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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
Sponsor:
Information provided by (Responsible Party):
Ming Hou, Shandong University

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.

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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


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




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



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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:

  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.

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
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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