Recombinant Human Thrombopoietin in Combination With Rituximab in Immune Thrombocytopenia (ITP)
This study is currently recruiting participants.
Verified January 2012 by Shandong University
Sponsor:
Ming Hou
Collaborators:
Peking Union Medical College Hospital
Chinese Academy of Medical Sciences
First Affiliated Hospital, Sun Yat-Sen University
West China Hospital
Shandong Provincial Hospital
Wuhan Union Hospital, China
Zhejiang University
Information provided by (Responsible Party):
Ming Hou, Shandong University
ClinicalTrials.gov Identifier:
NCT01506414
First received: November 16, 2011
Last updated: January 20, 2012
Last verified: January 2012
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Purpose
The purpose of this study is to determine whether Recombinant Human Thrombopoietin (rh-TPO) in combination with Rituximab are effective and safe in the management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).
| Condition | Intervention | Phase |
|---|---|---|
|
Purpura Idiopathic Thrombocytopenic Purpura |
Drug: rhTPO in combination with Rituximab |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | A Multicentre Investigation of Recombinant Human Thrombopoietin (Rh-TPO) Combine With Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP) |
Resource links provided by NLM:
Genetics Home Reference related topics:
thrombotic thrombocytopenic purpura
Drug Information available for:
Rituximab
U.S. FDA Resources
Further study details as provided by Shandong University:
Primary Outcome Measures:
- 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 without recurrence of thrombocytopenia
- Evaluation of platelet response (R) [ 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.
Secondary Outcome Measures:
- The number and frequency of therapy associated adverse events [ Time Frame: up to 3 months per subject ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: combination treatment |
Drug: rhTPO in combination with Rituximab
Rituximab was given intravenously at a dose of 100 mg weekly for 4 consecutive weeks (Day 1, 8, 15, 22). Rh-TPO (TPIAOTM, a product of Sunshine Pharmaceutical Co Ltd, China, approved by China State Food and Drug Administration) was given subcutaneously at a dose of 1.0 μg/kg（300u/kg）for 14 days (Day 1-14).
Other Names:
|
Detailed Description:
Rituximab was given intravenously at a dose of 100 mg weekly for 4 consecutive weeks (Day 1, 8, 15, 22). Rh-TPO (TPIAOTM, a product of Sunshine Pharmaceutical Co Ltd, China, approved by China State Food and Drug Administration) was given subcutaneously at a dose of 1.0 μg/kg（300u/kg）for 14 days (Day 1-14). Platelet count (PC) was monitored every three or four days until day 22, followed by tests every week. Platelet transfusion was administered to patients with active bleeding symptoms or to those whose PC<10×10^9/L. Patients were followed for 3 months, and any adverse effects were recorded during the period of treatment and during the follow-up.
Eligibility| Ages Eligible for Study: | 16 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
- 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 second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
- Received high-dose steroids or 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 chronic 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)
- Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- 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.
- Patients who are deemed unsuitable for the study by the investigator.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506414
Contacts
| Contact: Ming Hou, Dr. | +86-531-82169114 ext 9879 | houming@medmail.com.cn |
Locations
| China, Shandong | |
| Qilu Hospital, Shandong University | Recruiting |
| Jinan, Shandong, China, 250012 | |
| Contact: Peng Jun, Dr. +8613553157577 junpeng88@sina.com | |
Sponsors and Collaborators
Ming Hou
Peking Union Medical College Hospital
Chinese Academy of Medical Sciences
First Affiliated Hospital, Sun Yat-Sen University
West China Hospital
Shandong Provincial Hospital
Wuhan Union Hospital, China
Zhejiang University
Investigators
| Principal Investigator: | Hou Ming, Dr. | Shandong University |
More Information
Publications:
| Responsible Party: | Ming Hou, Director of Hematology Department, Shandong University |
| ClinicalTrials.gov Identifier: | NCT01506414 History of Changes |
| Other Study ID Numbers: | ITP-003 |
| Study First Received: | November 16, 2011 |
| Last Updated: | January 20, 2012 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Shandong University:
|
Purpura Idiopathic Thrombocytopenic Purpura |
Additional relevant MeSH terms:
|
Purpura Purpura, Thrombocytopenic Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic Blood Coagulation Disorders Hematologic Diseases Hemorrhage Pathologic Processes Skin Manifestations Signs and Symptoms Thrombotic Microangiopathies |
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