Atorvastatin in Management of Newly Diagnosed ITP

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03692754
• Other study ID #: Atorvastatin in ITP
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: November 1, 2021
• Est. completion date: December 1, 2023

Study information

• Verified date: August 2021
• Source: Shandong University
• Contact: Ming Hou, Dr
• Phone: +86-531-82169114
• Email: houming[@]medmail.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Drug:
• Atorvastatin 20mg
Atorvastatin will be given in 20 mg po qn for 1 month
• Atorvastatin 10mg
Atorvastatin will be given in 10 mg po qn for 1 month
• Dexamethasone
Dexamethasone will be given in 40mg po qd for 4 days

Locations

Country	Name	City	State
China	Qilu hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of platelet response	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	Therapy associated adverse events	The number and frequency of therapy associated adverse events	up to 1 year per subject