A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Shandong University
Sponsor:
Collaborators:
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Anhui Medical University
The First Affiliated Hospital of Dalian Medical University
Shandong Provincial Hospital
Shenzhen Second People's Hospital
China Medical University, China
Information provided by (Responsible Party):
Ming Hou, Shandong University
ClinicalTrials.gov Identifier:
NCT01525836
First received: January 31, 2012
Last updated: May 4, 2013
Last verified: May 2013
  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
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.

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

  • 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.


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: 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:
  • Recombinant Human Thrombopoietin
  • Recombinant Human TPO
  • rhTPO combine with Rituximab
  • Recombinant Human Thrombopoietin combine with Rituximab
  • Recombinant Human TPO combine with Rituximab
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)

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
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. 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.

  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: NCT01525836

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
Contact: Ming Hou, Dr.    +86-531-82169114 ext 9879    houming@medmail.com.cn   
Principal Investigator: Ming Hou, Dr.         
Sponsors and Collaborators
Shandong University
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Anhui Medical University
The First Affiliated Hospital of Dalian Medical University
Shandong Provincial Hospital
Shenzhen Second People's Hospital
China Medical University, China
Investigators
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:
Purpura
Idiopathic Thrombocytopenic Purpura

Additional relevant MeSH terms:
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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 28, 2014