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

NCT04094805 | Unknown Phase 4

• 1 other identifier: ITP-Vitamin D+HD-DXM
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Sustained response to ITP treatments

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

  3 months after treatment started

Secondary Outcomes (1)

• Evaluation of platelet response

  3 months after treatment started

Study Arms (2)

Rocaltrol Combining HD-DXM

ACTIVE COMPARATOR

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

Drug: Rocaltrol; Drug: Dexamethasone

HD-DXM

ACTIVE COMPARATOR

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

Drug: Rocaltrol

Interventions

Rocaltrol DRUG

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

Also known as: Calcitriol Soft Capsules

HD-DXM; Rocaltrol Combining HD-DXM

Dexamethasone DRUG

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

Rocaltrol Combining HD-DXM

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Calcitriol; Dexamethasone

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)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids, Fluorinated

Central Study Contacts

Ming Hou, MD,PhD

CONTACT

+86-531-82169114; houming@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: October 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: October 1, 2021
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)