Back to resultsA Multicenter Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）
Primary Purpose
Immune Thrombocytopenia
Status
Withdrawn
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Cyclosporin A
rhTPO
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Immune Thrombocytopenia, Recombinant Human Thrombopoietin, Cyclosporin A
Eligibility Criteria
Inclusion Criteria:
- Meet the diagnostic criteria for immune thrombocytopenia.
- Steroid-resistant/relapsed hospitalized patients, may be male or female, between the ages of 18-80 years.
- To show a platelet count < 30×10^9/L, and with bleeding manifestations.
- Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
- 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.
- Current HIV infection or hepatitis B virus or hepatitis C virus infections. 3.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.
Sites / Locations
- Qilu Hospital, Shandong University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
combination treatment group
single treatment group
Arm Description
60 enrolled patients are randomly picked up to take cyclosporin A in combination with rhTPO at the indicated dose.
60 enrolled patients are randomly picked up to take cyclosporin A at the indicated dose.
Outcomes
Primary Outcome Measures
Evaluation of platelet response (Complete Response)
CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L
Evaluation of platelet response (Response)
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)
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)
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 The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02203422
Brief Title
A Multicenter Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）
Official Title
Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Withdrawn
Why Stopped
No eligible patient was enrolled.
Study Start Date
July 2014 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shandong University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The project was undertaking by Qilu Hospital of Shandong University and other 5 well-known hospitals in China. In order to report the efficacy and safety of recombinant human thrombopoietin combining with cyclosporin A for the treatment of adults with refractory immune thrombocytopenia (ITP), compared to cyclosporin A monotherapy.
Detailed Description
The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 120 steroid-resistant/relapsed ITP adult patients from 6 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 cyclosporin A (given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients achieved a complete response). The others are selected to receive cyclosporin A monotherapy (given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients achieved a complete response). 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 cyclosporin A monotherapy for the treatment of adults with steroid-resistant/relapsed ITP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
Keywords
Immune Thrombocytopenia, Recombinant Human Thrombopoietin, Cyclosporin A
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
combination treatment group
Arm Type
Experimental
Arm Description
60 enrolled patients are randomly picked up to take cyclosporin A in combination with rhTPO at the indicated dose.
Arm Title
single treatment group
Arm Type
Active Comparator
Arm Description
60 enrolled patients are randomly picked up to take cyclosporin A at the indicated dose.
Intervention Type
Drug
Intervention Name(s)
Cyclosporin A
Intervention Description
given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients achieved a complete response.
Intervention Type
Drug
Intervention Name(s)
rhTPO
Intervention Description
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
Primary Outcome Measure Information:
Title
Evaluation of platelet response (Complete Response)
Description
CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L
Time Frame
The time frame is up to 3 months per subject
Title
Evaluation of platelet response (Response)
Description
R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.
Time Frame
The time frame is up to 3 months per subject
Title
Evaluation of platelet response (No Response)
Description
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.
Time Frame
The time frame is up to 3 months per subject
Title
Evaluation of platelet response (relapses)
Description
A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.
Time Frame
The time frame is up to 3 months per subject
Secondary Outcome Measure Information:
Title
The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events The number and frequency of therapy associated adverse events
Time Frame
up to 3 months per subject
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the diagnostic criteria for immune thrombocytopenia.
Steroid-resistant/relapsed hospitalized patients, may be male or female, between the ages of 18-80 years.
To show a platelet count < 30×10^9/L, and with bleeding manifestations.
Eastern Cooperative Oncology Group（ECOG）performance status ≤ 2.
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.
Current HIV infection or hepatitis B virus or hepatitis C virus infections. 3.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.
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
Learn more about this trial
A Multicenter Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）
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