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

Idiopathic Thrombocytopenic Purpura Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770562
• Other study ID #: ML18542
• Status: Completed
• Phase: Phase 3
• First received: October 9, 2008
• Last updated: October 21, 2014
• Start date: July 2005
• Est. completion date: July 2008

Study information

• Verified date: October 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy:AIFA
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• rituximab

• Dexamethasone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 24	No
Secondary	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.	Week 4	No
Secondary	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.	Week 4	No