A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

Hoffmann-La Roche103 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

103

Conditions

Idiopathic Thrombocytopenic Purpura

Interventions

rituximabDRUG

DexamethasoneDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (22)

Unnamed facility

Bari, Italy

Unnamed facility

Bologna, Italy

Unnamed facility

Brescia, Italy

Outcomes

Primary Outcomes

Percentage of Participants With a Sustained Response

Sustained response defined as a platelet count of greater than or equal to (≥) 50x10\^9/L at 6 months (Week 24) after the initial treatment. Participants failing therapy before Month 6 (Week 24) and treated in other ways were considered failures.

Time frame: Week 24

Secondary Outcomes

Percentage of Participants With an Initial Response

Initial response was defined as an increase in platelet count of ≥50x10\^9/L by Day 30 (Week 4) after the start of treatment in either treatment arm.

Time frame: Week 4

Percentage of Participants With an Initial Complete Response

Initial complete response was defined as an increase in platelet count of ≥100x10\^9/L by Day 30 (Week 4) after the initiation of treatment in either treatment arm.

Time frame: Week 4

Data from ClinicalTrials.gov

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