Overview

The Combination of ATRA and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

Status:
Completed
Trial end date:
2020-06-30
Target enrollment:
0
Participant gender:
All
Summary
Randomized, open-label, multicenter study to compare the efficacy and safety of ATRA plus high-dose dexamethasone compared to high-dose dexamethasone monotherapy for the first-line 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 Aerospace General Hospital
Beijing Hospital
Beijing Tongren Hospital
Qilu Hospital of Shandong University
The Sixth Medical Center of PLA General Hospital
Treatments:
BB 1101
Dexamethasone
Dexamethasone acetate
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 6 months before the screening visit;

2. Received first-line and second-line ITP-specific treatments (eg, steriods,
cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;

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

4. Active infection;

5. Maligancy;

6. 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);

7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate
pregnancy during the study period; a history of clinically significant adverse
reactions to previous corticosteroid therapy

8. 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;

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