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)
An Investigation of rhTPO With Different Frequencies in the Management of ITP
Sponsors
Lead Sponsor
Collaborators
Source
Shandong University
Oversight Info
Has Dmc
Yes
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)
Overall Status
Completed
Start Date
2014-05-01
Completion Date
2015-01-01
Primary Completion Date
2015-01-01
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Early Response |
14 days |
Secondary Outcome
Measure |
Time Frame |
|
Safety |
1 years |
Enrollment
48
Condition
Intervention
Intervention Type
Drug
Intervention Name
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
Arm Group 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
Other Name
tpiao
Recombinant Human Thrombopoietin
Recombinant Human TPO
Eligibility
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 .
Gender
All
Minimum Age
18 Years
Maximum Age
60 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
2014-11-01
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
3
Arm Group
Arm Group Label
rhTPO, 300Units/kg ,daily for 14 consecutive days
Arm Group Type
Experimental
Description
10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days
Arm Group Label
rhTPO, 300Units/kg ,one times every other day for 7 times
Arm Group Type
Experimental
Description
10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,one times every other day for 7 times.
Arm Group Label
rhTPO, 300Units/kg ,daily for 7 consecutive days
Arm Group Type
Experimental
Description
10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 7consecutive days.
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
May 13, 2014
Study First Submitted Qc
May 13, 2014
Study First Posted
May 15, 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 13, 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.