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

Immune Thrombocytopenia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05281068
• Other study ID #: PKU-ITP030
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: April 2022
• Source: Peking University People's Hospital
• Contact: Xiao-Hui Zhang, MD
• Phone: 15010638916
• Email: 1710301242[@]pku.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 iguratimod and danazol versus danazol for the treatment of adults with steroid-resistant/ relapse immune thrombocytopenia (ITP).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 30, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• ITP
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

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-?B (NF-?B), 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.
• Danazol
Oral danazol (200 mg twice daily) for 12 weeks.

Locations

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

Sponsors (7)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained response	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.	6 months
Secondary	Complete remission	The number of participants (responders) with platelet count>=100x10^9/L (CR) and the absence of bleeding.	6 months
Secondary	Partial remission	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.	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	Incidence of treatment-emergent adverse events	Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	6 months