The Combination of Terbutaline and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
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|ClinicalTrials.gov Identifier: NCT04481282|
Recruitment Status : Unknown
Verified July 2020 by Xiao Hui Zhang, Peking University People's Hospital.
Recruitment status was: Recruiting
First Posted : July 22, 2020
Last Update Posted : July 22, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenia||Drug: Terbutaline Drug: Danazol||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Combination of Terbutaline and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia|
|Actual Study Start Date :||July 8, 2020|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Experimental: Terbutaline plus Danazol group
Terbutaline 2.5mg tid po plus danazol 200mg bid po for 12weeks
2.5mg po tid for 12 weeks
Other Name: Bricanyl Brethine
200mg po bid for 12 weeks
- Sustained response [ Time Frame: 6 months ]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. Interim analysis was scheduled at 50% through recruitment.
- complete remission [ Time Frame: 6 months ]The number of participants (responders) with platelet count>=100x10^9/L (CR) and the absence of bleeding.
- partial remission [ Time Frame: 6 months ]The number of participants (responders) with platelet count >=30x10^9/L and at least a 2-fold increase in the baseline count (PR) without the administration of any other platelet increasing therapy.
- time to response [ Time Frame: 6 months ]Time to response was defined as the time from starting treatment to the time to achieve the response. Interim analysis
- duration of response [ Time Frame: 6 months ]Duration of response was measured from the achievement of response to the loss of response.
- incidence of treatment-emergent adverse events [ Time Frame: 6 months ]Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04481282
|Contact: Xiaohui Zhang, MDfirstname.lastname@example.org|
|Contact: Gaochao Zhang, phDemail@example.com|
|Peking University Insititute of Hematology, Peking University People's Hospital||Recruiting|
|Beijing, Beijing, China, 100010|
|Contact: Xiaohui Zhang firstname.lastname@example.org|
|Principal Investigator:||Xiaohui Zhang, MD||Peking University People's Hospital, Peking University Insititute of Hematology|
|Responsible Party:||Xiao Hui Zhang, Vice president of Peking Univeristy Institute of Hematology, Peking University People's Hospital|
|Other Study ID Numbers:||
|First Posted:||July 22, 2020 Key Record Dates|
|Last Update Posted:||July 22, 2020|
|Last Verified:||July 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Blood Coagulation Disorders
Immune System Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists