A Multicenter Study on Recombinant Human Thrombopoietin in Management of ITP in Pregnancy

NCT ID: NCT02391272

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-06-30

Brief Summary

The project was undertaking by Qilu Hospital of Shandong University and other well-known hospitals in China. Aims at evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.

Detailed Description

The investigators are undertaking a multicenter, open-labeled, pilot study of 30 ITP patients in pregnancy from Qilu Hospital of Shandong University and other well-known hospitals in China. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given rhTPO intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.

Conditions

Immune Thrombocytopenia; Pregnancy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rhTPO

rhTPO will be given intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10\^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week.

Group Type: EXPERIMENTAL

rhTPO

Intervention Type: DRUG

Interventions

rhTPO

Intervention Type: DRUG

Other Intervention Names

TPIAO

Eligibility Criteria

Inclusion Criteria

1. Subject is between 18-50 years old.

2. After 12 weeks gestation.

3. Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.

4. Patients who have no response or relapsed after Corticosteroid or IVIG.

5. Patients developed refractoriness to platelet transfusion.

6. To show a platelet count < 30×10^9/L, and with bleeding manifestations.

7. 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. Current HIV infection or hepatitis B virus or hepatitis C virus infections.

4. 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)

5. 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.

6. Patients who are deemed unsuitable for the study by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: collaborator

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role: collaborator

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: collaborator

Southern Medical University, China

OTHER

Sponsor Role: collaborator

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Ming Hou

Professor and Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ming Hou, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Shandong University Qilu Hospital

Locations

Qilu Hospital, Shandong University

Jinan, Shandong, China

Countries

China

References

Kong Z, Qin P, Xiao S, Zhou H, Li H, Yang R, Liu X, Luo J, Li Z, Ji G, Cui Z, Bai Y, Wu Y, Shao L, Peng J, Ma J, Hou M. A novel recombinant human thrombopoietin therapy for the management of immune thrombocytopenia in pregnancy. Blood. 2017 Aug 31;130(9):1097-1103. doi: 10.1182/blood-2017-01-761262. Epub 2017 Jun 19.

Reference Type: DERIVED

PMID: 28630121 (View on PubMed)

Other Identifiers

ITP-pregnancy-rhTPO-Multi

Identifier Type: -

Identifier Source: org_study_id