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

Immune Thrombocytopenia Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139501
• Other study ID #: ITP-Thrombopoietin
• Status: Completed
• Phase: Phase 3
• First received: May 13, 2014
• Last updated: April 18, 2016
• Start date: May 2014
• Est. completion date: January 2015

Study information

• Verified date: November 2014
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 .

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• Recombinant Human Thrombopoietin (rhTPO)
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

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (3)

Lead Sponsor	Collaborator
Shandong University	Shandong Provincial Hospital, The First Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days	No
Secondary	Safety	The type and frequency of therapy associated adverse events	1 years	Yes