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

NCT ID: NCT04481282

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-08
• Study Completion Date: 2021-07-31

Brief Summary

Single-arm, open-label, single center study to assess the efficacy and safety of terbutaline plus danazol in patients with corticosteroid resistant/relapsed ITP.

Detailed Description

Immune thrombocytopenia (ITP) is a severe bleeding disorder. Approximately 2/3 of patients achieve remission from first-line therapies. However, the underlying mechanism of corticosteroid-resistant or relapsed ITP is not well understood; thus, treatment remains a great challenge. β2-AR agonist terbutaline modulates T cell differentiation and effector cell function.

A single center prospective study was performed in non-splenectomized ITP patients who were either resistant to a standard dose of corticosteroids or had relapsed. Patients were assigned to terbutaline plus danazol group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study, in order to assess the efficacy and safety of terbutaline plus danazol in patients with corticosteroid-resistant/relapsed ITP.

Conditions

Immune Thrombocytopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Terbutaline plus Danazol group

Terbutaline 2.5mg tid po plus danazol 200mg bid po for 12weeks

Group Type: EXPERIMENTAL

Terbutaline

Intervention Type: DRUG

2.5mg po tid for 12 weeks

Danazol

Intervention Type: DRUG

200mg po bid for 12 weeks

Interventions

Terbutaline

2.5mg po tid for 12 weeks

Intervention Type: DRUG

Danazol

200mg po bid for 12 weeks

Intervention Type: DRUG

Other Intervention Names

Bricanyl Brethine; Danocrine; Cleregil; Danol

Eligibility Criteria

Inclusion Criteria

• 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;
• Subject has signed and dated written informed consent.
• Fertile patients must use effective contraception during treatment and observational period
• Negative pregnancy test.

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.
• diagnosis with any of the following diseases: chronic hypertension, hyperthyroidism, diabetes, or seizure disorder.

• Minimum Eligible Age: 18 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 Univeristy Institute of Hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaohui Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital, Peking University Insititute of Hematology

Locations

Peking University Insititute of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaohui Zhang, MD

Role: CONTACT

zhangxh100@sina.com

010-88324981

Gaochao Zhang, phD

Role: CONTACT

zhanggaochao0210@163.com

+8618053803755

Facility Contacts

Xiaohui Zhang

Role: primary

zhangxh100@sina.com

Other Identifiers

ITP-PKU010

Identifier Type: -

Identifier Source: org_study_id