Idiopathic Thrombocytopenic Purpura Clinical Trial
Official title:
Recombinant Human Thrombopoietin in Combination With Rituximab Versus Low-dose Rituximab for the Treatment of Refractory ITP.
Verified date | May 2013 |
Source | Shandong University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Ministry of Health |
Study type | Interventional |
The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining with Rituximab for the treatment of adults with refractory immune thrombocytopenia (ITP), compared to conventional Rituximab therapy.
Status | Completed |
Enrollment | 123 |
Est. completion date | June 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 72 Years |
Eligibility |
Inclusion Criteria: 1. Meet the diagnostic criteria for immune thrombocytopenia. 2. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years. 3. To show a platelet count < 30×10^9/L, and with bleeding manifestations. 4. Eastern Cooperative Oncology Group(ECOG)performance status = 2. 5. Willing and able to sign written informed consent Exclusion Criteria: 1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. 2. Received high-dose steroids or [2] intravenous immunoglobulin transfusion(IVIG)in the 3 weeks prior to the start of the study. 3. Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than ITP. 4.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 5.Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 6.Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test. 7.Patients who are deemed unsuitable for the study by the investigator. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Qilu Hospital, Shandong University | Jinan | Shandong |
Lead Sponsor | Collaborator |
---|---|
Shandong University | First Hospital of China Medical University, Shandong Provincial Hospital, Shenzhen Second People's Hospital, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Dalian Medical University |
China,
Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003 Aug 28;349(9):831-6. — View Citation
Mazzucconi MG, Fazi P, Bernasconi S, De Rossi G, Leone G, Gugliotta L, Vianelli N, Avvisati G, Rodeghiero F, Amendola A, Baronci C, Carbone C, Quattrin S, Fioritoni G, D'Alfonso G, Mandelli F; Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Thrombocytopenia Working Party. Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood. 2007 Feb 15;109(4):1401-7. Epub 2006 Oct 31. — View Citation
Medeot M, Zaja F, Vianelli N, Battista M, Baccarani M, Patriarca F, Soldano F, Isola M, De Luca S, Fanin R. Rituximab therapy in adult patients with relapsed or refractory immune thrombocytopenic purpura: long-term follow-up results. Eur J Haematol. 2008 Sep;81(3):165-9. doi: 10.1111/j.1600-0609.2008.01100.x. Epub 2008 May 27. — View Citation
Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21. Review. — View Citation
Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kühne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of platelet response (Complete Response) | CR. A complete response (CR) was defined as a sustained (= 3 months) platelet count = 100×10^9/L | The time frame is up to 3 months per subject | Yes |
Primary | Evaluation of platelet response (Response) | R. A response (R) was defined as a sustained (= 3 months) platelet count = 30×10^9/L without recurrence of thrombocytopenia. | The time frame is up to 3 months per subject | Yes |
Primary | Evaluation of platelet response (No Response) | NR.No response (NR) was defined as platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart. | The time frame is up to 3 months per subject | Yes |
Primary | Evaluation of platelet response (relapses) | A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR. | The time frame is up to 3 months per subject | Yes |
Secondary | The number and frequency of therapy associated adverse events | up to 3 months per subject | Yes |
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