Status:
UNKNOWN
The Combination of Tacrolimus and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Beijing Hospital
Beijing Friendship Hospital
Conditions:
ITP
Immune Thrombocytopenia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Randomized, open-label, multicenter study to compare the efficacy and safety of Combination of High-dose Dexamethasone and Tacrolimus versus High-dose Dexamethasone for the first-line treatment of adu...
Detailed Description
The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 100 adults with ITP in China. Patients were randomized to tacrolimuis plus high-dose dexamethasone and h...
Eligibility Criteria
Inclusion
- Confirmed newly-diagnosed, treatment-naive ITP;
- Platelet counts \<30×109/L ;
- Platelet counts \< 50×109/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
- Willing and able to sign written informed consent.
Exclusion
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
- Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
- Current HIV infection or hepatitis B virus or hepatitis C virus infections;
- Active infection;
- Maligancy;
- 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);
- 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
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04747080
Start Date
March 1 2021
End Date
July 1 2023
Last Update
February 10 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking University People's Hospital
Beijing, China, 100000