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Atorvastatin in Management of Newly Diagnosed ITP

Primary Purpose

Immune Thrombocytopenia, Purpura, Thrombocytopenic

Status

Not yet recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Atorvastatin 20mg

Atorvastatin 10mg

Dexamethasone

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia focused on measuring Immune Thrombocytopenia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meet the diagnostic criteria for immune thrombocytopenia.
within 3 months from diagnosis,untreated patients, may be male orfemale, between the ages of 18 ~ 80 years.
To show a platelet count > 30×10^9/L and without bleeding manifestations.

Exclusion Criteria:

Received chemotherapy or anticoagulants or other drugs affecting theplatelet counts within 3 months before the screening visit.
Received steroids or other effective therapy for immune thrombocytopenia.
Current HIV infection or hepatitis B virus or hepatitis C virus infections.
Severe medical condition (lung, hepatic or renal disorder) other than 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 3

Arm Type

Active Comparator

Experimental

Arm Label

AT with 10 mg/d

AT with 20 mg/d

Dexamethasone

Arm Description

The patients will be given receive atorvastatin in 10 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.

The patients will be given atorvastatin in 20 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.

The patients will be given dexamethasone 40mg/d for 4 days.

Outcomes

Primary Outcome Measures

Evaluation of platelet response

Platelet count will be observed at 1 month, 3 months, 6 months and 12 months after atorvastatin therapy

Secondary Outcome Measures

Therapy associated adverse events

The number and frequency of therapy associated adverse events

Full Information

NCT ID

NCT03692754

First Posted

September 29, 2018

Last Updated

August 30, 2021

Sponsor

Shandong University

1. Study Identification

Unique Protocol Identification Number

NCT03692754

Brief Title

Atorvastatin in Management of Newly Diagnosed ITP

Official Title

A Single-center Prospective Randomized Study of Atorvastatin in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

November 1, 2021 (Anticipated)

Primary Completion Date

December 1, 2021 (Anticipated)

Study Completion Date

December 1, 2023 (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

Data Monitoring Committee

Yes

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 atorvastatin for the treatment of adults with immune thrombocytopenia (ITP).

Detailed Description

The investigators anticipate to undertaking a parallel group, single-centre, randomised controlled trial of 30 ITP adult patients, which have no indications of glucocorticoid therapy (platelets count > 30*10^9/L )from Qilu Hospital of Shandong University in China.15 of the participants are randomly selected to receive atorvastatin in 20 mg/d combining with 10 mg/d for 6 months. Platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of atorvastatin 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, Purpura, Thrombocytopenic

Keywords

Immune Thrombocytopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AT with 10 mg/d

Arm Type

Active Comparator

Arm Description

The patients will be given receive atorvastatin in 10 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.

Arm Title

AT with 20 mg/d

Arm Type

Active Comparator

Arm Description

The patients will be given atorvastatin in 20 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.

Arm Title

Dexamethasone

Arm Type

Experimental

Arm Description

The patients will be given dexamethasone 40mg/d for 4 days.

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 20mg

Other Intervention Name(s)

atorvastatin calcium

Intervention Description

Atorvastatin will be given in 20 mg po qn for 1 month

Intervention Type

Drug

Intervention Name(s)

Atorvastatin 10mg

Other Intervention Name(s)

atorvastatin calcium

Intervention Description

Atorvastatin will be given in 10 mg po qn for 1 month

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Dexamethasone will be given in 40mg po qd for 4 days

Primary Outcome Measure Information:

Title

Evaluation of platelet response

Description

Platelet count will be observed at 1 month, 3 months, 6 months and 12 months after atorvastatin therapy

Time Frame

up to 1 year per subject

Secondary Outcome Measure Information:

Title

Therapy associated adverse events

Description

The number and frequency of therapy associated adverse events

Time Frame

up to 1 year per subject

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: Meet the diagnostic criteria for immune thrombocytopenia. within 3 months from diagnosis,untreated patients, may be male orfemale, between the ages of 18 ~ 80 years. To show a platelet count > 30×10^9/L and without bleeding manifestations. Exclusion Criteria: Received chemotherapy or anticoagulants or other drugs affecting theplatelet counts within 3 months before the screening visit. Received steroids or other effective therapy for immune thrombocytopenia. Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than 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, Dr

Phone

+86-531-82169114

Ext

9879

houming@medmail.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Hou, Dr

Organizational Affiliation

Shandong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Qilu hospital, Shandong University

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250012

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming Hou

houming@medmail.com.cn

First Name & Middle Initial & Last Name & Degree

Ming Hou

12. IPD Sharing Statement

Learn more about this trial

Atorvastatin in Management of Newly Diagnosed ITP

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