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

Primary Purpose

Immune Thrombocytopenia, Pregnancy

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

rhTPO

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring recombinant human thrombopoietin, immune thrombocytopenia, pregnancy

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Subject is between 18-50 years old.
After 12 weeks gestation.
Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
Patients who have no response or relapsed after Corticosteroid or IVIG.
Patients developed refractoriness to platelet transfusion.
To show a platelet count < 30×10^9/L, and with bleeding manifestations.
Willing and able to sign written informed consent.

Exclusion Criteria:

Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
Current HIV infection or hepatitis B virus or hepatitis C virus infections.
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)
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.
Patients who are deemed unsuitable for the study by the investigator.

Sites / Locations

Shandong University Qilu hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rhTPO

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety

Adverse events in patients and infants.

Full Information

NCT ID

NCT02270801

First Posted

October 17, 2014

Last Updated

April 18, 2016

Sponsor

Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT02270801

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

January 2017 (Anticipated)

Study Completion Date

April 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune Thrombocytopenia, Pregnancy

Keywords

recombinant human thrombopoietin, immune thrombocytopenia, pregnancy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

rhTPO

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

rhTPO

Other Intervention Name(s)

TPIAO, S20050048/49 (SFDA, China)

Intervention Description

Primary Outcome Measure Information:

Title

Early Response

Description

Time Frame

one month after delivery

Secondary Outcome Measure Information:

Title

Safety

Description

Adverse events in patients and infants.

Time Frame

six months after delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is between 18-50 years old. After 12 weeks gestation. Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia. Patients who have no response or relapsed after Corticosteroid or IVIG. Patients developed refractoriness to platelet transfusion. To show a platelet count < 30×10^9/L, and with bleeding manifestations. Willing and able to sign written informed consent. Exclusion Criteria: Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit. Current HIV infection or hepatitis B virus or hepatitis C virus infections. 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) 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. Patients who are deemed unsuitable for the study by the investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Hou, MD PhD

Phone

86-531-82169114

Ext

9879

houming@medmail.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Hou, MD PhD

Organizational Affiliation

Shandong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shandong University Qilu hospital

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Hou, MD PhD

Phone

+86-531-82169114

Ext

9879

houming@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Ming Hou

12. IPD Sharing Statement

Learn more about this trial

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

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