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

Sponsor
Peking University People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05281068
Collaborator
Beijing Hospital (Other), China-Japan Friendship Hospital (Other), Beijing Friendship Hospital (Other), The First Affiliated Hospital of Zhengzhou University (Other), First Affiliated Hospital of Chongqing Medical University (Other), Shanxi Bethune hospital, Shanxi, China (Other)
120
2
2
27.9
60
2.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 100 adults with steroid-resistant/ relapse ITP in China. Patients were randomized to Iguratimod 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

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Combination of Iguratimod and Danazol Versus Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia: A Randomized, Controlled, Multicenter, Open-label Trial
Actual Study Start Date :
Sep 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Iguratimod and Danazol

Iguratimod is given at a dose of 25 mg bid. Danazol is given at 200mg bid for 12 weeks.

Drug: Iguratimod
Oral iguratimod (25 mg twice daily) for 12 weeks. Iguratimod is a new drug for the treatment of rheumatoid arthritis (RA) and osteoarthritis (OA), which was filed for marketing in Japan in 2003. It can significantly reduce the inflammatory response, not only selectively inhibit COX-2, but also inhibit the production of inflammatory cytokines, tumor necrosis factor, lymphocytes and immunoglobulins, and has an autoimmunomodulatory effect; it has a rapid onset of action, better efficacy and fewer adverse effects than existing drugs, and is effective in patients for whom other drugs are ineffective. It has been reported in the literature that in vitro iguratimod can inhibit the activity of nuclear factor-κB (NF-κB), which in turn inhibits the production of inflammatory cytokines (interleukin-1, interleukin-6, interleukin-8, tumor necrosis factor alpha). Iguratimod also interacts directly with mouse and human B cells in vitro to inhibit the production of immunoglobulins.
Other Names:
  • Iremod
  • Drug: Danazol
    Oral danazol (200 mg twice daily) for 12 weeks.

    Active Comparator: Danazol

    Danazol is given at 200mg bid for 12 weeks.

    Drug: Danazol
    Oral danazol (200 mg twice daily) for 12 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Sustained response [6 months]

      The maintenance of platelet count ≥ 30 x 10^9/L, at least 2-fold increase of the baseline count, the absence of bleeding, and no need for rescue medication at the 6-month follow-up. Interim analysis was scheduled at 50% through recruitment.

    Secondary Outcome Measures

    1. Complete remission [6 months]

      The number of participants (responders) with platelet count>=100x10^9/L (CR) and the absence of bleeding.

    2. Partial remission [6 months]

      The number of participants (responders) with platelet count >=30x10^9/L and at least a 2-fold increase in the baseline count (PR) without the administration of any other platelet increasing therapy.

    3. Time to response [6 months]

      Time to response was defined as the time from starting treatment to the time to achieve the response.

    4. Duration of response [6 months]

      Duration of response was measured from the achievement of response to the loss of response.

    5. Incidence of treatment-emergent adverse events [6 months]

      Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Primary immune thrombocytopenia (ITP) confirmed by excluding other supervened causes of thrombocytopenia;

    • Platelet count of less than 30×109/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;

    • 18 years older;

    Exclusion Criteria:
    • Secondary immune thrombocytopenia (e.g., patients with HIV, HCV, Helicobacter pylori infection or patients with systemic lupus erythematosus)

    • Congestive heart failure

    • Severe arrhythmia

    • Nursing or pregnant women

    • Aspartate aminotransferase and alanine transaminase levels ≥ 3× the upper limit of the normal threshold criteria

    • Creatinine or serum bilirubin levels each 1•5 times or more than the normal range

    • Active or previous malignancy

    • Unable to do blood routine test for the sake of time, distance, economic issues or other reasons.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhuo-Yu An Beijing China 100044
    2 Peking University Insititute of Hematology, Peking University People's Hospital Beijing China

    Sponsors and Collaborators

    • Peking University People's Hospital
    • Beijing Hospital
    • China-Japan Friendship Hospital
    • Beijing Friendship Hospital
    • The First Affiliated Hospital of Zhengzhou University
    • First Affiliated Hospital of Chongqing Medical University
    • Shanxi Bethune hospital, Shanxi, China

    Investigators

    • Principal Investigator: Xiao-Hui Zhang, MD, Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiao Hui Zhang, Vice president of Peking University Institute of Hematology, Peking University People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05281068
    Other Study ID Numbers:
    • PKU-ITP030
    First Posted:
    Mar 15, 2022
    Last Update Posted:
    May 2, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 2, 2022