Clinical trial NCT05551624: 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
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Primary Immune Thrombocytopenia
Keywords: Immune thrombocytopenia
Atorvastatin
N-acetylcysteine
Steroids
Lead sponsor: Hospital Civil de Guadalajara
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 15
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 relapse
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline (before intervention) in the Mean Serum Platelet Count at 1, 3, 6 and 12 Months
timeFrame: Baseline and 1, 3, 6, and 12 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Hospital Civil de Guadalajara Fray Antonio Alcalde
state: Jalisco
Study officials:
affiliation: Hospital Civil de Guadalajara
name: Enrique Cervantes-Perez, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: