Atorvastatin in Management of Newly Diagnosed ITP

August 30, 2021 updated by: Ming Hou, Shandong University

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 3

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

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital, Shandong University
        • Principal Investigator:
          • Ming Hou

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

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Received chemotherapy or anticoagulants or other drugs affecting theplatelet counts within 3 months before the screening visit.
  2. Received steroids or other effective therapy for immune thrombocytopenia.
  3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  4. Severe medical condition (lung, hepatic or renal disorder) other than ITP.
  5. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
  6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
  7. 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.
  8. 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
Active Comparator: AT with 10 mg/d
The patients will be given receive atorvastatin in 10 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.
Drug: Atorvastatin 10mg
Atorvastatin will be given in 10 mg po qn for 1 month
Other Names:
  • atorvastatin calcium
Drug: Dexamethasone
Dexamethasone will be given in 40mg po qd for 4 days
Active Comparator: AT with 20 mg/d
The patients will be given atorvastatin in 20 mg/d for 1 month plus dexamethasone 40mg/d for 4 days.
Drug: Dexamethasone
Dexamethasone will be given in 40mg po qd for 4 days
Drug: Atorvastatin 20mg
Atorvastatin will be given in 20 mg po qn for 1 month
Other Names:
  • atorvastatin calcium
Experimental: Dexamethasone
The patients will be given dexamethasone 40mg/d for 4 days.
Drug: Dexamethasone
Dexamethasone will be given in 40mg po qd for 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of platelet response
Time Frame: up to 1 year per subject
Platelet count will be observed at 1 month, 3 months, 6 months and 12 months after atorvastatin therapy
up to 1 year per subject

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapy associated adverse events
Time Frame: up to 1 year per subject
The number and frequency of therapy associated adverse events
up to 1 year per subject

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Investigators

  • Principal Investigator: Ming Hou, Dr, Shandong University

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)

November 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

September 29, 2018

First Submitted That Met QC Criteria

September 29, 2018

First Posted (Actual)

October 2, 2018

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Atorvastatin in ITP

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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