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

Pregnancy Clinical Trial

Official title:

A Multicenter Open-labeled Pilot Study on Recombinant Human Thrombopoietin in Management of Immune Thrombocytopenia in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02391272
• Other study ID #: ITP-pregnancy-rhTPO-Multi
• Status: Completed
• Phase: Phase 3
• Start date: March 2015
• Est. completion date: June 2016

Study information

• Verified date: March 2016
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Pregnancy
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• rhTPO

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
Shandong University	Institute of Hematology & Blood Diseases Hospital, Southern Medical University, China, The Affiliated Hospital of Qingdao University, The Second Hospital of Hebei Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early response 1- Response rate (CR+R)	Response rate (CR+R) at the 7th day. CR is defined as platelet count = 100×10^9/L, and R is defined as platelet count of >30×10^9/L with at least a doubling of the baseline value.	7th day
Primary	Early response 2- Response rate (CR+R)	Response rate (CR+R) at the 14th day.	14th day
Primary	Long-time response 1 (Platelet count)	Platelet count at 10th week.	10th week
Primary	Long-time response 2 (Platelet count)	Platelet count at 40 weeks' gestation.	40 weeks' gestation
Primary	Long-time response 3 (Platelet count)	Platelet count one month after delivery.	one month after delivery
Primary	Safety (Adverse events)	Adverse events in patients and infants.	6 months after delivery