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

NCT ID: NCT02139501

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-01-31

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)

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

Group Type: EXPERIMENTAL

Recombinant Human Thrombopoietin (rhTPO)

Intervention Type: DRUG

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

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

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

Group Type: EXPERIMENTAL

Recombinant Human Thrombopoietin (rhTPO)

Intervention Type: DRUG

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

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

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

Group Type: EXPERIMENTAL

Recombinant Human Thrombopoietin (rhTPO)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

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 .

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Dalian Medical University

OTHER

Sponsor Role: collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Ming Hou

Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Hou, Dr

Role: PRINCIPAL_INVESTIGATOR

Shandong University

Locations

Qilu Hospital, Shandong University

Jinan, Shandong, China

Countries

China

Other Identifiers

ITP-Thrombopoietin

Identifier Type: -

Identifier Source: org_study_id