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

Peking University

Status and phase: Unknown; Phase 2

Conditions: ITP; Immune Thrombocytopenia

Treatments: Drug: Danazol; Drug: Iguratimod

Study type: Interventional

Funder types: Other

Identifiers

NCT05281068

PKU-ITP030

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Iguratimod and Danazol

Experimental group

Description:

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

Treatment:

Drug: Danazol

Drug: Iguratimod

Danazol

Active Comparator group

Description:

Danazol is given at 200mg bid for 12 weeks.

Treatment:

Drug: Danazol