Study of Females Exposed to Eleclazine

Study of Females Exposed to Eleclazine - NA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003958-86-IT

Enrollment

177

Registered

2022-06-30

Start date

2023-05-02

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 20.0 Level: LLT Classification code 10055218 Term: Ischemic heart disease System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10047281 Term: Ventricular arrhythmia System Organ Class: 10007541 - Cardiac disorders MedDRA ver

Interventions

Product Name: Eleclazine white 6 mg tablets Product Code: [GS-6155 white 6 mg tablets] Pharmaceutical Form: Film-coated tablet CAS Number: 1443211-72-0 Current Sponsor code: GS-6615 Other descriptive

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria: There are no exclusion criteria for this study

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Denmark, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Poland, United Kingdom, United States

Contacts

Public ContactClinical Trials Mailbox

Gilead Sciences International Ltd.

clinical.trials@gilead.com+441223897284

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026