Thrombocytopenia in Gestational Period

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University People's Hospital
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

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.