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A Multicenter Randomized Study of Vitamin D Combined With HD-DXM Versus HD-DXM for the Treatment of ITP

Primary Purpose

Immune Thrombocytopenia

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Rocaltrol

Dexamethasone

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:

Corresponding to the diagnostic criteria for immune thrombocytopenia
Newly diagnosed ITP patients
To show a platelet count <30 * 10^9/L, and with bleeding manifestations
Willing and able to sign written informed consent

Exclusion Criteria:

Suffered from diseases associated with hypercalcemia.
Vitamin D intoxication
Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit;
Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit; 3.Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study;
Current HIV infection;
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;
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.

Sites / Locations

Qilu hospital, Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Rocaltrol Combining HD-DXM

HD-DXM

Arm Description

Rocaltrol 0.25 μg once per day, 1 month; HD-DXM (orally at 40 mg daily for 4d )

HD-DXM (orally at 40 mg daily for 4d )

Outcomes

Primary Outcome Measures

Sustained response to ITP treatments

Percentage of patients maintaining PLT count over 30*10^9 without bleeding

Secondary Outcome Measures

Evaluation of platelet response

Complete response (CR)： A platelet count ≥ 100 * 10^9/L measured on two occasions > 7 days apart and the absence of bleeding. Response (R)： A platelet count ≥ 30 * 10^9/L and a greater than two fold increase in platelet count from baseline measured on two occasions > 7 days apart and the absence of bleeding. No response (NR)： A platelet count < 30 * 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.

Full Information

NCT ID

NCT04094805

First Posted

September 17, 2019

Last Updated

September 7, 2020

Sponsor

Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT04094805

Brief Title

A Multicenter Randomized Study of Vitamin D Combined With HD-DXM Versus HD-DXM for the Treatment of ITP

Official Title

A Multicenter Randomized Open-label Clinical Trial of Vitamin D Combined With HD-DXM Versus HD-DXM for the Treatment of ITP

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 1, 2020 (Anticipated)

Primary Completion Date

March 1, 2021 (Anticipated)

Study Completion Date

October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

Detailed Description

The investigators anticipate to undertaking a prospective, multicenter, randomised controlled trial of 60 ITP adult patients. One part of the participants are randomly selected to receive vitamin D (given Rocaltrol orally at a dose of 0.25 μg per day for 1 month), combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, two-cycles with an interval of 10 days); the others are selected to receive high-dose of dexamethasone treatment plus placebo. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Serum calcium and creatinine are monitored. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of vitamin D combining with high-dose dexamethasone therapy for the treatment of adults with ITP.

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 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rocaltrol Combining HD-DXM

Arm Type

Active Comparator

Arm Description

Rocaltrol 0.25 μg once per day, 1 month; HD-DXM (orally at 40 mg daily for 4d )

Arm Title

HD-DXM

Arm Type

Active Comparator

Arm Description

HD-DXM (orally at 40 mg daily for 4d )

Intervention Type

Drug

Intervention Name(s)

Rocaltrol

Other Intervention Name(s)

Calcitriol Soft Capsules

Intervention Description

Rocaltrol 0.25 μg daily for 1 month; HD-DXM (orally at 40 mg daily for 4d )

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

HD-DXM (orally at 40 mg daily for 4d )

Primary Outcome Measure Information:

Title

Sustained response to ITP treatments

Description

Percentage of patients maintaining PLT count over 30*10^9 without bleeding

Time Frame

3 months after treatment started

Secondary Outcome Measure Information:

Title

Evaluation of platelet response

Description

Time Frame

3 months after treatment started

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Corresponding to the diagnostic criteria for immune thrombocytopenia Newly diagnosed ITP patients To show a platelet count <30 * 10^9/L, and with bleeding manifestations Willing and able to sign written informed consent Exclusion Criteria: Suffered from diseases associated with hypercalcemia. Vitamin D intoxication Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit; Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit; 3.Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study; Current HIV infection; 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; 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming Hou, MD,PhD

Phone

+86-531-82169114

Ext

9879

houming@medmail.com.cn

Facility Information:

Facility Name

Qilu hospital, Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Multicenter Randomized Study of Vitamin D Combined With HD-DXM Versus HD-DXM for the Treatment of ITP

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