Trial information
A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
Status: Recruiting
Protocol number: ML20948
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official 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.
Brief summary: This single arm study will evaluate the efficacy and safety of MabThera monotherapy in patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP). Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 106.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Idiopathic Thrombocytopenic Purpura
Intervention type: Drug
Intervention name: rituximab [MabThera/Rituxan]
Primary outcome: 1. Overall response rate Time frame: Week 8
Key secondary outcomes: 1. Time to CR and PR; CR and PR rates; duration of response; time to new therapy. Time frame: Event driven
2. AEs, hematological toxicity, infections, infusion reactions. Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: May, 2007
Trial registration date: 05/17/2007
Date last updated: 8/19/2008
Link to trial result
This trial is being conducted at the following locations:
Australia
- Adelaide
- Frankston
- Gosford
- Malvern
- Melbourne
- Parkville
- Randwick
- Sydney
- Westmead
- Woolloongabba
