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Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination Administered in Patients Infected With Chronic Genotype 1 or 4 HCV for Use in the Peri-Operative Liver Transplantation Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02350569
Recruitment Status : Completed
First Posted : January 29, 2015
Results First Posted : May 5, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C Virus Infection
Intervention Drug: LDV/SOF
Enrollment 17
Recruitment Details Participants were enrolled at study sites in the United States. The first participant was screened on 22 May 2015. The last study visit occurred on 22 April 2016.
Pre-assignment Details 36 participants were screened. 17 unique participants were enrolled into the study (3 received the Day -1 dose and had their transplant cancelled; 2 of these patients were re-enrolled into the Main Study; the 3rd was rescreened but not transplanted).
Arm/Group Title LDV/SOF
Hide Arm/Group Description

LDV/SOF for 1 Day: 3 participants were called for transplant, received one dose of ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg), but had their liver transplant cancelled. All 3 participants were rescreened and 2 were subsequently re-enrolled, transplanted, and continued into the Main Study.

Main Study (LDV/SOF 4 Weeks): One dose of ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 hepatitis C virus (HCV) infection.

Retreatment (LDV/SOF 12 Weeks): Participants who completed treatment in the Main Study and experienced virologic failure had the option to be retreated with LDV/SOF for 12 weeks.

Period Title: Main Study (LDV/SOF 4 Weeks)
Started 16
Completed 16 [1]
Not Completed 0
[1]
1 participant discontinued treatment, but completed follow-up visits and study.
Period Title: Retreatment (LDV/SOF 12 Weeks)
Started 1 [1]
Completed 1
Not Completed 0
[1]
1 completed treatment (Main Study), experienced virologic failure, and entered Retreatment Phase
Arm/Group Title Main Study (LDV/SOF 4 Weeks)
Hide Arm/Group Description One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug during the Main Study
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
59  (5.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
8
  50.0%
Male
8
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Hispanic or Latino
4
  25.0%
Not Hispanic or Latino
12
  75.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   6.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
  12.5%
White
13
  81.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
HCV Genotype  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Genotype 1a
11
  68.8%
Genotype 1b
5
  31.3%
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
CC
5
  31.3%
CT
9
  56.3%
TT
2
  12.5%
[1]
Measure Description: The CC, CT, and TT alleles are different forms of the IL28b gene.
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 16 participants
5.6  (0.75)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
< 800,000 IU/mL
10
  62.5%
≥ 800,000 IU/mL
6
  37.5%
Prior HCV Treatment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
No
9
  56.3%
Yes
7
  43.8%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug
Arm/Group Title Main Study (LDV/SOF 4 Weeks)
Hide Arm/Group Description:
One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87.5
(61.7 to 98.4)
2.Primary Outcome
Title Percentage of Participants Who Prematurely Discontinued Study Drug Due to an Adverse Event
Hide Description [Not Specified]
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
Arm/Group Title Main Study (LDV/SOF 4 Weeks)
Hide Arm/Group Description:
One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
0
3.Secondary Outcome
Title Percentage of Participants With SVR 4 Weeks After Discontinuation of Therapy (SVR4)
Hide Description SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment.
Time Frame Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug
Arm/Group Title Main Study (LDV/SOF 4 Weeks)
Hide Arm/Group Description:
One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
87.5
(61.7 to 98.4)
4.Secondary Outcome
Title Percentage of Participants With Virologic Failure
Hide Description

Virologic failure was defined as:

  • End of treatment virologic failure:

    • Completed 28 days LDV/SOF treatment and had HCV RNA ≥ LLOQ at last measurement on treatment
  • Virologic relapse:

