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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
Sponsor:
Information provided by (Responsible Party):
Xiao Hui Zhang, Peking University People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenia Drug: Terbutaline Drug: Danazol Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Terbutaline plus Danazol group
Terbutaline 2.5mg tid po plus danazol 200mg bid po for 12weeks
 Drug: Terbutaline
2.5mg po tid for 12 weeks
Other Name: Bricanyl Brethine

Drug: Danazol
200mg po bid for 12 weeks
Other Names:
  • Danocrine
  • Cleregil
  • Danol


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. complete remission [ Time Frame: 6 months ]
    The number of participants (responders) with platelet count>=100x10^9/L (CR) and the absence of bleeding.

  2. 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.

  3. 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

  4. duration of response [ Time Frame: 6 months ]
    Duration of response was measured from the achievement of response to the loss of response.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Xiaohui Zhang, MD 010-88324981 zhangxh100@sina.com
Contact: Gaochao Zhang, phD +8618053803755 zhanggaochao0210@163.com

Locations
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China, Beijing
Peking University Insititute of Hematology, Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100010
Contact: Xiaohui Zhang       zhangxh100@sina.com   
Sponsors and Collaborators
Peking University People's Hospital
Investigators
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Principal Investigator: Xiaohui Zhang, MD Peking University People's Hospital, Peking University Insititute of Hematology
More Information
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Responsible Party: Xiao Hui Zhang, Vice president of Peking Univeristy Institute of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04481282    
Other Study ID Numbers: ITP-PKU010
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: July 22, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Pathologic Processes
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Skin Manifestations
Terbutaline
 Danazol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents