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Thrombocytopenia in Gestational Period

Primary Purpose

Immune Thrombocytopenia, Pregnancy

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Dexamethasone

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring pregnancy, Immune Thrombocytopenia, dexamethasone

Eligibility Criteria

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

Inclusion Criteria:

Subject is between 20-50 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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dexamethasone

Arm Description

dexamethasone 40mg/d for 4 days

Outcomes

Primary Outcome Measures

Response rate (CR+R)

Secondary Outcome Measures

Platelet count

Adverse events

live birth rate

Full Information

NCT ID

NCT02751593

First Posted

April 17, 2016

Last Updated

April 21, 2016

Sponsor

Peking University People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02751593

Brief Title

Thrombocytopenia in Gestational Period

Official Title

Thrombocytopenia in Gestational Period

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking University People's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The project was undertaking by Peking University People's Hospital and other well-known hospitals in China. Aims at evaluating efficacy and safety of dexamethasone in management of ITP in pregnancy.

Detailed Description

The investigators are undertaking a multicenter, open-labeled, pilot study of 50 ITP patients in pregnancy from Peking University People's Hospital 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 dexamethasone intravenously at a dose of 40mg every day for four days. 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

pregnancy, Immune Thrombocytopenia, dexamethasone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

dexamethasone

Arm Type

Experimental

Arm Description

dexamethasone 40mg/d for 4 days

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

dexamethasone 40mg/d for 4 days

Primary Outcome Measure Information:

Title

Response rate (CR+R)

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Platelet count

Time Frame

2 years

Title

Adverse events

Time Frame

2 years

Title

live birth rate

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is between 20-50 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiao-hui Zhang, Dr

Organizational Affiliation

Peking University People's Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Thrombocytopenia in Gestational Period

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