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

NCT04747080 | Unknown Phase 2 DMC

• 1 other identifier: ITP-PKU022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

ITP; Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Sustained（Durable） response

  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.

  6 months

Secondary Outcomes (9)

• Complete response (CR)

  Day 14

• Response (R)

  Day 14

• Time to response

  6 months

• Duration of response (DOR)

  6 months

• Loss of response

  6 months

Study Arms (2)

TAC and HD-DXM

EXPERIMENTAL

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; Drug: Tacrolimus

HD-DXM

ACTIVE COMPARATOR

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

Interventions

Dexamethasone DRUG

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).

Also known as: HD-DXM, High-dose Dexamethasone

HD-DXM; TAC and HD-DXM

Tacrolimus DRUG

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.

Also known as: TAC

TAC and HD-DXM

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Beijing Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• China-Japan Friendship Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Shanxi Bethune Hospital: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, 100000, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Dexamethasone; Tacrolimus

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Peking University Institute of Hematology

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 10, 2021
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: July 1, 2023
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

CN (1)