Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy

Pregnancy Clinical Trial

Official title:

Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP)in Pregnancy: a Single-center Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02270801
• Other study ID #: rhTPO-ITP-Pregnancy
• Status: Recruiting
• Phase: Phase 3
• First received: October 17, 2014
• Last updated: April 18, 2016
• Start date: October 2014
• Est. completion date: April 2017

Study information

• Verified date: March 2016
• Source: Shandong University
• Contact: Ming Hou, MD PhD
• Phone: 86-531-82169114
• Email: houming[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: People's Republic of China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

This clinical trial is undertaking by Qilu Hospital of Shandong University, aims at evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.

Description:

The investigators are undertaking a single-center, non-randomized, non-controlled trial of 30 ITP patients in pregnancy from Qilu Hospital of Shandong University. 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: Recruiting
• Enrollment: 30
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Shandong University Qilu hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong 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, the 10th week from the initial injection of rhTPO, ante partum and one month after delivery. CR is defined as platelet count = 100×109/L, and R is defined as platelet count of >30×109/L with at least a doubling of the baseline value.	one month after delivery	No
Secondary	Safety	Adverse events in patients and infants.	six months after delivery	Yes