Atorvastatin in Management of Newly Diagnosed ITP | NCT03692754

Studies
Atorvastatin in Management of Newly Diagnosed ITP

NCT03692754

Sponsor

Shandong University

Status

Unknown status

Last Update Posted

Sep 5, 2021Actual

Enrollment

30Estimated

Phase

Phase 2Phase 3

Conditions

Immune Thrombocytopenia
Purpura, Thrombocytopenic

Interventions

Atorvastatin 20mg
Atorvastatin 10mg
Dexamethasone

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2021Estimated

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Sep 29, 2018

First Submission Date that Met QC Criteria

Sep 29, 2018

First Posted Date

Oct 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2021

Last Update Posted Date

Sep 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Atorvastatin 20mg	Drug	Atorvastatin will be given in 20 mg po qn for 1 month	AT with 20 mg/d

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Ming Hou, Dr	Contact	+86-531-82169114	9879	houming@medmail.com.cn

Name	Affiliation	Role
Ming Hou, Dr	Shandong University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Qilu hospital, Shandong University		Jinan	Shandong	250012	China

Condition Browse Module

MeSH Terms

ID	Term
D016553	Purpura, Thrombocytopenic, Idiopathic
D011696	Purpura, Thrombocytopenic

Ancestor Terms

ID	Term
D011693	Purpura
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069059	Atorvastatin
D003907	Dexamethasone

Ancestor Terms

ID	Term
D011758	Pyrroles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided