Atorvastatin in Management of Newly Diagnosed ITP

NCT03692754 | Unknown Phase 2 DMC

• 1 other identifier: Atorvastatin in ITP
• Study Type: interventional
• Target: 30
• 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 atorvastatin for the treatment of adults with immune thrombocytopenia (ITP).

Conditions

Immune Thrombocytopenia; Purpura, Thrombocytopenic

Keywords

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Therapy associated adverse events

  up to 1 year per subject

Study Arms (3)

AT with 10 mg/d

ACTIVE COMPARATOR

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

Drug: Atorvastatin 10mg; Drug: Dexamethasone

AT with 20 mg/d

ACTIVE COMPARATOR

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

Drug: Atorvastatin 20mg; Drug: Dexamethasone

Dexamethasone

EXPERIMENTAL

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

Drug: Dexamethasone

Interventions

Atorvastatin 20mg DRUG

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

Also known as: atorvastatin calcium

AT with 20 mg/d

Atorvastatin 10mg DRUG

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

Also known as: atorvastatin calcium

AT with 10 mg/d

Dexamethasone DRUG

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

AT with 10 mg/d; AT with 20 mg/d; Dexamethasone

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombocytopenic

Interventions

Atorvastatin; Dexamethasone

Condition Hierarchy (Ancestors)

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)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Ming Hou, Dr

  Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Hou, Dr

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: September 29, 2018
• First Posted: October 2, 2018
• Study Start: November 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2023
• Last Updated: September 5, 2021

Record last verified: 2021-08

Locations

CN (1)