The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia

NCT ID: NCT05494307

Last Updated: 2022-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2024-02-28

Brief Summary

A randomized, open-label, multicenter study to compare the efficacy and safety of terbutaline plus danazol compared to danazol monotherapy for the second-line treatment of adults with corticosteroid-resistant or relapsed primary immune thrombocytopenia (ITP).

Detailed Description

The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 228 adults with ITP in China. Patients were randomized to terbutaline plus danazol compared to danazol monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Terbutaline plus danazol

Terbutaline: A dose of 2.5 mg three times daily for 16 weeks Danazol: A dose of 200 mg twice daily for 16 weeks

Group Type: EXPERIMENTAL

Terbutaline

Intervention Type: DRUG

Orally terbutaline at a dose of 2.5 mg three times daily for 16 weeks

Danazol

Intervention Type: DRUG

Orally danazol at a dose of 200 mg twice daily for 16 weeks

Danazol monotherapy

Danazol: A dose of 200 mg twice daily for 16 weeks

Group Type: ACTIVE_COMPARATOR

Danazol

Intervention Type: DRUG

Orally danazol at a dose of 200 mg twice daily for 16 weeks

Interventions

Terbutaline

Orally terbutaline at a dose of 2.5 mg three times daily for 16 weeks

Intervention Type: DRUG

Danazol

Orally danazol at a dose of 200 mg twice daily for 16 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Not achieving a sustained response to therapy with full-dose corticosteroids for a duration of at least 4 weeks or relapsed during the process of corticosteroid tapering or discontinuation;

2. Platelet counts <30×10^9/L or platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above);

3. Willing and able to sign written informed consent.

Exclusion Criteria

1. Pregnant or lactating women;

2. Secondary ITP (have a known diagnosis of connective tissue diseases, malignancy, active infection, HIV infections or hepatitis B virus or hepatitis C virus infections);

3. Received drugs affecting the platelet counts within 6 months before the screening visit (e.g., chemotherapy, anticoagulants, etc);

4. Severe medical condition (lung, heart, hepatic or renal disorder);

5. Patients who are deemed unsuitable for the study by the investigator.

6. Patients who had hypertension, diabetes mellitus, hyperthyroidism or coronary heart disease.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiao Hui Zhang

Vice President of Peking University Institute of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiao-Hui Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Central Contacts

Ye-Jun Wu, MD

Role: CONTACT

wyejun1999@pku.edu.cn

13522338836

Other Identifiers

PKU-ITP039

Identifier Type: -

Identifier Source: org_study_id