Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy (POLARIS-1)

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: NCT02607735
Recruitment Status : Completed
First Posted : November 18, 2015
Results First Posted : December 13, 2017
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: SOF/VEL/VOX
Drug: Placebo
Enrollment 416
Recruitment Details Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 11 November 2015. The last study visit occurred on 21 June 2017.
Pre-assignment Details 520 participants were screened.
Arm/Group Title SOF/VEL/VOX (Primary Study) Placebo (Primary Study) SOF/VEL/VOX (Deferred Treatment Substudy)
Hide Arm/Group Description Sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) (400/100/100 mg) fixed-dose combination (FDC) tablet orally once daily with food for 12 weeks Placebo tablet orally once daily with food for 12 weeks Participants who completed placebo treatment were eligible to enroll in to the open-label Deferred Treatment Substudy to receive SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks.
Period Title: Primary Study
Started 264 152 0
Completed 257 152 0
Not Completed 7 0 0
Reason Not Completed
Randomized but Never Treated             1             0             0
Lost to Follow-up             4             0             0
Withdrew Consent             2             0             0
Period Title: Deferred Treatment Substudy
Started 0 0 147
Completed 0 0 142
Not Completed 0 0 5
Reason Not Completed
Lost to Follow-up             0             0             4
Withdrew Consent             0             0             1
Arm/Group Title SOF/VEL/VOX (Primary Study) Placebo (Primary Study) Total
Hide Arm/Group Description SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks Placebo tablet orally once daily with food for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 263 152 415
Hide Baseline Analysis Population Description
Safety Analysis Set: all participants who received at least 1 dose of study drug
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 263 participants 152 participants 415 participants
58  (8.5) 59  (8.0) 58  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 152 participants 415 participants
Female
63
  24.0%
31
  20.4%
94
  22.7%
Male
200
  76.0%
121
  79.6%
321
  77.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 152 participants 415 participants
White
211
  80.2%
124
  81.6%
335
  80.7%
Black or African American
38
  14.4%
22
  14.5%
60
  14.5%
Asian
8
   3.0%
6
   3.9%
14
   3.4%
Native Hawaiian or Pacific Islander
3
   1.1%
0
   0.0%
3
   0.7%
Not Disclosed
1
   0.4%
0
   0.0%
1
   0.2%
American Indian or Alaska Native
1
   0.4%
0
   0.0%
1
   0.2%
Other
1
   0.4%
0
   0.0%
1
   0.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 152 participants 415 participants
Hispanic or Latino
15
   5.7%
10
   6.6%
25
   6.0%
Not Hispanic or Latino
247
  93.9%
142
  93.4%
389
  93.7%
Not Disclosed
1
   0.4%
0
   0.0%
1
   0.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 152 participants 415 participants
United States
135
  51.3%
101
  66.4%
236
  56.9%
Australia
15
   5.7%
11
   7.2%
26
   6.3%
Canada
28
  10.6%
14
   9.2%
42
  10.1%
France
56
  21.3%
16
  10.5%
72
  17.3%
Germany
16
   6.1%
7
   4.6%
23
   5.5%
New Zealand
5
   1.9%
2
   1.3%
7
   1.7%
United Kingdom
8
   3.0%
1
   0.7%
9
   2.2%
IL28b Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 152 participants 415 participants
CC
47
  17.9%
27
  17.8%
74
  17.8%
CT
165
  62.7%
93
  61.2%
258
  62.2%
TT
51
  19.4%
32
  21.1%
83
  20.0%
[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 263 participants 152 participants 415 participants
6.3  (0.68) 6.3  (0.63) 6.3  (0.66)
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 263 participants 152 participants 415 participants
< 800,000 IU/mL
73
  27.8%
36
  23.7%
109
  26.3%
≥ 800,000 IU/mL
190
  72.2%
116
  76.3%
306
  73.7%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping study treatment.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set (all randomized/enrolled participants who took at least 1 dose of study drug) in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 12 visit.
Arm/Group Title SOF/VEL/VOX (Primary Study)
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
Overall Number of Participants Analyzed 263
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.2
(93.1 to 98.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SOF/VEL/VOX (Primary Study)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments The SVR12 rate for the SOF/VEL/VOX group was compared to the performance goal of 85% using a 2-sided exact 1-sample binomial test at the 0.05 significance level.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method 2-sided exact 1-sample binomial test
Comments [Not Specified]
2.Primary Outcome
Title Percentage of Participants Who Permanently Discontinued Study Drug Due to an Adverse Event (Primary Study)
Hide Description [Not Specified]
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title SOF/VEL/VOX (Primary Study) Placebo (Primary Study)
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
Placebo tablet orally once daily with food for 12 weeks
Overall Number of Participants Analyzed 263 152
Measure Type: Number
Unit of Measure: percentage of participants
0.4 2.0
3.Secondary Outcome
Title Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4) (Primary Study)
Hide Description SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping study treatment, respectively.
Time Frame Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF/VEL/VOX (Primary Study) Placebo (Primary Study)
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
Placebo tablet orally once daily with food for 12 weeks
Overall Number of Participants Analyzed 263 152
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
97.7
(95.1 to 99.2)
0
(0.0 to 2.4)
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ On Treatment (Primary Study)
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL/VOX (Primary Study) Placebo (Primary Study)
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
Placebo tablet orally once daily with food for 12 weeks
Overall Number of Participants Analyzed 263 152
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 1 Number Analyzed 263 participants 152 participants
15.6
(11.4 to 20.5)
0
(0.0 to 2.4)
Week 2 Number Analyzed 263 participants 150 participants
56.7
(50.4 to 62.7)
0
(0.0 to 2.4)
Week 4 Number Analyzed 262 participants 150 participants
92.7
(88.9 to 95.6)
0
(0.0 to 2.4)
Week 8 Number Analyzed 262 participants 150 participants
100.0
(98.6 to 100.0)
0
(0.0 to 2.4)
Week 12 Number Analyzed 261 participants 149 participants
99.6
(97.9 to 100.0)
0
(0.0 to 2.4)
5.Secondary Outcome
Title Change From Baseline in HCV RNA (Primary Study)
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 2, 4, 8 and 12
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with available data were analyzed.
Arm/Group Title SOF/VEL/VOX (Primary Study) Placebo (Primary Study)
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
Placebo tablet orally once daily with food for 12 weeks
Overall Number of Participants Analyzed 262 150
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Week 1 Number Analyzed 258 participants 150 participants
-4.20  (0.733) 0.02  (0.300)
Week 2 Number Analyzed 261 participants 148 participants
-4.81  (0.704) 0.02  (0.322)
Week 4 Number Analyzed 261 participants 150 participants
-5.07  (0.677) -0.01  (0.441)
Week 8 Number Analyzed 262 participants 149 participants
-5.11  (0.678) 0.05  (0.434)
Week 12 Number Analyzed 261 participants 138 participants
-5.10  (0.690) 0.03  (0.430)
6.Secondary Outcome
Title Percentage of Participants With SVR at 24 Weeks After Discontinuation of Therapy (SVR24) (Primary Study)
Hide Description SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.
Time Frame Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 24 visit.
Arm/Group Title SOF/VEL/VOX (Primary Study)
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
Overall Number of Participants Analyzed 263
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
96.2
(93.1 to 98.2)
7.Secondary Outcome
Title Percentage of Participants With Virologic Failure (Primary Study)
Hide Description

Virologic failure is defined as:

  • On-treatment virologic failure:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA LLOQ while on treatment), or
    • Rebound (confirmed 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
  • Virologic relapse:

    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA LLOQ at last on-treatment visit.
Time Frame Up to Posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set in the SOF/VEL/VOX group were analyzed. This outcome measure was not assessed for participants in the Placebo group because they did not have a Posttreatment Week 24 visit.
Arm/Group Title SOF/VEL/VOX (Primary Study)
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
Overall Number of Participants Analyzed 263
Measure Type: Number
Unit of Measure: percentage of participants
2.7
8.Secondary Outcome
Title Percentage of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)
Hide Description SVR4, SVR12 and SVR24 was defined as HCV RNA < LLOQ at 4, 12 and 24 weeks after stopping study treatment, respectively.
Time Frame Posttreatment Weeks 4, 12, and 24 (Deferred Treatment Substudy)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title SOF/VEL/VOX (Deferred Treatment Substudy)
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
Overall Number of Participants Analyzed 147
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
SVR4
98.6
(95.2 to 99.8)
SVR12
97.3
(93.2 to 99.3)
SVR24
97.3
(93.2 to 99.3)
9.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)
Hide Description [Not Specified]
Time Frame Weeks 1, 2, 4, 8 and 12 (Deferred Treatment Substudy)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set from the Deferred Treatment Sub study: all enrolled participants who took at least 1 dose of study drug
Arm/Group Title SOF/VEL/VOX (Deferred Treatment Substudy)
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
Overall Number of Participants Analyzed 147
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Week 1
14.3
(9.1 to 21.0)
Week 2
62.6
(54.2 to 70.4)
Week 4
93.2
(87.8 to 96.7)
Week 8
100.0
(97.5 to 100.0)
Week 12
100.0
(97.5 to 100.0)
10.Secondary Outcome
Title Change From Baseline in HCV RNA (Deferred Treatment Substudy)
Hide Description [Not Specified]
Time Frame Baseline; Weeks 1, 2, 4, 8, and 12 (Deferred Treatment Substudy)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with available data in the Full Analysis Set of the Deferred Treatment Substudy were analyzed.
Arm/Group Title SOF/VEL/VOX (Deferred Treatment Substudy)
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
Overall Number of Participants Analyzed 147
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
Week 1 Number Analyzed 139 participants
-4.30  (0.626)
Week 2 Number Analyzed 145 participants
-4.93  (0.602)
Week 4 Number Analyzed 147 participants
-5.16  (0.512)
Week 8 Number Analyzed 147 participants
-5.20  (0.532)
Week 12 Number Analyzed 147 participants
-5.20  (0.532)
11.Secondary Outcome
Title Percentage of Participants With Virologic Failure (Deferred Treatment Substudy)
Hide Description

Virologic failure is defined as:

  • On-treatment virologic failure:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA LLOQ while on treatment), or
    • Rebound (confirmed 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
  • Virologic relapse:

    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA LLOQ at last on-treatment visit.
Time Frame Up to Posttreatment Week 24 (Deferred Treatment Substudy)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set in the Deferred Treatment Substudy
Arm/Group Title SOF/VEL/VOX (Deferred Treatment Substudy)
Hide Arm/Group Description:
SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks
Overall Number of Participants Analyzed 147
Measure Type: Number
Unit of Measure: percentage of participants
2.7
Time Frame Primary Study: Up to 12 Weeks + 30 days; Deferred Treatment Substudy: Up to 12 Weeks + 30 days
Adverse Event Reporting Description Safety Analysis Set: all participants who received at least 1 dose of study drug
 
Arm/Group Title SOF/VEL/VOX (Primary Study) Placebo (Primary Study) SOF/VEL/VOX (Deferred Treatment Substudy)
Hide Arm/Group Description SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks Placebo tablet orally once daily with food for 12 weeks

Participants who completed placebo treatment were eligible for open-label Deferred Treatment Substudy.

SOF/VEL/VOX (400/100/100 mg) FDC tablet orally once daily with food for 12 weeks

All-Cause Mortality
SOF/VEL/VOX (Primary Study) Placebo (Primary Study) SOF/VEL/VOX (Deferred Treatment Substudy)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/263 (0.00%)   0/152 (0.00%)   0/147 (0.00%) 
Hide Serious Adverse Events
SOF/VEL/VOX (Primary Study) Placebo (Primary Study) SOF/VEL/VOX (Deferred Treatment Substudy)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/263 (1.90%)   7/152 (4.61%)   6/147 (4.08%) 
Cardiac disorders       
Acute myocardial infarction  1  0/263 (0.00%)  0/152 (0.00%)  1/147 (0.68%) 
Atrial fibrillation  1  0/263 (0.00%)  1/152 (0.66%)  0/147 (0.00%) 
Ventricular fibrillation  1  0/263 (0.00%)  1/152 (0.66%)  0/147 (0.00%) 
Gastrointestinal disorders       
Mesenteric vein thrombosis  1  0/263 (0.00%)  0/152 (0.00%)  1/147 (0.68%) 
Hepatobiliary disorders       
Hepatic failure  1  0/263 (0.00%)  1/152 (0.66%)  0/147 (0.00%) 
Infections and infestations       
Pneumonia  1  1/263 (0.38%)  0/152 (0.00%)  0/147 (0.00%) 
Scrotal infection  1  0/263 (0.00%)  1/152 (0.66%)  0/147 (0.00%) 
Urosepsis  1  0/263 (0.00%)  0/152 (0.00%)  1/147 (0.68%) 
Injury, poisoning and procedural complications       
Subdural haematoma  1  0/263 (0.00%)  1/152 (0.66%)  0/147 (0.00%) 
Wrist fracture  1  0/263 (0.00%)  0/152 (0.00%)  1/147 (0.68%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Adrenal neoplasm  1  1/263 (0.38%)  0/152 (0.00%)  0/147 (0.00%) 
Basal cell carcinoma  1  0/263 (0.00%)  1/152 (0.66%)  0/147 (0.00%) 
Hepatocellular carcinoma  1  0/263 (0.00%)  0/152 (0.00%)  1/147 (0.68%) 
Ovarian cancer  1  1/263 (0.38%)  0/152 (0.00%)  0/147 (0.00%) 
Nervous system disorders       
Cerebral haemorrhage  1  1/263 (0.38%)  0/152 (0.00%)  0/147 (0.00%) 
Generalised tonic-clonic seizure  1  0/263 (0.00%)  0/152 (0.00%)  1/147 (0.68%) 
Seizure  1  1/263 (0.38%)  0/152 (0.00%)  0/147 (0.00%) 
Psychiatric disorders       
Schizophrenia  1  0/263 (0.00%)  1/152 (0.66%)  0/147 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis  1  0/263 (0.00%)  0/152 (0.00%)  1/147 (0.68%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease  1  1/263 (0.38%)  0/152 (0.00%)  0/147 (0.00%) 
Vascular disorders       
Arteritis  1  1/263 (0.38%)  0/152 (0.00%)  0/147 (0.00%) 
1
Term from vocabulary, MedDRA (20.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SOF/VEL/VOX (Primary Study) Placebo (Primary Study) SOF/VEL/VOX (Deferred Treatment Substudy)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   147/263 (55.89%)   80/152 (52.63%)   87/147 (59.18%) 
Gastrointestinal disorders       
Diarrhoea  1  48/263 (18.25%)  19/152 (12.50%)  28/147 (19.05%) 
Nausea  1  37/263 (14.07%)  12/152 (7.89%)  21/147 (14.29%) 
General disorders       
Asthenia  1  20/263 (7.60%)  9/152 (5.92%)  3/147 (2.04%) 
Fatigue  1  56/263 (21.29%)  30/152 (19.74%)  31/147 (21.09%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  8/263 (3.04%)  8/152 (5.26%)  9/147 (6.12%) 
Back pain  1  11/263 (4.18%)  8/152 (5.26%)  7/147 (4.76%) 
Nervous system disorders       
Dizziness  1  11/263 (4.18%)  14/152 (9.21%)  7/147 (4.76%) 
Headache  1  66/263 (25.10%)  26/152 (17.11%)  29/147 (19.73%) 
Psychiatric disorders       
Insomnia  1  19/263 (7.22%)  8/152 (5.26%)  5/147 (3.40%) 
1
Term from vocabulary, MedDRA (20.0)
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: Gilead Clinical Study Information Center
Organization: Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
EMail: GileadClinicalTrials@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02607735    
Other Study ID Numbers: GS-US-367-1171
2015-003455-21 ( EudraCT Number )
First Submitted: November 16, 2015
First Posted: November 18, 2015
Results First Submitted: October 4, 2017
Results First Posted: December 13, 2017
Last Update Posted: March 5, 2019