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

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

Sponsors

Lead Sponsor: Peking University People's Hospital

Source Peking University People's Hospital
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.

Overall Status Recruiting
Start Date July 8, 2020
Completion Date July 31, 2021
Primary Completion Date March 31, 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Sustained response 6 months
Secondary Outcome
Measure Time Frame
complete remission 6 months
partial remission 6 months
time to response 6 months
duration of response 6 months
incidence of treatment-emergent adverse events 6 months
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: Terbutaline

Description: 2.5mg po tid for 12 weeks

Arm Group Label: Terbutaline plus Danazol group

Other Name: Bricanyl Brethine

Intervention Type: Drug

Intervention Name: Danazol

Description: 200mg po bid for 12 weeks

Arm Group Label: Terbutaline plus Danazol group

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Xiaohui Zhang, MD Principal Investigator Peking University People's Hospital, Peking University Insititute of Hematology
Overall Contact

Last Name: Xiaohui Zhang, MD

Phone: 010-88324981

Email: [email protected]

Location
Facility: Status: Contact: Peking University Insititute of Hematology, Peking University People's Hospital Xiaohui Zhang [email protected]
Location Countries

China

Verification Date

July 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Peking University People's Hospital

Investigator Full Name: Xiao Hui Zhang

Investigator Title: Vice president of Peking Univeristy Institute of Hematology

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Terbutaline plus Danazol group

Type: Experimental

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

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov