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

Primary Immune Thrombocytopenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05551624
• Other study ID #: 178/19
• Status: Completed
• Phase: Early Phase 1
• Start date: July 4, 2018
• Est. completion date: January 23, 2020

Study information

• Verified date: September 2022
• Source: Hospital Civil de Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 23, 2020
• Est. primary completion date: December 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Primary Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital Civil de Guadalajara Fray Antonio Alcalde	Guadalajara	Jalisco

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Civil de Guadalajara

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 1, 3, 6, and 12 months after intervention