A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
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Purpura Idiopathic Thrombocytopenic Purpura |
Drug: rituximab; recombinant human thrombopoietin (rhTPO) Drug: Rituximab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Recombinant Human Thrombopoietin in Combination With Rituximab Versus Low-dose Rituximab for the Treatment of Refractory ITP. |
- Evaluation of platelet response (Complete Response) [ Time Frame: The time frame is up to 3 months per subject ] [ Designated as safety issue: Yes ]CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L
- Evaluation of platelet response (Response) [ Time Frame: The time frame is up to 3 months per subject ] [ Designated as safety issue: Yes ]R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.
- Evaluation of platelet response (No Response) [ Time Frame: The time frame is up to 3 months per subject ] [ Designated as safety issue: Yes ]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.
- Evaluation of platelet response (relapses) [ Time Frame: The time frame is up to 3 months per subject ] [ Designated as safety issue: Yes ]A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.
- The number and frequency of therapy associated adverse events [ Time Frame: up to 3 months per subject ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 240 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: combination treatment group
120 enrolled patients are randomly picked up to take Rituximab in combination with Rh-TPO at the indicated dose.
|
Drug: rituximab; recombinant human thrombopoietin (rhTPO)
patients in recombination treatment group take Rituximab( intravenously ,100 mg weekly for 4 consecutive weeks); in combination with Rh-TPO( subcutaneously , 300U/kg for 14 consecutive days,followed by flexible treating dosage so as to keep the platelet count above 50×10^9/L until the 29th day)
Other Names:
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Active Comparator: single treatment group
120 enrolled patients are randomly picked up to take Rituximab at the indicated dose.
|
Drug: Rituximab
patients in recombinant treatment group take Rituximab intravenously at 100 mg weekly for 4 consecutive weeks（Day 1,8,15,22)
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Detailed Description:
The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 240 refractory ITP adult patients from 14 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300 Units/kg for 14 consecutive days,following with a flexible dosage depending on platelet count until the 29th day), combining with rituximab (given intravenously at a dose of 100 mg weekly for 4 weeks, i.e. Day 1, 8, 15, 22; the others are selected to receive low-dose of rituximab treatment (given intravenously at a dose of 100 mg weekly, i.e. Day 1, 8, 15, 22). Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of the combination therapy compared to conventional rituximab therapy for the treatment of adults with refractory ITP.
Eligibility| Ages Eligible for Study: | 18 Years to 72 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Meet the diagnostic criteria for immune thrombocytopenia.
- Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years.
- To show a platelet count < 30×10^9/L, and with bleeding manifestations.
- Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
- Willing and able to sign written informed consent
Exclusion Criteria:
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- Received high-dose steroids or [2] intravenous immunoglobulin transfusion(IVIG)in the 3 weeks prior to the start of the study.
- 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.
Contacts and Locations| Contact: Ming Hou, Dr. | +86-531-82169114 ext 9879 | houming@medmail.com.cn |
| China, Shandong | |
| Qilu Hospital, Shandong University | Recruiting |
| Jinan, Shandong, China | |
| Contact: Ming Hou, Dr. +86-531-82169114 ext 9879 houming@medmail.com.cn | |
| Principal Investigator: Ming Hou, Dr. | |
| Principal Investigator: | Minf Hou, Dr. | Shandong University |
More Information
Publications:
| Responsible Party: | Ming Hou, Professor and Director, Shandong University |
| ClinicalTrials.gov Identifier: | NCT01525836 History of Changes |
| Other Study ID Numbers: | ITP-004 |
| Study First Received: | January 31, 2012 |
| Last Updated: | May 4, 2013 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Shandong University:
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Purpura Idiopathic Thrombocytopenic Purpura |
Additional relevant MeSH terms:
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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 Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 16, 2013