- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04747080
The Combination of Tacrolimus and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia
February 5, 2021 updated by: Xiao Hui Zhang, Peking University People's Hospital
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
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).
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China, 100000
- Recruiting
- Peking University People's Hospital
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Contact:
- Zhuo-Yu Zhang, doctor
- Phone Number: +8615010638916
- Email: zhangxh100@sina.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Confirmed newly-diagnosed, treatment-naive ITP;
- Platelet counts <30×109/L ;
- Platelet counts < 50×109/L and significant bleeding symptoms (WHO bleeding scale 2 or above);
- Willing and able to sign written informed consent.
Exclusion Criteria:
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
- Received first-line and second-line ITP-specific treatments (eg, steriods, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) ;
- Current HIV infection or hepatitis B virus or hepatitis C virus infections;
- Active infection;
- Maligancy;
- 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);
- 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
- 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;
- Patients who are deemed unsuitable for the study by the investigator.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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. |
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:
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 Names:
|
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) .
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Day 14
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Response (R)
Time Frame: Day 14
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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.
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Day 14
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Time to response
Time Frame: 6 months
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The time from starting treatment to time of achievement of CR or R.
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6 months
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Duration of response (DOR)
Time Frame: 6 months
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Duration of response at 6-month follow up.
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6 months
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Loss of response
Time Frame: 6 months
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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)
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6 months
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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.
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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.
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From the start of study treatment (Day 1) up to the end of week 24.
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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.
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In all participants ,use ITP-PAQ to assess the Health Related Quality of Life(HRQoL) before and after treatment.
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Time Frame: From the start of study treatment (Day 1) up to the end of week 24.
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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.
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In all participants ,use FACIT-F to assess the Health Related Quality of Life(HRQoL) before and after treatment.
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Time Frame: From the start of study treatment (Day 1) up to the end of week 24.
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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.
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Side effects of the drugs included fever, headache, serum disease, infection, hypotension, rashes, infection liver injury, hypokalaemia, etc.
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Time Frame: From the start of study treatment (Day 1) up to the end of week 24.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2021
Primary Completion (Anticipated)
March 1, 2023
Study Completion (Anticipated)
July 1, 2023
Study Registration Dates
First Submitted
February 5, 2021
First Submitted That Met QC Criteria
February 5, 2021
First Posted (Actual)
February 10, 2021
Study Record Updates
Last Update Posted (Actual)
February 10, 2021
Last Update Submitted That Met QC Criteria
February 5, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Immune System Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Hemorrhage
- Hemorrhagic Disorders
- Blood Coagulation Disorders
- Skin Manifestations
- Blood Platelet Disorders
- Thrombotic Microangiopathies
- Purpura, Thrombocytopenic
- Purpura
- Purpura, Thrombocytopenic, Idiopathic
- Thrombocytopenia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Protease Inhibitors
- Calcineurin Inhibitors
- Dexamethasone
- Dexamethasone acetate
- BB 1101
- Tacrolimus
Other Study ID Numbers
- ITP-PKU022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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