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High-dose Dexamethasone Plus Hetrombopag vs High-dose Dexamethasone Alone as Frontline Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial

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ClinicalTrials.gov Identifier: NCT05943691
Recruitment Status : Recruiting
First Posted : July 13, 2023
Last Update Posted : September 26, 2023
Sponsor:
Information provided by (Responsible Party):
Ming Hou, Shandong University

Brief Summary:
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of Hetrombopag plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).

Condition or disease Intervention/treatment Phase
ITP - Immune Thrombocytopenia Drug: hetrombopag 5mg po qd Drug: High-dose Dexamethasone Phase 2

Detailed Description:
The investigators anticipate to undertaking a parallel group, randomised controlled trial of 100 ITP patients. One part of the participants are randomly selected to receive hetrombopag with starting dose 5mg po qd for 8 weeks(increase daily dose to a maximum of 7.5 mg/day if platelet count<50000 per μL following at least 2 weeks of treatment) combining with dexamethasone (given at a dose of 40 mg qd for 4 consecutive days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to dexamethasone may receive another cycle of high-dose dexamethasone therapy within 2 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. The purpose of this study is to report the efficacy and safety of Hetrombopag combining with high-dose dexamethasone therapy for the treatment of newly diagnosed ITP.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-dose Dexamethasone Plus Hetrombopag Versus High-dose Dexamethasone Alone as Frontline Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia (ITP):A Prospective Multicenter Randomized Trial
Estimated Study Start Date : September 15, 2023
Estimated Primary Completion Date : July 10, 2024
Estimated Study Completion Date : December 10, 2024


Arm Intervention/treatment
Experimental: Hetrombopag plus High-dose Dexamethasone
Hetrombopag 5mg po qd; HD-DEX 40mg qd for 4 days
Drug: hetrombopag 5mg po qd
hetrombopag 5mg po qd for 8 weeks, combining with dexamethasone 40 mg qd for 4 days

Drug: High-dose Dexamethasone
dexamethasone 40 mg qd for 4 days

Active Comparator: High-dose Dexamethasone
HD-DEX 40mg qd for 4 days
Drug: High-dose Dexamethasone
dexamethasone 40 mg qd for 4 days




Primary Outcome Measures :
  1. 26 week sustained overall response to ITP treatments [ Time Frame: 26-week after treatment started ]

    Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding.

    Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding.

    No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.



Secondary Outcome Measures :
  1. 28-day initial complete response to ITP treatment [ Time Frame: 28 days after treatment started] ]

    Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding.

    Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding.

    No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.


  2. 28-day initial overall response to ITP treatment [ Time Frame: 28 days after treatment started ]

    Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding.

    Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding.

    No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.


  3. 8-week complete response to ITP treatment [ Time Frame: 8 weeks after treatment started ]

    Complete response was defined as a platelet count of 100 000 per μL or higher and an absence of bleeding.

    Partial response was defined as a platelet count of 30000 per μL or higher,and at least a doubling of the baseline platelet count and an absence of bleeding.

    No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.


  4. 8-week overall response to ITP treatment [ Time Frame: 8 weeks after treatment started ]
    No response was defined as a platelet count of less than 30000 per μL, or less than two-times increase from baseline platelet count, or bleeding.

  5. time to response [ Time Frame: an average of 6 months ]
    the time from treatment initiation to achieve a complete response or a partial response

  6. duration of response [ Time Frame: through study completion, an average of one year ]
    the time from achievement of a complete response or a partial response to the loss of response

  7. therapy associated adverse events [ Time Frame: through study completion, an average of one year ]


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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:

  • Older than 18 years
  • Meet the diagnostic criteria for newly diagnosed immune thrombocytopenia (diagnosed within 3 month);
  • platelet count <30*10^9/L, or < 50*10^9/L with bleeding manifestations, both;
  • Willing and able to sign written informed consent

Exclusion Criteria:

  • secondary thrombocytopenia or graded MF≥2 myelofbrosis based on the European Consensus Scale
  • Previous history of treatment for ITP, except Platelet transfusion, ITP-directed Prednisone therapy no more than 2 weeks or TPO therapy no more than 1 week and stopped ≥1 week before randomization
  • No response to TPO-RA or rhTPO
  • HIV, hepatitis C or B virus infection
  • pregnancy or lactation;
  • arterial or venous thromboembolism within the 6 months before screening
  • total bilirubinalanine, aminotransferase or aspartate transaminase>3×upper limit of normal (ULN), serum creatinine>1.5×ULN
  • congestive heart failure (New York Heart Association [NYHA] class III/IV);
  • neoplastic disease within the past 5 years;
  • liver cirrhosis
  • people who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.

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): NCT05943691


Contacts
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Contact: Yan Shi 8682169896 shiyansjj@163.com

Locations
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China, Shandong
Shengli Oilfield Central Hospital Recruiting
Dongying, Shandong, China
Contact: Liang Wang, MD    18654620224      
Sponsors and Collaborators
Shandong University
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Responsible Party: Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier: NCT05943691    
Other Study ID Numbers: ITP-Hetrombopag plus HD-DEX
First Posted: July 13, 2023    Key Record Dates
Last Update Posted: September 26, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ming Hou, Shandong University:
Hetrombopag, Dexamethasone
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Cytopenia
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents