Efficacy and Safety of Iguratimod in the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia

Immune Thrombocytopenia Clinical Trial

Official title:

Efficacy and Safety of Iguratimod in the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia: a Phase 2, Open-label, Single-arm Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05302024
• Other study ID #: I-ITP 001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 22, 2022
• Est. completion date: December 12, 2023

Study information

• Verified date: March 2022
• Source: Peking University People's Hospital
• Contact: Xiao-Hui Zhang, MD
• Phone: 86-10-88324577
• Email: zhangxh[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A phase 2, open-label, single-arm study to evaluate the efficacy and safety of iguratimod for the treatment of adults with steroid-resistant/relapse immune thrombocytopenia (ITP)

Description:

The investigators are undertaking an open-label, single-arm study of 100 adults with steroid-resistant/ relapse ITP in China. Patients were received Iguratimod treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 12, 2023
• Est. primary completion date: December 12, 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 30×10^9/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;

• 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
• 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.

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	Durable 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.	6 months
Secondary	Initial response	Platelet count = 30 x 10^9/L and at least doubling baseline at 1 month	1 month
Secondary	Remission	109/ Platelet count >100x 10^9/L at 12 mon	12 months
Secondary	Time to response	Time to response was defined as the time from starting treatment to the time to achieve the response	12 months
Secondary	Bleeding	Major bleeding: (1) WHO grade 3 or 4 bleeding, (2) Buchanan severe grade, (3) Bolton-Maggs and Moon "major bleeding," (4) IBLS grade 2 or higher, or (5) life-threatening or intracerebral hemorrhage bleeding	12 months
Secondary	Adverse events	Adverse events	12 months