Back to resultsAn Investigation of rhTPO With Different Frequencies in the Management of ITP
Primary Purpose
Immune Thrombocytopenia
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Recombinant Human Thrombopoietin (rhTPO)
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Recombinant Human Thrombopoietin, Dose and frequency, Immune Thrombocytopenia
Eligibility Criteria
Inclusion Criteria:
- Subject is ≥18 years old, may be male or female.
- Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
- Patients who have no response or relapsed after Corticosteroid.
- To show a platelet count < 30×10^9/L, and with bleeding manifestations.
- Willing and able to sign written informed consent.
Exclusion Criteria:
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
- Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
- Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
- Current HIV infection or hepatitis B virus or hepatitis C virus infections.
- 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)
- Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
- 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.
- Patients who are deemed unsuitable for the study by the investigator .
Sites / Locations
- Qilu Hospital, Shandong University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
rhTPO, 300Units/kg ,daily for 14 consecutive days
rhTPO, 300Units/kg ,one times every other day for 7 times
rhTPO, 300Units/kg ,daily for 7 consecutive days
Arm Description
10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days
10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,one times every other day for 7 times.
10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 7consecutive days.
Outcomes
Primary Outcome Measures
Early Response
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
Safety
The type and frequency of therapy associated adverse events
Full Information
NCT ID
NCT02139501
First Posted
May 13, 2014
Last Updated
April 18, 2016
Sponsor
Shandong University
Collaborators
The First Affiliated Hospital of Dalian Medical University, Shandong Provincial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02139501
Brief Title
An Investigation of rhTPO With Different Frequencies in the Management of ITP
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 Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
Collaborators
The First Affiliated Hospital of Dalian Medical University, Shandong Provincial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
Recombinant Human Thrombopoietin, Dose and frequency, Immune Thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rhTPO, 300Units/kg ,daily for 14 consecutive days
Arm Type
Experimental
Arm Description
10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days
Arm Title
rhTPO, 300Units/kg ,one times every other day for 7 times
Arm Type
Experimental
Arm Description
10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,one times every other day for 7 times.
Arm Title
rhTPO, 300Units/kg ,daily for 7 consecutive days
Arm Type
Experimental
Arm Description
10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 7consecutive days.
Intervention Type
Drug
Intervention Name(s)
Recombinant Human Thrombopoietin (rhTPO)
Other Intervention Name(s)
tpiao, Recombinant Human Thrombopoietin, Recombinant Human TPO
Intervention Description
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
Primary Outcome Measure Information:
Title
Early Response
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Safety
Description
The type and frequency of therapy associated adverse events
Time Frame
1 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject is ≥18 years old, may be male or female.
Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
Patients who have no response or relapsed after Corticosteroid.
To show a platelet count < 30×10^9/L, and with bleeding manifestations.
Willing and able to sign written informed consent.
Exclusion Criteria:
Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
Current HIV infection or hepatitis B virus or hepatitis C virus infections.
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)
Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
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.
Patients who are deemed unsuitable for the study by the investigator .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Hou, Dr
Organizational Affiliation
Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
12. IPD Sharing Statement
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An Investigation of rhTPO With Different Frequencies in the Management of ITP
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