A study to see if GS-6615 shortens QT interval in patients with LQT3
Research type
Research Study
Full title
A Phase 3, Single-Blind Study to Evaluate the Effect of GS-6615 on Shortening of the QT Interval, Safety, and Tolerability in Subjects with Long QT-3 Syndrome
IRAS ID
162300
Contact name
Pier Lambiase
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2014-000042-30
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
114152, IND Number
Duration of Study in the UK
5 years, 7 months, 1 days
Research summary
This is a phase 3, single-blind study to evaluate the effect of GS-6615 on shortening of the QT interval, safety, and tolerability in subjects with type 3 long QT syndrome (LQTS). LQTS is an uncommon but serious heart condition resulting from disruption in the electrical activity of the heart. Doctors subdivide each heartbeat into five distinct electrical waves - P, Q, R, S and T. The pattern from Q to T represents the electrical activity of the lower chambers of the heart. In people with LQTS, this Q to T interval lasts abnormally long, meaning that it takes longer for the lower chambers to recharge after each heartbeat. LQTS can cause fainting and episodes of rapid and potentially dangerous heart rhythms. It is a leading cause of sudden cardiac death in young, otherwise healthy people.
GS-6615 is a new, investigational drug designed to block the processes leading to QT interval prolongation. GS-6615 is being developed for the treatment of a particular subtype of LQTS, type 3 (LQT3). GS-6615 has previously been tested in humans. There have been no reports of serious or severe side effects related to taking GS-6615 to date.
The purpose of this study is to evaluate if GS-6615 shortens the QT interval in patients with LQT3. Part 1 is a single-blind treatment period. Patients will not know when they are taking active GS-6615 or placebo. Over a period of 24 weeks, patients will have approximately 6 clinic visits. Study-related procedures will include physical examinations, vital signs, ECG monitoring, and blood and urine samples. During Part 2, the open-label extension, all patients will receive active GS-6615 for up to 4.5 years.
This study is sponsored by Gilead Sciences, Inc. Approximately 40 patients will participate in this study worldwide with 3 patients enrolled from the Heart Hospital in London.
REC name
London - Brent Research Ethics Committee
REC reference
15/LO/0212
Date of REC Opinion
18 May 2015
REC opinion
Further Information Favourable Opinion