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

Primary Purpose

Immune Thrombocytopenia

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Terbutaline
Danazol
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients >18 years old with corticosteroid-resistant or relapsed ITP who had either a platelet count of <30×10^9/L or a platelet count of <50×10^9/L and clinically significant bleeding.

  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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Terbutaline plus danazol

    Danazol monotherapy

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Overall response
    Achieving a platelet count ≥ 30 × 10^9/L confirmed on at least two separate occasions (at least 7 days apart), at least a doubling of the baseline platelet count without any other ITP-specific treatment and the absence of bleeding.

    Secondary Outcome Measures

    Sustained response
    maintenance of a platelet count > 30 × 10^9/L, an absence of bleeding, and no requirement for any other ITP-specific treatment for 6 consecutive months after achievement of OR
    Complete response
    a platelet count ≥ 100 × 10^9/L measured on two occasions at least 7 days apart and the absence of bleeding
    Remission
    a durable platelet count > 30 × 109/L without bleeding up to 12 months after randomization
    Time to response
    the time from starting treatment to the time a response was achieved.
    Duration of response
    time from OR until loss of response or until the last follow-up visit
    Rescue therapy
    any new medical intervention taken to increase the platelet count or prevent bleeding events or an increase in the dose of concomitant treatments
    Associated factors of treatment failure, OR, SR and remission
    Factors that are associated with treatment failure, OR, SR and remission
    Number of patients with bleeding
    Number of patients with bleeding complication (WHO bleeding score)
    Number of patients with side effects
    Number of patients with Medication adverse events.
    Relapse
    Loss of OR
    Relapse-free survival
    the time interval between achievement of OR and relapse or the end of the follow-up

    Full Information

    First Posted
    August 6, 2022
    Last Updated
    August 6, 2022
    Sponsor
    Peking University People's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05494307
    Brief Title
    The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia
    Official Title
    A Multicenter Randomized Trial of Second Line Treatment for Corticosteroid-Resistant or Relapsed Immune Thrombocytopenia: Combined Terbutaline and Danazol Versus Danazol Monotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2022 (Anticipated)
    Primary Completion Date
    September 1, 2023 (Anticipated)
    Study Completion Date
    February 28, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Peking University People's Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Immune Thrombocytopenia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    228 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Terbutaline plus danazol
    Arm Type
    Experimental
    Arm Description
    Terbutaline: A dose of 2.5 mg three times daily for 16 weeks Danazol: A dose of 200 mg twice daily for 16 weeks
    Arm Title
    Danazol monotherapy
    Arm Type
    Active Comparator
    Arm Description
    Danazol: A dose of 200 mg twice daily for 16 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Terbutaline
    Intervention Description
    Orally terbutaline at a dose of 2.5 mg three times daily for 16 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Danazol
    Intervention Description
    Orally danazol at a dose of 200 mg twice daily for 16 weeks
    Primary Outcome Measure Information:
    Title
    Overall response
    Description
    Achieving a platelet count ≥ 30 × 10^9/L confirmed on at least two separate occasions (at least 7 days apart), at least a doubling of the baseline platelet count without any other ITP-specific treatment and the absence of bleeding.
    Time Frame
    From date of randomization until 1 years or the end of follow-up
    Secondary Outcome Measure Information:
    Title
    Sustained response
    Description
    maintenance of a platelet count > 30 × 10^9/L, an absence of bleeding, and no requirement for any other ITP-specific treatment for 6 consecutive months after achievement of OR
    Time Frame
    From date of randomization until 1 years or the end of follow-up
    Title
    Complete response
    Description
    a platelet count ≥ 100 × 10^9/L measured on two occasions at least 7 days apart and the absence of bleeding
    Time Frame
    From date of randomization until 1 years or the end of follow-up
    Title
    Remission
    Description
    a durable platelet count > 30 × 109/L without bleeding up to 12 months after randomization
    Time Frame
    at 12-month follow-up
    Title
    Time to response
    Description
    the time from starting treatment to the time a response was achieved.
    Time Frame
    From date of randomization until 1 years or the end of follow-up
    Title
    Duration of response
    Description
    time from OR until loss of response or until the last follow-up visit
    Time Frame
    From date of randomization until 1 years or the end of follow-up
    Title
    Rescue therapy
    Description
    any new medical intervention taken to increase the platelet count or prevent bleeding events or an increase in the dose of concomitant treatments
    Time Frame
    From date of randomization until 1 years or the end of follow-up
    Title
    Associated factors of treatment failure, OR, SR and remission
    Description
    Factors that are associated with treatment failure, OR, SR and remission
    Time Frame
    From date of randomization until 1 years or the end of follow-up
    Title
    Number of patients with bleeding
    Description
    Number of patients with bleeding complication (WHO bleeding score)
    Time Frame
    From date of randomization until 1 years or the end of follow-up
    Title
    Number of patients with side effects
    Description
    Number of patients with Medication adverse events.
    Time Frame
    From date of randomization until 1 years or the end of follow-up
    Title
    Relapse
    Description
    Loss of OR
    Time Frame
    From date of randomization until 1 years or the end of follow-up
    Title
    Relapse-free survival
    Description
    the time interval between achievement of OR and relapse or the end of the follow-up
    Time Frame
    From date of randomization until 1 years or the end of follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients >18 years old with corticosteroid-resistant or relapsed ITP who had either a platelet count of <30×10^9/L or a platelet count of <50×10^9/L and clinically significant bleeding. 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; Platelet counts <30×10^9/L or platelet counts < 50×10^9/L and significant bleeding symptoms (WHO bleeding scale 2 or above); Willing and able to sign written informed consent. Exclusion Criteria: Pregnant or lactating women; Secondary ITP (have a known diagnosis of connective tissue diseases, malignancy, active infection, HIV infections or hepatitis B virus or hepatitis C virus infections); Received drugs affecting the platelet counts within 6 months before the screening visit (e.g., chemotherapy, anticoagulants, etc); Severe medical condition (lung, heart, hepatic or renal disorder); Patients who are deemed unsuitable for the study by the investigator. Patients who had hypertension, diabetes mellitus, hyperthyroidism or coronary heart disease.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ye-Jun Wu, MD
    Phone
    13522338836
    Email
    wyejun1999@pku.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiao-Hui Zhang, MD
    Organizational Affiliation
    Peking University People's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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