

Cluster of Differentiation 19 (CD19) B Cell Count [Time Frame: Baseline, Weeks 1, 3, and 8, Follow-up Months 4, 6, 8, 10, and 12, and Last Day]

Secondary ID(s)

ML20948

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/02/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00475423