Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

Phase 3

Withdrawn

• Conditions: Purpura; Idiopathic Thrombocytopenic Purpura
• Interventions: Drug: recombinant human thrombopoietin (rhTPO); rituximab; Drug: Dexamethasone

• Registration Number: NCT01734057
• Lead Sponsor: Shandong University

Brief Summary

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 primary immune thrombocytopenia (ITP), compared to conventional high-dose dexamethasone therapy.

Detailed Description

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 240 primary 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 300Units/kgfor 14 consecutive days, following with a flexible dosage depending on platelet count until the 28th 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 high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4 days). Platelet count was evaluated before and after treatment,in order to report the conversion ratio of primary ITP to chronic ITP.

Study Timeline

• Study Start: 2012-07
• Status Verified: 2012-11
• Study First Submitted: 2012-11-21
• Study First Submitted QC: 2012-11-21
• Study First Posted: 2012-11-27
• Primary Completion: 2013-07
• Study Completion: 2013-10
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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 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.
4. Severe medical condition (lung, hepatic or renal disorder) other than ITP. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
combinant treatment group	recombinant human thrombopoietin (rhTPO); rituximab	120 enrolled patients are randomly picked up to take Rituximab in combination with rhTPO at the indicated dose.
single treatment group	Dexamethasone	120 enrolled patients are randomly picked up to take dexamethasone at the indicated dose.

Primary Outcome Measures

Name	Time	Method
Evaluation of platelet response (Complete Response)	up to 1 year per subject	CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10\^9/L without recurrence of thrombocytopenia
Evaluation of platelet response(Chronic ITP)	up to 1 year per subject	Chronic ITP is defined as having platelet count less than 100×10\^9/L,lasting for more than 12 months.
Evaluation of platelet response (R)	up to 1 year per subject	R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10\^9/L without recurrence of thrombocytopenia

Trial Locations

Locations (1)

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China