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The Combination of Tacrolimus and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia

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ClinicalTrials.gov Identifier: NCT04747080
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Collaborators:
Beijing Hospital
Beijing Friendship Hospital
China-Japan Friendship Hospital
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Chongqing Medical University
Shanxi Bethune Hospital
Information provided by (Responsible Party):
Xiao Hui Zhang, Peking University People's Hospital

Study Description
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Brief Summary:
Randomized, open-label, multicenter study to compare the efficacy and safety of Combination of High-dose Dexamethasone and Tacrolimus versus High-dose Dexamethasone for the first-line treatment of adults with primary immune thrombocytopenia (ITP).

Condition or disease Intervention/treatment Phase
ITP Immune Thrombocytopenia Drug: Dexamethasone Drug: Tacrolimus Phase 2

Detailed Description:
The investigators are undertaking a parallel group, multicenter, randomized controlled trial of 100 adults with ITP in China. Patients were randomized to tacrolimuis plus high-dose dexamethasone and high-dose dexamethasone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Combination of High-dose Dexamethasone and Tacrolimus Versus High-dose Dexamethasone as the First-Line Treatment of Newly-diagnosed Immune Thrombocytopenia: A Randomized, Controlled, Multicenter, Open-label Trial
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : July 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: TAC and HD-DXM

Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone is repeated in the case of lack of response by day 14).

Tacrolimus is given at a dose of 0.03mg/kg·d, and the dose is adjusted to maintain the trough concentration of tacrolimus at approximately 3-5 ng/mL for 12 weeks.

 Drug: Dexamethasone
Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone is repeated in the case of lack of response by day 14).
Other Names:
  • HD-DXM
  • High-dose Dexamethasone

Drug: Tacrolimus
Tacrolimus is given at a dose of 0.03mg/kg·d, and the dose is adjusted to maintain the trough concentration of tacrolimus at approximately 3-5 ng/mL for 12 weeks.
Other Name: TAC
Active Comparator: HD-DXM
Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone is repeated in the case of lack of response by day 14) .
 Drug: Dexamethasone
Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone is repeated in the case of lack of response by day 14).
Other Names:
  • HD-DXM
  • High-dose Dexamethasone


Outcome Measures
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Primary Outcome Measures :
  1. Sustained（Durable） 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.


Secondary Outcome Measures :
  1. Complete response (CR) [ Time Frame: Day 14 ]
    Complete response (CR) was defined as platelet count more than 100,000 per cubic millimeter and absence of bleeding.

  2. Response (R) [ Time Frame: Day 14 ]
    Response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding.

  3. Time to response [ Time Frame: 6 months ]
    The time from starting treatment to time of achievement of CR or R.

  4. Duration of response (DOR) [ Time Frame: 6 months ]
    Duration of response at 6-month follow up.

  5. Loss of response [ Time Frame: 6 months ]
    Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R)

  6. Number of participants with clinically significant bleeding as assessed using the world health organization (WHO) bleeding scale [ Time Frame: From the start of study treatment (Day 1) up to the end of week 24. ]
    The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.

  7. Immune Thrombocytopenia Patient Assessment Questionnaire (ITP-PAQ) [ Time Frame: Time Frame: From the start of study treatment (Day 1) up to the end of week 24. ]
    In all participants ,use ITP-PAQ to assess the Health Related Quality of Life(HRQoL) before and after treatment.

  8. Functional Assessment of Chronic Illness Therapy fatigue subscale (FACIT-F) [ Time Frame: Time Frame: From the start of study treatment (Day 1) up to the end of week 24. ]
    In all participants ,use FACIT-F to assess the Health Related Quality of Life(HRQoL) before and after treatment.

  9. Number of Participants with side effects of the drugs [ Time Frame: Time Frame: From the start of study treatment (Day 1) up to the end of week 24. ]
    Side effects of the drugs included fever, headache, serum disease, infection, hypotension, rashes, infection liver injury, hypokalaemia, etc.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Confirmed newly-diagnosed, treatment-naive ITP;
  2. Platelet counts <30×109/L ;
  3. Platelet counts < 50×109/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
  4. Willing and able to sign written informed consent.

Exclusion Criteria:

  1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
  2. Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
  3. Current HIV infection or hepatitis B virus or hepatitis C virus infections;
  4. Active infection;
  5. Maligancy;
  6. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia);
  7. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy
  8. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
  9. Patients who are deemed unsuitable for the study by the investigator.
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): NCT04747080


Locations
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China
Peking University People's Hospital Recruiting
Beijing, China, 100000
Contact: Zhuo-Yu Zhang, doctor    +8615010638916    zhangxh100@sina.com   
Contact: Zhuo Yu An, doctor    +8615010638916    anzhuoyu@pku.edu.cn   
Sponsors and Collaborators
Peking University People's Hospital
Beijing Hospital
Beijing Friendship Hospital
China-Japan Friendship Hospital
The First Affiliated Hospital of Zhengzhou University
First Affiliated Hospital of Chongqing Medical University
Shanxi Bethune Hospital
More Information
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Responsible Party: Xiao Hui Zhang, Vice President of Peking University Institute of Hematology, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT04747080    
Other Study ID Numbers: ITP-PKU022
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Dexamethasone
 Dexamethasone acetate
BB 1101
Tacrolimus
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
Protease Inhibitors