search
Back to results

Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine

Primary Purpose

Primary Immune Thrombocytopenia

Status
Completed
Phase
Early Phase 1
Locations
Mexico
Study Type
Interventional
Intervention
Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet
Sponsored by
Hospital Civil de Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Immune Thrombocytopenia focused on measuring Immune thrombocytopenia, Atorvastatin, N-acetylcysteine, Steroids

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients that give their informed consent before the procedures of study
  • Thrombocytopenia before intervention (<100 x10^9 /L)
  • Patients of either biological sex older than 15 years old
  • Patients with previous diagnosis of primary immune thrombocytopenia that not reach complete remission after treatment (steroid based) or that have a relapse
  • If the patient is taking steroid based treatment, the dose need to be stable before intervention.

Exclusion Criteria:

  • Patients with secondary immune thrombocytopenia
  • Pregnant patients
  • Patients with hypersensitivity to study treatments
  • Patients that are taking anticoagulant medication or any drug that have an effect on platelet count
  • Hepatic alteration consisting in serum levels of Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 times above superior laboratory reference limit.
  • Elevation of serum levels of Creatinine or bilirubins above 1.5 mg/dl
  • Any cancer diagnosis
  • Coronary heart disease, congestive heart failure, uncontrolled hypertension or arrhythmias.
  • Previous autoimmune disease diagnosis including: systemic lupus erythematosus, rheumatoid arthritis or systemic sclerosis.

Sites / Locations

  • Hospital Civil de Guadalajara Fray Antonio Alcalde

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Atorvastatin + N-acetylcysteine

Arm Description

Patients included in the study received an oral treatment of Atorvastatin 40 mg daily and N-acetylcysteine 400 mg every 8 hours, for at least 1 month (up to 12 months)

Outcomes

Primary Outcome Measures

Change from Baseline (before intervention) in the Mean Serum Platelet Count at 1, 3, 6 and 12 Months
Blood samples of all participants will be taken previous to the intervention of study and in the 1, 3, 6, adn 12 month, this with the objective of evaluate changes in platelet count after intervention expecting to elevate the platelet count.

Secondary Outcome Measures

Full Information

First Posted
September 20, 2022
Last Updated
September 20, 2022
Sponsor
Hospital Civil de Guadalajara
search

1. Study Identification

Unique Protocol Identification Number
NCT05551624
Brief Title
Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine
Official Title
Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine in Patients With Primary Immune Thrombocytopenia Resistant to Steroid Treatment or in Relapse: An Exploratory Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 4, 2018 (Actual)
Primary Completion Date
December 11, 2019 (Actual)
Study Completion Date
January 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Civil de Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the ability of Atorvastatin and N-acetyl cysteine to elevate the blood (serum) platelet count in patients with Immune Thrombocytopenia as a mean of a new treatment.
Detailed Description
Evaluate the efficacy in the elevation of platelet count of the combination of atorvastatin and N-acetyl cysteine in patients with immune thrombocytopenia resistant to steroid therapy or with relapse after treatment, a prospective, proof of concept clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Thrombocytopenia
Keywords
Immune thrombocytopenia, Atorvastatin, N-acetylcysteine, Steroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Prospective, single group, exploratory (proof of concept) clinical trial to evaluate the effect in serum platelet count of Atorvastatin plus N-acetylcysteine in patients with primary immune thrombocytopenia resistent to steroid therapy or in relapse
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin + N-acetylcysteine
Arm Type
Experimental
Arm Description
Patients included in the study received an oral treatment of Atorvastatin 40 mg daily and N-acetylcysteine 400 mg every 8 hours, for at least 1 month (up to 12 months)
Intervention Type
Drug
Intervention Name(s)
Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet
Intervention Description
Oral tablets administered daily, atorvastatin once a day and N-acetylcysteine every 8 hours
Primary Outcome Measure Information:
Title
Change from Baseline (before intervention) in the Mean Serum Platelet Count at 1, 3, 6 and 12 Months
Description
Blood samples of all participants will be taken previous to the intervention of study and in the 1, 3, 6, adn 12 month, this with the objective of evaluate changes in platelet count after intervention expecting to elevate the platelet count.
Time Frame
Baseline and 1, 3, 6, and 12 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients that give their informed consent before the procedures of study Thrombocytopenia before intervention (<100 x10^9 /L) Patients of either biological sex older than 15 years old Patients with previous diagnosis of primary immune thrombocytopenia that not reach complete remission after treatment (steroid based) or that have a relapse If the patient is taking steroid based treatment, the dose need to be stable before intervention. Exclusion Criteria: Patients with secondary immune thrombocytopenia Pregnant patients Patients with hypersensitivity to study treatments Patients that are taking anticoagulant medication or any drug that have an effect on platelet count Hepatic alteration consisting in serum levels of Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) 3 times above superior laboratory reference limit. Elevation of serum levels of Creatinine or bilirubins above 1.5 mg/dl Any cancer diagnosis Coronary heart disease, congestive heart failure, uncontrolled hypertension or arrhythmias. Previous autoimmune disease diagnosis including: systemic lupus erythematosus, rheumatoid arthritis or systemic sclerosis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrique Cervantes-Perez, MD, MSc
Organizational Affiliation
Hospital Civil de Guadalajara
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Civil de Guadalajara Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Effect in Platelet Count of Atorvastatin and N-acetyl Cysteine

We'll reach out to this number within 24 hrs