    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment HCV RNA measurement.
Time Frame Up to Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants who were enrolled into the study, received a liver transplant while on study, and received at least 1 dose of study drug
Arm/Group Title Main Study (LDV/SOF 4 Weeks)
Hide Arm/Group Description:
One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
6.3
5.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ While on Treatment at Days 1, 3, 5, 7, 14, 21, and 28
Hide Description [Not Specified]
Time Frame Days 1, 3, 5, 7, 14, 21, and 28
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title Main Study (LDV/SOF 4 Weeks)
Hide Arm/Group Description:
One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
Overall Number of Participants Analyzed 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Day 1 Number Analyzed 16 participants
0
(0.0 to 20.6)
Day 3 Number Analyzed 16 participants
12.5
(1.6 to 38.3)
Day 5 Number Analyzed 16 participants
18.8
(4.0 to 45.6)
Day 7 Number Analyzed 15 participants
33.3
(11.8 to 61.6)
Day 14 Number Analyzed 15 participants
93.3
(68.1 to 99.8)
Day 21 Number Analyzed 15 participants
100.0
(78.2 to 100.0)
Day 28 Number Analyzed 15 participants
100.0
(78.2 to 100.0)
Time Frame LDV/SOF for 1 Day: After pre-dose to minimum of 30 days or restart of LDV/SOF; Main Study: After pretransplant dose up to 4 weeks plus 30 days; Retreatment: After pretransplant dose up to 12 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who were enrolled into the study and received at least 1 dose of study drug
 
Arm/Group Title LDV/SOF for 1 Day Main Study (LDV/SOF 4 Weeks) Retreatment (LDV/SOF 12 Weeks)
Hide Arm/Group Description Adverse events reported in this group include participants who received LDV/SOF on Day -1, but did not receive a liver transplant. All 3 participants were rescreened, but only 2 were re-enrolled, transplanted, and received LDV/SOF for 4 weeks. Adverse events reported in this group include participants with chronic genotype 1 HCV infection who received one dose of LDV/SOF (90/400 mg) prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant. Adverse events reported in this group include 1 participant who completed treatment and experienced virologic failure in the Main Study and was retreated with an additional 12 weeks of LDV/SOF.
All-Cause Mortality
LDV/SOF for 1 Day Main Study (LDV/SOF 4 Weeks) Retreatment (LDV/SOF 12 Weeks)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   0/16 (0.00%)   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
LDV/SOF for 1 Day Main Study (LDV/SOF 4 Weeks) Retreatment (LDV/SOF 12 Weeks)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   5/16 (31.25%)   0/1 (0.00%) 
Hepatobiliary disorders       
Bile duct stenosis  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Cholangitis  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Infections and infestations       
Incision site cellulitis  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Injury, poisoning and procedural complications       
Biliary anastomosis complication  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Investigations       
Blood creatinine increased  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Hepatic artery flow decreased  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Hyperkalaemia  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Renal and urinary disorders       
Acute kidney injury  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF for 1 Day Main Study (LDV/SOF 4 Weeks) Retreatment (LDV/SOF 12 Weeks)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/3 (33.33%)   14/16 (87.50%)   1/1 (100.00%) 
Blood and lymphatic system disorders       
Anaemia  1  0/3 (0.00%)  5/16 (31.25%)  0/1 (0.00%) 
Leukocytosis  1  0/3 (0.00%)  2/16 (12.50%)  0/1 (0.00%) 
Thrombocytopenia  1  0/3 (0.00%)  2/16 (12.50%)  0/1 (0.00%) 
Ear and labyrinth disorders       
Ear pain  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Tinnitus  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Eye disorders       
Detachment of retinal pigment epithelium  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Dry eye  1  0/3 (0.00%)  2/16 (12.50%)  0/1 (0.00%) 
Ocular icterus  1  0/3 (0.00%)  4/16 (25.00%)  0/1 (0.00%) 
Gastrointestinal disorders       
Abdominal distension  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Abdominal pain  1  0/3 (0.00%)  4/16 (25.00%)  1/1 (100.00%) 
Constipation  1  0/3 (0.00%)  5/16 (31.25%)  0/1 (0.00%) 
Diarrhoea  1  0/3 (0.00%)  3/16 (18.75%)  0/1 (0.00%) 
Nausea  1  0/3 (0.00%)  5/16 (31.25%)  0/1 (0.00%) 
General disorders       
Chills  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Drug withdrawal syndrome  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Fatigue  1  0/3 (0.00%)  3/16 (18.75%)  0/1 (0.00%) 
Impaired healing  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Oedema  1  0/3 (0.00%)  5/16 (31.25%)  0/1 (0.00%) 
Peripheral swelling  1  0/3 (0.00%)  2/16 (12.50%)  0/1 (0.00%) 
Pyrexia  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Hepatobiliary disorders       
Cholestasis  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Hyperbilirubinaemia  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Jaundice  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Immune system disorders       
Transplant rejection  1  0/3 (0.00%)  2/16 (12.50%)  0/1 (0.00%) 
Infections and infestations       
Upper respiratory tract infection  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Wound infection  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Injury, poisoning and procedural complications       
Incision site complication  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Incision site pain  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Post procedural complication  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Procedural pain  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Wound  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Investigations       
Alanine aminotransferase increased  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Aspartate aminotransferase increased  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Blood alkaline phosphatase increased  1  0/3 (0.00%)  2/16 (12.50%)  0/1 (0.00%) 
Blood bilirubin increased  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Blood creatinine increased  1  0/3 (0.00%)  2/16 (12.50%)  0/1 (0.00%) 
Electrocardiogram ST segment elevation  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Gamma-glutamyltransferase increased  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Liver function test abnormal  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Urine output decreased  1  0/3 (0.00%)  3/16 (18.75%)  0/1 (0.00%) 
Metabolism and nutrition disorders       
Appetite disorder  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Cachexia  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Decreased appetite  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Diabetes mellitus  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Hypercalcaemia  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Hyperglycaemia  1  0/3 (0.00%)  7/16 (43.75%)  0/1 (0.00%) 
Hyperphosphataemia  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Hypervolaemia  1  0/3 (0.00%)  4/16 (25.00%)  0/1 (0.00%) 
Hypoalbuminaemia  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Hypoglycaemia  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Hypokalaemia  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Hypomagnesaemia  1  0/3 (0.00%)  2/16 (12.50%)  0/1 (0.00%) 
Hyponatraemia  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Hypophosphataemia  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Malnutrition  1  0/3 (0.00%)  5/16 (31.25%)  0/1 (0.00%) 
Metabolic acidosis  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Vitamin D deficiency  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Nervous system disorders       
Disturbance in attention  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Dizziness  1  0/3 (0.00%)  3/16 (18.75%)  0/1 (0.00%) 
Dizziness postural  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Headache  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Neuropathy peripheral  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Psychiatric disorders       
Adjustment disorder with depressed mood  1  1/3 (33.33%)  1/16 (6.25%)  0/1 (0.00%) 
Anxiety  1  0/3 (0.00%)  2/16 (12.50%)  0/1 (0.00%) 
Insomnia  1  0/3 (0.00%)  3/16 (18.75%)  0/1 (0.00%) 
Mental status changes  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Renal and urinary disorders       
Acute kidney injury  1  0/3 (0.00%)  5/16 (31.25%)  0/1 (0.00%) 
Haematuria  1  0/3 (0.00%)  2/16 (12.50%)  0/1 (0.00%) 
Micturition frequency decreased  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Reproductive system and breast disorders       
Scrotal swelling  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Acute respiratory failure  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Dyspnoea  1  0/3 (0.00%)  3/16 (18.75%)  0/1 (0.00%) 
Hypoxia  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Pleural effusion  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Pneumothorax  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Pulmonary oedema  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Rales  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Respiratory distress  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Wheezing  1  0/3 (0.00%)  2/16 (12.50%)  0/1 (0.00%) 
Skin and subcutaneous tissue disorders       
Acne  1  0/3 (0.00%)  0/16 (0.00%)  1/1 (100.00%) 
Hair growth abnormal  1  0/3 (0.00%)  0/16 (0.00%)  1/1 (100.00%) 
Pruritus  1  0/3 (0.00%)  0/16 (0.00%)  1/1 (100.00%) 
Rash  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Vascular disorders       
Deep vein thrombosis  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Flushing  1  0/3 (0.00%)  1/16 (6.25%)  0/1 (0.00%) 
Hypertension  1  0/3 (0.00%)  5/16 (31.25%)  0/1 (0.00%) 
Hypotension  1  0/3 (0.00%)  2/16 (12.50%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
EMail: ClinicalTrialDisclosures@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02350569     History of Changes
Other Study ID Numbers: GS-US-337-1428
First Submitted: January 26, 2015
First Posted: January 29, 2015
Results First Submitted: March 27, 2017
Results First Posted: May 5, 2017
Last Update Posted: November 19, 2018