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An Investigation of rhTPO With Different Frequencies in the Management of ITP

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ClinicalTrials.gov Identifier: NCT02139501
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : April 20, 2016
Sponsor:
Collaborators:
The First Affiliated Hospital of Dalian Medical University
Shandong Provincial Hospital
Information provided by (Responsible Party):
Ming Hou, Shandong University

Tracking Information
First Submitted Date  ICMJE May 13, 2014
First Posted Date  ICMJE May 15, 2014
Last Update Posted Date April 20, 2016
Study Start Date  ICMJE May 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
Early Response [ Time Frame: 14 days ]
response rate (CR+R) at the 14th day and the 14th week from the initial injection of rhTPO. CR is defined as platelet count ≥ 100×10^9/L, and R is defined as platelet count of >30 × 10^9/L with a least a doubling of the baseline value.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 13, 2014)
Safety [ Time Frame: 1 years ]
The type and frequency of therapy associated adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Investigation of rhTPO With Different Frequencies in the Management of ITP
Official Title  ICMJE A Randomized Study to Evaluate the Efficacy and Safety of Different Doses and Frequencies of Recombinant Human Thrombopoietin (rhTPO) in the Management of Primary Immune Thrombocytopenia (ITP)
Brief Summary The project was undertaking by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to study the efficacy and safety of different dose and frequency Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP)
Detailed Description

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 30 primary ITP adult patients from 3 medical centers in China. They will be randomly assigned in a 1:1:1 ratio into three groups .The patients in group A (total 10 patients) will receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days;The patients in group B will receive rhTPO at a dose of 300Units/kg ,one times every other day for 7 times.The patients in group C will receive rhTPO at a dose of 300Units/kg ,daily for 7 consecutive days .All the patients will follow with a flexible dosage depending on platelet count during the following 12 weeks.

Platelet counts, bleeding and other symptoms were evaluated before and after treatment, in order to evaluate the efficacy and safety of different dose and frequency Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP)

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Immune Thrombocytopenia
Intervention  ICMJE Drug: Recombinant Human Thrombopoietin (rhTPO)
rhTPO was given intravenously at a dose of300Units/kg ,daily for 14 consecutive days;at a dose of 300Units/kg ,one times every other day for 7 times; or at a dose of 300Units/kg ,daily for 7 consecutive days
Other Names:
  • tpiao
  • Recombinant Human Thrombopoietin
  • Recombinant Human TPO
Study Arms  ICMJE
  • Experimental: rhTPO, 300Units/kg ,daily for 14 consecutive days
    10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days
    Intervention: Drug: Recombinant Human Thrombopoietin (rhTPO)
  • Experimental: rhTPO, 300Units/kg ,one times every other day for 7 times
    10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,one times every other day for 7 times.
    Intervention: Drug: Recombinant Human Thrombopoietin (rhTPO)
  • Experimental: rhTPO, 300Units/kg ,daily for 7 consecutive days
    10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 7consecutive days.
    Intervention: Drug: Recombinant Human Thrombopoietin (rhTPO)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2016)
48
Original Estimated Enrollment  ICMJE
 (submitted: May 13, 2014)
30
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is ≥18 years old, may be male or female.
  2. Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
  3. Patients who have no response or relapsed after Corticosteroid.
  4. To show a platelet count < 30×10^9/L, and with bleeding manifestations.
  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 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 .
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02139501
Other Study ID Numbers  ICMJE ITP-Thrombopoietin
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ming Hou, Shandong University
Study Sponsor  ICMJE Shandong University
Collaborators  ICMJE
  • The First Affiliated Hospital of Dalian Medical University
  • Shandong Provincial Hospital
Investigators  ICMJE
Principal Investigator: Ming Hou, Dr Shandong University
PRS Account Shandong University
Verification Date November 2014

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