We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05471050
Recruitment Status : Recruiting
First Posted : July 22, 2022
Last Update Posted : July 22, 2022
Sponsor:
Information provided by (Responsible Party):
Xiao Hui Zhang, Peking University People's Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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).

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: TAC Drug: Danazol Phase 2

Detailed 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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Combination of Tacrolimus and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia: A Randomized, Controlled, Open-label Trial
Actual Study Start Date : March 2, 2022
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: tacrolimus and Danazol
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.
 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.

Drug: Danazol
Danazol is given at 200mg bid for 12 weeks.
Active Comparator: Danazol
Danazol is given at 200mg bid for 12 weeks.
 Drug: Danazol
Danazol is given at 200mg bid for 12 weeks.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Sustained response [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Complete response [ Time Frame: 6 months ]
    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.

  2. Response [ Time Frame: 6 months ]
    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.

  3. Time to response [ Time Frame: 6 months ]
    Time to response was defined as the time from starting treatment to the time to achieve the response.

  4. Duration of response [ Time Frame: 6 months ]
    Duration of response was measured from the achievement of response to the loss of response.

  5. Adverse events [ Time Frame: 6 months ]
    Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05471050


Contacts
Layout table for location contacts
Contact: Xiao-Hui Zhang, MD +8613522338836 zhangxh@bjmu.edu.cn
Contact: Xuan Cai, MD +8618811729606 2206385254@qq.com

Locations
Layout table for location information
China, Beijing
Peking University Insititute of Hematology, Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100010
Contact: Xiao-hui Zhang, MD    +8613522338836    zhangxh@bjmu.edu.cn   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
Layout table for investigator information
Principal Investigator: Xiao-Hui Zhang, MD Peking University People's Hospital, Peking University Insititute of Hematology
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Xiao Hui Zhang, Vice president of Peking Univeristy Institute of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT05471050    
Other Study ID Numbers: PKU-ITP036
First Posted: July 22, 2022    Key Record Dates
Last Update Posted: July 22, 2022
Last Verified: July 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiao Hui Zhang, Peking University People's Hospital:
Immune Thrombocytopenia
tacrolimus
danazol
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Pathologic Processes
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
 Autoimmune Diseases
Immune System Diseases
Hemorrhage
Skin Manifestations
Danazol
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs