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

January 31, 2012
May 4, 2013
May 2011
September 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01525836 on ClinicalTrials.gov Archive Site
The number and frequency of therapy associated adverse events [ Time Frame: up to 3 months per subject ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP)
Recombinant Human Thrombopoietin in Combination With Rituximab Versus Low-dose Rituximab for the Treatment of Refractory ITP.

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Purpura
  • Idiopathic Thrombocytopenic Purpura
  • 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
  • Drug: Rituximab
    patients in recombinant treatment group take Rituximab intravenously at 100 mg weekly for 4 consecutive weeks(Day 1,8,15,22)
  • Experimental: combination treatment group
    120 enrolled patients are randomly picked up to take Rituximab in combination with Rh-TPO at the indicated dose.
    Intervention: Drug: rituximab; recombinant human thrombopoietin (rhTPO)
  • Active Comparator: single treatment group
    120 enrolled patients are randomly picked up to take Rituximab at the indicated dose.
    Intervention: Drug: Rituximab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
December 2013
September 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years to 72 Years
No
Contact: Ming Hou, Dr. +86-531-82169114 ext 9879 houming@medmail.com.cn
China
 
NCT01525836
ITP-004
Yes
Ming Hou, Shandong University
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
Principal Investigator: Minf Hou, Dr. Shandong University
Shandong University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP