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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00770562
First received: October 9, 2008
Last updated: October 7, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Idiopathic Thrombocytopenic Purpura
Drug: rituximab
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained response 6 months after initial treatment\n [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Initial response by day 30 after initiation of treatment; incidence of serious and life-threatening adverse events\n [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: July 2005
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab
1
Other Name: MabThera/Rituxan

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770562

Locations
Italy
Bari, Italy, 70124
Bologna, Italy, 40138
Brescia, Italy, 25123
Cagliari, Italy, 09121
Cuneo, Italy, 12100
Genova, Italy, 16132
Milano, Italy, 20162
Napoli, Italy, 80131
Padova, Italy, 35128
Palermo, Italy, 90146
Pavia, Italy, 27100
Pesaro, Italy, 61100
Pescara, Italy, 65100
Ravenna, Italy, 48100
Reggio Emilia, Italy, 42100
Roma, Italy, 00168
Roma, Italy, 00161
Roma, Italy, 00133
Siena, Italy, 53100
Taranto, Italy, 74100
Udine, Italy, 33100
Verona, Italy, 37130
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00770562     History of Changes
Other Study ID Numbers: ML18542
Study First Received: October 9, 2008
Last Updated: October 7, 2013
Health Authority: Italy:AIFA

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014