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

• Sponsor: Hospital Civil de Guadalajara (Other)
• Overall Status: Completed
• CT.gov ID: NCT05551624
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Actual Duration (Months): 18.7
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Immune Thrombocytopenia	Drug: Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet	Early Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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 relapseProspective, 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)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 4, 2018
• Actual Primary Completion Date: Dec 11, 2019
• Actual Study Completion Date: Jan 23, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Atorvastatin + N-acetylcysteine 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)	Drug: Atorvastatin 40 Mg Oral Tablet + N-acetylcysteine 400 mg Oral tablet; Oral tablets administered daily, atorvastatin once a day and N-acetylcysteine every 8 hours

Outcome Measures

Primary Outcome Measures

1. Change from Baseline (before intervention) in the Mean Serum Platelet Count at 1, 3, 6 and 12 Months [Baseline and 1, 3, 6, and 12 months after intervention]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara	Jalisco	Mexico	44280

Sponsors and Collaborators

• Hospital Civil de Guadalajara

Investigators

• Principal Investigator: Enrique Cervantes-Perez, MD, MSc, Hospital Civil de Guadalajara

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Enrique Cervantes-Perez, Attending Internal Medicine Physician and Professor to the Department of Internal Medicine, Hospital Civil de Guadalajara "Fray Antonio Alcalde"., Hospital Civil de Guadalajara
• ClinicalTrials.gov Identifier: NCT05551624
• Other Study ID Numbers: 178/19
• First Posted: Sep 22, 2022
• Last Update Posted: Sep 22, 2022
• Last Verified: Sep 1, 2022

• 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
• Keywords provided by Enrique Cervantes-Perez, Attending Internal Medicine Physician and Professor to the Department of Internal Medicine, Hospital Civil de Guadalajara "Fray Antonio Alcalde"., Hospital Civil de Guadalajara: Immune thrombocytopenia; Atorvastatin; N-acetylcysteine; Steroids
• Additional relevant MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic; Acetylcysteine; Atorvastatin; N-monoacetylcystine

Study Results

No Results Posted as of Sep 22, 2022