Study of Females Exposed to Eleclazine

Phase 1

• Conditions: The goal of this study is to follow up with female subjects who received eleclazine in prior clinical trials for ischemic heart disease, ventricular arrhythmia, hypertrophic cardiomyopathy or long QT syndrome.; MedDRA version: 20.0Level: LLTClassification code 10055218Term: Ischemic heart diseaseSystem Organ Class: 10007541 - Cardiac disorders; MedDRA version: 20.0Level: PTClassification code 10020871Term: Hypertrophic cardiomyopathySystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.1Level: PTClassification code 10024803Term: Long QT syndromeSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2019-003958-86-FR
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-02-08
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 177

Inclusion Criteria

Subjects must meet all the following inclusion criteria to be eligible for participation in this study:
1) Females who received at least one dose of eleclazine in a prior clinical trial
2) Signed informed consent form (ICF), by the subject or a legally authorized representative, obtained before any study-related activities are undertaken

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 152
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

There are no exclusion criteria for this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this study is to follow up with females exposed to eleclazine in prior clinical trials.;Secondary Objective: There are no secondary objectives for this study.;Primary end point(s): The endpoints of interest include the number of females enrolled and the number of females with signs or symptoms potentially consistent with uterine cancer after eleclazine exposure.;Timepoint(s) of evaluation of this end point: End of study

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): There are no secondary endpoints for this study.;Timepoint(s) of evaluation of this end point: There are no secondary endpoints for this study.