Recombinant Human Thrombopoietin in Combination With Rituximab in Immune Thrombocytopenia (ITP)

This study has been completed.
Sponsor:
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: April 18, 2016
Last verified: January 2012
  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: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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:


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 ]

Enrollment: 91
Study Start Date: June 2009
Study Completion Date: December 2013
Primary Completion Date: August 2013 (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:
  • Recombinant Human Thrombopoietin
  • Recombinant Human TPO
  • rhTPO combine with Rituximab
  • Recombinant Human Thrombopoietin combine with Rituximab
  • Recombinant Human TPO combine with Rituximab

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   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. 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 second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
  3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
  4. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  5. 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)
  6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
  7. 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.
  8. Patients who are deemed unsuitable for the study by the investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506414

Locations
China, Shandong
Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
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: April 18, 2016
Health Authority: China: Food and Drug Administration

Keywords provided by Shandong University:
Purpura
Idiopathic Thrombocytopenic Purpura

Additional relevant MeSH terms:
Purpura
Thrombocytopenia
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Blood Platelet Disorders
Thrombotic Microangiopathies
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 26, 2016