An Investigation of rhTPO With Different Frequencies in the Management of ITP

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)

Sponsors

Lead Sponsor: Shandong University

Collaborator: The First Affiliated Hospital of Dalian Medical University
Shandong Provincial Hospital

Source 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)

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 May 2014
Completion Date January 2015
Primary Completion Date January 2015
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: Recombinant Human Thrombopoietin (rhTPO)

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

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
Location Countries

China

Verification Date

November 2014

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

Label: rhTPO, 300Units/kg ,daily for 14 consecutive days

Type: Experimental

Description: 10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days

Label: rhTPO, 300Units/kg ,one times every other day for 7 times

Type: Experimental

Description: 10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,one times every other day for 7 times.

Label: rhTPO, 300Units/kg ,daily for 7 consecutive days

Type: Experimental

Description: 10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 7consecutive days.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov