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

• Status: Completed
• Trial end date: 2020-01-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Civil de Guadalajara
• Treatments: Acetylcysteine; Atorvastatin; N-monoacetylcystine

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.