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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

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)

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Recombinant Human Thrombopoietin (rhTPO) Phase 3

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)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : May 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015


Arm Intervention/treatment
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
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

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.
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

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.
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Safety [ Time Frame: 1 years ]
    The type and frequency of therapy associated adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139501


Locations
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China, Shandong
Qilu Hospital, Shandong University
Jinan, Shandong, China, 250012
Sponsors and Collaborators
Shandong University
The First Affiliated Hospital of Dalian Medical University
Shandong Provincial Hospital
Investigators
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Principal Investigator: Ming Hou, Dr Shandong University
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Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT02139501    
Other Study ID Numbers: ITP-Thrombopoietin
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: November 2014
Keywords provided by Ming Hou, Shandong University:
Recombinant Human Thrombopoietin
Dose and frequency
Immune Thrombocytopenia
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations