Atorvastatin in Management of Newly Diagnosed ITP

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ClinicalTrials.gov Identifier: NCT03692754

Recruitment Status : Not yet recruiting

First Posted : October 2, 2018

Last Update Posted : September 5, 2021

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Sponsor:

Information provided by (Responsible Party):

Ming Hou, Shandong University

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).

Condition or disease	Intervention/treatment	Phase
Immune Thrombocytopenia Purpura, Thrombocytopenic	Drug: Atorvastatin 20mg Drug: Atorvastatin 10mg Drug: Dexamethasone	Phase 2 Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Single-center Prospective Randomized Study of Atorvastatin in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
Estimated Study Start Date :	November 1, 2021
Estimated Primary Completion Date :	December 1, 2021
Estimated Study Completion Date :	December 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Immune thrombocytopenia Thrombotic thrombocytopenic purpura

Drug Information available for: Dexamethasone Atorvastatin Atorvastatin calcium

Genetic and Rare Diseases Information Center resources: Idiopathic Thrombocytopenic Purpura Immune Thrombocytopenia

U.S. FDA Resources

Arms and Interventions

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 Name: 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: Atorvastatin 20mg Atorvastatin will be given in 20 mg po qn for 1 month Other Name: atorvastatin calcium Drug: Dexamethasone Dexamethasone will be given in 40mg po qd for 4 days
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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

Therapy associated adverse events [ Time Frame: up to 1 year per subject ]
The number and frequency of therapy associated adverse events

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692754

Contacts

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Contact: Ming Hou, Dr	+86-531-82169114 ext 9879	houming@medmail.com.cn

Locations

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China, Shandong
Qilu hospital, Shandong University
Jinan, Shandong, China, 250012
Contact: Ming Hou houming@medmail.com.cn
Principal Investigator: Ming Hou

Sponsors and Collaborators

Shandong University

Investigators

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Principal Investigator:	Ming Hou, Dr	Shandong University

More Information

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Responsible Party:	Ming Hou, Professor and Director, Shandong University
ClinicalTrials.gov Identifier:	NCT03692754
Other Study ID Numbers:	Atorvastatin in ITP
First Posted:	October 2, 2018 Key Record Dates
Last Update Posted:	September 5, 2021
Last Verified:	August 2021

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Ming Hou, Shandong University:


Immune Thrombocytopenia

Additional relevant MeSH terms:

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Thrombocytopenia Immune System Diseases Purpura Purpura, Thrombocytopenic, Idiopathic Purpura, Thrombocytopenic Blood Platelet Disorders Hematologic Diseases Blood Coagulation Disorders Hemorrhage Pathologic Processes Skin Manifestations Thrombotic Microangiopathies Hemorrhagic Disorders Autoimmune Diseases Calcium, Dietary	Dexamethasone Atorvastatin Calcium Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Calcium-Regulating Hormones and Agents

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