Study of Females Exposed to Eleclazine

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003958-86-NL

Enrollment

177

Registered

2022-12-22

Start date

2023-05-26

Completion date

Unknown

Last updated

2024-03-12

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 10020871 Term: Hypertrophic cardiomyopathy System Organ Class: 10010331 - Congenital, familial and

Interventions

Product Name: Eleclazine white 10 mg tablets Product Code: GS-6615 white 10 mg tablets Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Eleclazine CAS Number: 1443211-72-0 Current Sponsor

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

—

Secondary

Measure	Time frame
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.	—

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