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OpenTrials
Completed

NCT Number: NCT00770562

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

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.

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Key information

Conditions

Idiopathic Thrombocytopenic Purpura Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bari, Italy

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rituximab

Drug

Other names: MabThera/Rituxan

Dexamethasone

Drug

Primary outcomes

  1. Percentage of Participants With a Sustained Response

    Time frame: Week 24

    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.

Secondary outcomes

  1. Percentage of Participants With an Initial Response

    Time frame: Week 4

    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.

  2. Percentage of Participants With an Initial Complete Response

    Time frame: Week 4

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Oct 10, 2008
Registry last updated
Oct 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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