Trial information
A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
Status: Completed
Protocol number: ML18542
Sponsor: Roche S.p.A.
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of first-line treatment with dexamethasone or dexamethasone plus MabThera on sustained treatment response in adult patients with idiopathic thrombocytopenic purpura
Brief summary: This study will compare the efficacy, safety, and pharmacokinetics of standard treatment versus standard treatment plus MabThera in patients with ITP. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.
Target sample size is
103.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Idiopathic Thrombocytopenic Purpura
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. Sustained response 6 months after initial treatment
Key secondary outcomes: 1. Initial response by day 30 after initiation of treatment; incidence of serious and life-threatening adverse events
Inclusion criteria:
- adult patients >=18 years of age;
- untreated ITP.
Exclusion criteria:
- ITP with relapse;
- positive test result for HIV or hepatitis B or C;
- active infection requiring systemic therapy;
- malignancy within 3 years before study.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 10/27/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Italy
- Bari
- Bologna
- Brescia
- Cagliari
- Cuneo
- Milano
- Napoli
- Padova
- Palermo
- Pesaro
- Pescara
- Ravenna
- Reggio Emilia
- Roma
- Siena
- Taranto
- Udine
- Verona
