A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
NCT ID: NCT00770562
Last Updated: 2014-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
103 participants
INTERVENTIONAL
2005-07-31
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dexamethasone
Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10\^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m\^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
Dexamethasone
Dexamethasone plus Rituximab
Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (\<) 20 x10\^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
rituximab
Dexamethasone
Interventions
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rituximab
Dexamethasone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* untreated ITP.
Exclusion Criteria
* positive test result for HIV or hepatitis B or C;
* active infection requiring systemic therapy;
* malignancy within 3 years before study.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Bari, , Italy
Bologna, , Italy
Brescia, , Italy
Cagliari, , Italy
Cuneo, , Italy
Genova, , Italy
Milan, , Italy
Napoli, , Italy
Padua, , Italy
Palermo, , Italy
Pavia, , Italy
Pesaro, , Italy
Pescara, , Italy
Ravenna, , Italy
Reggio Emilia, , Italy
Roma, , Italy
Roma, , Italy
Roma, , Italy
Siena, , Italy
Taranto, , Italy
Udine, , Italy
Verona, , Italy
Countries
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References
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Zaja F, Baccarani M, Mazza P, Bocchia M, Gugliotta L, Zaccaria A, Vianelli N, Defina M, Tieghi A, Amadori S, Campagna S, Ferrara F, Angelucci E, Usala E, Cantoni S, Visani G, Fornaro A, Rizzi R, De Stefano V, Casulli F, Battista ML, Isola M, Soldano F, Gamba E, Fanin R. Dexamethasone plus rituximab yields higher sustained response rates than dexamethasone monotherapy in adults with primary immune thrombocytopenia. Blood. 2010 Apr 8;115(14):2755-62. doi: 10.1182/blood-2009-07-229815. Epub 2010 Feb 3.
Other Identifiers
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ML18542
Identifier Type: -
Identifier Source: org_study_id
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