The Combination of Tacrolimus and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

Official title:

The Combination of Tacrolimus and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia: A Randomized, Controlled, Open-label Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05471050
• Other study ID #: PKU-ITP036
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: July 2022
• Source: Peking University People's Hospital
• Contact: Xiao-Hui Zhang, MD
• Phone: +8613522338836
• Email: zhangxh[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized, open-label, multicenter study to compare the efficacy and safety of combination of tacrolimus and danazol versus danazol for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP).

Description:

The investigators are undertaking a randomized controlled trial of 120 adults with steroid-resistant/relapse ITP in China. Patients were randomized to tacrolimus plus danazol and danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Primary immune thrombocytopenia (ITP);

• 18 years older;

• Platelet count of less than 30×10^9/L at enrollment;

• Patients who did not achieve a sustained response to treatment with full-dose corticosteroids for a minimum duration of 4 weeks or who relapsed during steroid-tapering or after its discontinuation;

• Patients who were receiving other maintenance regimens, primarily corticosteroids, ciclosporin, or mycophenolate mofetil, were also eligible if the dose of treatment had been stable in the past month and the dose was expected to be stable after enrolment and remained unchanged at least for the first 4 weeks of study until initial response was assessed, unless severe adverse events were suspected.

Exclusion Criteria:

• Secondary ITP (e.g., patients with HIV, HBV, HCV, Helicobacter pylori infection or SLE);

• Congestive heart failure, severe arrhythmia;

• Nursing or pregnant women;

• ALT or AST levels = 3× the upper limit of the normal threshold;

• Creatinine or serum bilirubin levels = 1.5× the upper limit;

• Active or previous malignancy ;

• Patients who had received danazol treatment or did not respond to danazol;

• Patients unable to have routine blood tests because of reasons such as insufficient time.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• TAC
Tacrolimus is given at a dose of 0.03mg/kg·d, and the dose is adjusted to maintain the trough concentration of tacrolimus at approximately 3-5 ng/mL for 12 weeks.
• Danazol
Danazol is given at 200mg bid for 12 weeks.

Locations

Country	Name	City	State
China	Peking University Insititute of Hematology, Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained response	Sustained response was defines as the maintenance of platelet count = 30 x 10^9/L, and at least 2-fold increase of the baseline count, and the absence of bleeding, and no need for rescue medication at the 6-month follow-up.	6 months
Secondary	Complete response	Complete response was defines as the maintenance of platelet count = 100 x 10^9/L, and at least 2-fold increase of the baseline count, and the absence of bleeding, and no need for rescue medication.	6 months
Secondary	Response	Response was defines as the maintenance of platelet count = 30 x 10^9/L, and at least 2-fold increase of the baseline count, and the absence of bleeding, and no need for rescue medication.	6 months
Secondary	Time to response	Time to response was defined as the time from starting treatment to the time to achieve the response.	6 months
Secondary	Duration of response	Duration of response was measured from the achievement of response to the loss of response.	6 months
Secondary	Adverse events	Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	6 months