Trial Outcomes & Findings for Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3 (NCT NCT02300558)
NCT ID: NCT02300558
Last Updated: 2018-01-12
Results Overview
* Baseline was the Day 1 value. * QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds. * AUC0-6 for QTcF was calculated using the trapezoidal rule, mean of triplicate values, and actual time (latest of triplicate times). * Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from dosing to the 6 hour postdose time point.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
41 participants
Primary outcome timeframe
Baseline; Week 24
Results posted on
2018-01-12
Participant Flow
Participants were enrolled at study sites in North America, Europe, and Asia. The first participant was screened on 17 December 2014. The last study visit occurred on 15 February 2017.
54 participants were screened.
Participant milestones
| Measure |
Eleclazine
* Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24
* Open-label Extension (OLE): Eleclazine 6 mg or 3 mg tablets orally once daily
|
|---|---|
|
Single Blind Phase (24 Weeks)
STARTED
|
41
|
|
Single Blind Phase (24 Weeks)
COMPLETED
|
35
|
|
Single Blind Phase (24 Weeks)
NOT COMPLETED
|
6
|
|
Open-Label (OL) Extension Phase
STARTED
|
32
|
|
Open-Label (OL) Extension Phase
COMPLETED
|
0
|
|
Open-Label (OL) Extension Phase
NOT COMPLETED
|
32
|
Reasons for withdrawal
| Measure |
Eleclazine
* Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24
* Open-label Extension (OLE): Eleclazine 6 mg or 3 mg tablets orally once daily
|
|---|---|
|
Single Blind Phase (24 Weeks)
Study Terminated by Sponsor
|
6
|
|
Open-Label (OL) Extension Phase
Lack of Efficacy
|
2
|
|
Open-Label (OL) Extension Phase
Withdrew Consent
|
1
|
|
Open-Label (OL) Extension Phase
Study Terminated by Sponsor
|
29
|
Baseline Characteristics
Effect of Eleclazine on Shortening of the QT Interval, Safety, and Tolerability in Adults With Long QT Syndrome Type 3
Baseline characteristics by cohort
| Measure |
Eleclazine
n=41 Participants
* Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24
* OLE: Eleclazine 6 mg or 3 mg tablets orally once daily
|
|---|---|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
46 Years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
White
|
36 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Permitted
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
40 Participants
n=99 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
Netherlands
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=99 Participants
|
|
Region of Enrollment
Italy
|
12 Participants
n=99 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
Israel
|
3 Participants
n=99 Participants
|
|
Region of Enrollment
France
|
9 Participants
n=99 Participants
|
|
Region of Enrollment
Germany
|
1 Participants
n=99 Participants
|
|
Mean Daytime QTcF Lead V5 (Standard 12-lead ECG)
|
507.5 msec
STANDARD_DEVIATION 38.11 • n=99 Participants
|
|
Mean Daily QTcF in Lead V5 (Holter)
|
514.7 msec
STANDARD_DEVIATION 45.76 • n=99 Participants
|
|
Mean Nocturnal QTcF in Lead V5 (Holter)
|
530.6 msec
STANDARD_DEVIATION 52.25 • n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 24Population: Participants in Full Analysis Set (FAS) with available data were analyzed. FAS was defined as all enrolled participants who have confirmed LQT3 genotype, do not have confirmed LQT1 or LQT2 mutations, received at least 1 dose of active eleclazine, and have both a baseline and at least 1 postbaseline mean daytime QTcF interval (standard 12-lead).
* Baseline was the Day 1 value. * QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds. * AUC0-6 for QTcF was calculated using the trapezoidal rule, mean of triplicate values, and actual time (latest of triplicate times). * Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from dosing to the 6 hour postdose time point.
Outcome measures
| Measure |
Eleclazine
n=35 Participants
* Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24
* OLE: Eleclazine 6 mg or 3 mg tablets orally once daily
|
|---|---|
|
Change From Baseline in Mean Daytime QT Interval in Lead V5 Corrected for Heart Rate Using the Fridericia Formula (QTcF) Interval to Week 24 (Based on Standard 12-lead ECG Data)
|
-8.5 msec
Standard Deviation 18.03
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set with available data were analyzed.
* Baseline was the Day 1 value. * QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds. * AUC0-6 for QTcF was calculated using the trapezoidal rule, mean of triplicate values, and actual time (latest of triplicate times) . * Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from dosing to the 6 hour postdose time point.
Outcome measures
| Measure |
Eleclazine
n=40 Participants
* Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24
* OLE: Eleclazine 6 mg or 3 mg tablets orally once daily
|
|---|---|
|
Change From Baseline in Mean Daytime QTcF Interval (AUC0-6/6) to Week 12 (Lead V5; Standard 12-lead ECG)
|
2.2 msec
Interval -4.7 to 9.2
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
* Baseline was the Day 1 value. * QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds. * Mean daytime QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from predose to 6 hours postdose. Mean nocturnal QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from midnight to 6:00 AM. Daily was computed as the average of daytime (AUC0-6/6) and nocturnal (AUC0-6/6), with both values required to compute the average.
