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

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ClinicalTrials.gov Identifier: NCT05281068
Recruitment Status : Recruiting
First Posted : March 15, 2022
Last Update Posted : May 2, 2022
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Xiao Hui Zhang, Peking University People's Hospital

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
ITP Immune Thrombocytopenia Drug: Iguratimod Drug: Danazol 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 1, 2021
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : December 30, 2023


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 Name: 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.




Primary Outcome Measures :
  1. Sustained response [ Time Frame: 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 [ Time Frame: 6 months ]
    The number of participants (responders) with platelet count>=100x10^9/L (CR) and the absence of bleeding.

  2. Partial remission [ Time Frame: 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 [ 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. Incidence of treatment-emergent adverse events [ Time Frame: 6 months ]
    Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.



Information from the National Library of Medicine

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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) 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.

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): NCT05281068


Contacts
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Contact: Xiao-Hui Zhang, MD 15010638916 1710301242@pku.edu.cn
Contact: Zhuo-Yu An, MD 15010638916 anzhuoyu@pku.edu.cn

Locations
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China
Zhuo-Yu An Recruiting
Beijing, China, 100044
Contact: Zhuo-Yu An    15010638916    anzhuoyu@pku.edu.cn   
Peking University Insititute of Hematology, Peking University People's Hospital Recruiting
Beijing, China
Contact: Xiao-hui Zhang, Professor       zhangxh100@sina.com   
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
Investigators
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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
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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: March 15, 2022    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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