Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）
A Multicenter Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Cyclosporin A Versus Cyclosporin A in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia （ITP）
Sponsors
Source
Shandong University
Oversight Info
Has Dmc
Yes
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.
Overall Status
Withdrawn
Start Date
2014-07-01
Completion Date
N/A
Primary Completion Date
2015-07-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Evaluation of platelet response (Complete Response) |
The time frame is up to 3 months per subject |
|
Evaluation of platelet response (Response) |
The time frame is up to 3 months per subject |
|
Evaluation of platelet response (No Response) |
The time frame is up to 3 months per subject |
|
Evaluation of platelet response (relapses) |
The time frame is up to 3 months per subject |
Secondary Outcome
Measure |
Time Frame |
|
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 |
up to 3 months per subject |
Condition
Intervention
Intervention Type
Drug
Intervention Name
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.
Arm Group Label
combination treatment group
single treatment group
Intervention Type
Drug
Intervention Name
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
Arm Group Label
combination treatment group
Eligibility
Criteria
Inclusion Criteria:
1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Steroid-resistant/relapsed 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. 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.
Gender
All
Minimum Age
18 Years
Maximum Age
80 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Ming Hou, Dr. |
Principal Investigator |
Shandong University |
Location
Facility |
|
Qilu Hospital, Shandong University Jinan Shandong 250012 China |
Location Countries
Country
China
Verification Date
2014-07-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Shandong University
Investigator Full Name
Ming Hou
Investigator Title
Professor and Director
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Cyclosporine
Cyclosporins
Arm Group
Arm Group Label
combination treatment group
Arm Group Type
Experimental
Description
60 enrolled patients are randomly picked up to take cyclosporin A in combination with rhTPO at the indicated dose.
Arm Group Label
single treatment group
Arm Group Type
Active Comparator
Description
60 enrolled patients are randomly picked up to take cyclosporin A at the indicated dose.
Firstreceived Results Date
N/A
Why Stopped
No eligible patient was enrolled.
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Study First Submitted
July 27, 2014
Study First Submitted Qc
July 27, 2014
Study First Posted
July 29, 2014
Last Update Submitted
April 18, 2016
Last Update Submitted Qc
April 18, 2016
Last Update Posted
April 20, 2016
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.