Outcome measures
| Measure |
Eleclazine
n=30 Participants
* Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24
* OLE: Eleclazine 6 mg or 3 mg tablets orally once daily
|
|---|---|
|
Change From Baseline in Mean Daily (Daytime and Nocturnal) QTcF Interval to Week 24 (Lead V5; Holter)
|
-1.8 msec
Interval -13.6 to 10.0
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the the Full Analysis Set with available data were analyzed.
* Baseline was the Day 1 value. * QTcF is corrected QT interval using Fridericia's formula. QTcF = QT/cube root (RR), where RR is in seconds. * Mean nocturnal QTcF (AUC0-6/6) was computed by dividing AUC0-6 by the time from the first nonmissing nominal time point to the last nonmissing nominal time point, from midnight to 6:00 AM.
Outcome measures
| Measure |
Eleclazine
n=31 Participants
* Single-Blind Treatment Period: Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1; eleclazine 48 mg ( 8 x 6 mg tablets) on Day 2; followed by eleclazine 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit; then once daily maintenance dose of eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24
* OLE: Eleclazine 6 mg or 3 mg tablets orally once daily
|
|---|---|
|
Change From Baseline in Mean Nocturnal QTcF Interval to Week 24 (Lead V5; Holter)
|
-3.0 msec
Interval -17.1 to 11.0
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Eleclazine Loading Dose (LD) 48 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Eleclazine Maintenance Dose (MD) 3 mg
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Eleclazine MD 6 mg
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
All Eleclazine
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=41 participants at risk
Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1
|
Eleclazine Loading Dose (LD) 48 mg
n=41 participants at risk
Eleclazine 48 mg ( 8 x 6 mg tablets) administered orally on Day 2
|
Eleclazine Maintenance Dose (MD) 3 mg
n=41 participants at risk
Eleclazine 3 mg (1 x 3 mg tablet) administered once daily from Day 3 to the Week 12 Visit
|
Eleclazine MD 6 mg
n=41 participants at risk
Eleclazine 6 mg (1 x 6 mg tablet) administered orally from the day after the Week 12 Visit through Week 24 and open-label extension.
|
All Eleclazine
n=41 participants at risk
* Loading Dose: Eleclazine 48 mg ( 8 x 6 mg tablets) administered on Day 2 and 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit
* Maintenance dose: Eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24 and open-label extension.
Adverse events in this reporting group include those that occurred any time during the study by participants while receiving loading dose or maintenance dose of eleclazine.
|
|---|---|---|---|---|---|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
2.4%
1/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
2.4%
1/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
Other adverse events
| Measure |
Placebo
n=41 participants at risk
Single oral loading dose of placebo to match eleclazine loading dose (8 x 6 mg placebo to match tablets) on Day 1
|
Eleclazine Loading Dose (LD) 48 mg
n=41 participants at risk
Eleclazine 48 mg ( 8 x 6 mg tablets) administered orally on Day 2
|
Eleclazine Maintenance Dose (MD) 3 mg
n=41 participants at risk
Eleclazine 3 mg (1 x 3 mg tablet) administered once daily from Day 3 to the Week 12 Visit
|
Eleclazine MD 6 mg
n=41 participants at risk
Eleclazine 6 mg (1 x 6 mg tablet) administered orally from the day after the Week 12 Visit through Week 24 and open-label extension.
|
All Eleclazine
n=41 participants at risk
* Loading Dose: Eleclazine 48 mg ( 8 x 6 mg tablets) administered on Day 2 and 3 mg (1 x 3 mg tablet) once daily from Day 3 to the Week 12 Visit
* Maintenance dose: Eleclazine 6 mg (1 x 6 mg tablet) from the day after the Week 12 Visit through Week 24 and open-label extension.
Adverse events in this reporting group include those that occurred any time during the study by participants while receiving loading dose or maintenance dose of eleclazine.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
2.4%
1/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
4.9%
2/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
4.9%
2/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
7.3%
3/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
7.3%
3/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
2.4%
1/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
9.8%
4/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
2.4%
1/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
7.3%
3/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
9.8%
4/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
|
General disorders
Asthenia
|
2.4%
1/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
4.9%
2/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
2.4%
1/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
7.3%
3/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
|
General disorders
Fatigue
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
7.3%
3/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
4.9%
2/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
12.2%
5/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
|
Infections and infestations
Influenza
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
7.3%
3/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
7.3%
3/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
14.6%
6/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
4.9%
2/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
4.9%
2/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
9.8%
4/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
|
Investigations
Weight increased
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
2.4%
1/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
4.9%
2/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
7.3%
3/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.4%
1/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
4.9%
2/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
4.9%
2/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
7.3%
3/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
7.3%
3/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
|
Nervous system disorders
Dizziness
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
4.9%
2/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
4.9%
2/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
0.00%
0/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
9.8%
4/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
|
Nervous system disorders
Headache
|
4.9%
2/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
2.4%
1/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
4.9%
2/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
9.8%
4/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
14.6%
6/41 • Day 1 to the last dose date plus 30 days (median exposure to eleclazine: 396 days)
Safety Analysis Set
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER