A Study of ATRA in the Treatment of ITP

• Status: Not yet recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

An open-label, multicenter study to compare the efficacy and safety of ATRA for the treatment of adults with primary immune thrombocytopenia (ITP)

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

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborators: Beijing Hospital; Qilu Hospital of Shandong University; The Sixth Medical Center of PLA General Hospital
• Treatments: Tretinoin

Criteria

Inclusion Criteria:

1. Confirmed newly-diagnosed, treatment-naive ITP;

2. Platelet counts <30×109/L ;

3. Platelet counts < 50×109/L and significant bleeding symptoms (WHO bleeding scale 2 or above);

4. 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 first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit;

3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.

4. Current HIV infection or hepatitis B virus or hepatitis C virus infections;

5. 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);

6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period;

7. 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;

8. Patients who are deemed unsuitable for the study by the investigator.