Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 22 of 115 for:    "Viral Infectious Disease" | "Ledipasvir"

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)

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: NCT01851330
Recruitment Status : Completed
First Posted : May 10, 2013
Results First Posted : December 30, 2014
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C Virus
Interventions Drug: LDV/SOF
Drug: RBV
Enrollment 647
Recruitment Details Participants were enrolled at a total of 59 study sites in the United States. The first participant was screened on 06 May 2013. The last participant observation occurred on 07 March 2014.
Pre-assignment Details 831 participants were screened.
Arm/Group Title LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Hide Arm/Group Description Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 8 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
Period Title: Overall Study
Started 215 216 216
Completed 202 200 204
Not Completed 13 16 12
Reason Not Completed
Lack of Efficacy             10             9             2
Lost to Follow-up             1             6             9
Withdrew Consent             2             1             0
Investigator’s Discretion             0             0             1
Arm/Group Title LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week Total
Hide Arm/Group Description LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 215 216 216 647
Hide Baseline Analysis Population Description
Safety Analysis Set: participants were randomized and received at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 215 participants 216 participants 216 participants 647 participants
53  (10.2) 51  (11.7) 53  (10.6) 52  (10.9)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 215 participants 216 participants 216 participants 647 participants
Female
85
  39.5%
99
  45.8%
88
  40.7%
272
  42.0%
Male
130
  60.5%
117
  54.2%
128
  59.3%
375
  58.0%
[1]
Measure Description: Gender was collected as "Sex at Birth."
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 215 participants 216 participants 216 participants 647 participants
Black or African American 45 36 42 123
White 164 176 167 507
Asian 5 2 3 10
American Indian/Alaska Native 0 1 0 1
Hawaiian or Pacific Islander 0 1 0 1
Other 1 0 3 4
Not Disclosed 0 0 1 1
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 215 participants 216 participants 216 participants 647 participants
Hispanic or Latino 13 12 14 39
Not Hispanic or Latino 200 204 202 606
Not Disclosed 2 0 0 2
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 215 participants 216 participants 216 participants 647 participants
6.5  (0.76) 6.4  (0.69) 6.4  (0.76) 6.5  (0.74)
HCV RNA Category  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 215 participants 216 participants 216 participants 647 participants
< 800,000 IU/mL 34 45 44 123
≥ 800,000 IU/mL 181 171 172 524
HCV Genotype  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 215 participants 216 participants 216 participants 647 participants
Genotype 1 (no confirmed subtype) 1 0 0 1
Genotype 1a 171 172 172 515
Genotype 1b 43 44 44 131
IL28b Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 215 participants 216 participants 216 participants 647 participants
CC 56 60 56 172
CT 120 128 124 372
TT 39 28 36 103
[1]
Measure Description: CC, CT, and TT alleles are different forms of the IL28b gene.
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
Hide Description SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks following the last dose of study drug.
Time Frame Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set: participants were randomized and received at least one dose of study medication.
Arm/Group Title LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 215 216 216
Measure Type: Number
Unit of Measure: percentage of participants
94.0 93.1 96.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection LDV/SOF 8 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value for the comparison of the LDV/SOF 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.
Method Binomial test
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection LDV/SOF+RBV 8 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value for the comparison of the LDV/SOF+RBV 8 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.
Method Binomial test
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection LDV/SOF 12 Week
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The p-value for the comparison of the LDV/SOF 12 week group against the adjusted historical null rate (60%) was based on a 2-sided 1-sample binomial test.
Method Binomial test
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection LDV/SOF+RBV 8 Week, LDV/SOF 12 Week
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority would be demonstrated if the lower bound of the confidence interval (CI) for the difference between groups was greater than -12%.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value -3.2
Confidence Interval (2-Sided) 97.5%
-8.3 to 1.8
Estimation Comments Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection LDV/SOF 8 Week, LDV/SOF 12 Week
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value -2.3
Confidence Interval (2-Sided) 97.5%
-7.2 to 2.5
Estimation Comments Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection LDV/SOF 8 Week, LDV/SOF+RBV 8 Week
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Noninferiority would be demonstrated if the lower bound of the CI for the difference between groups was greater than -12%.
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.9
Confidence Interval (2-Sided) 95%
-3.9 to 5.7
Estimation Comments Difference in proportions between treatment groups and associated confidence interval (CI) were calculated based on stratum-adjusted Mantel-Haenszel proportions.
2.Primary Outcome
Title Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
Hide Description The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
Time Frame Up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set
Arm/Group Title LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 215 216 216
Measure Type: Number
Unit of Measure: percentage of participants
0 0.9 0.9
3.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Hide Description SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
Time Frame Posttreatment Weeks 4 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 215 216 216
Measure Type: Number
Unit of Measure: percentage of participants
SVR4 96.3 94.9 96.3
SVR24 94.0 93.1 96.3
4.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 2
Hide Description [Not Specified]
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with Available Data were analyzed.
Arm/Group Title LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 215 214 216
Measure Type: Number
Unit of Measure: percentage of participants
88.4 91.1 91.2
5.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 4
Hide Description [Not Specified]
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with Available Data were analyzed.
Arm/Group Title LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 216 213 216
Measure Type: Number
Unit of Measure: percentage of participants
100.0 99.1 100.0
6.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at Week 8
Hide Description [Not Specified]
Time Frame Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with Available Data were analyzed.
Arm/Group Title LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 215 213 214
Measure Type: Number
Unit of Measure: percentage of participants
100.0 100.0 99.5
7.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 2
Hide Description [Not Specified]
Time Frame Baseline; Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with Available Data were analyzed.
Arm/Group Title LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 215 212 212
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.06  (0.752) -5.01  (0.675) -4.99  (0.750)
8.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 4
Hide Description [Not Specified]
Time Frame Baseline; Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with Available Data were analyzed.
Arm/Group Title LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 215 212 216
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.12  (0.760) -5.05  (0.682) -5.05  (0.758)
9.Secondary Outcome
Title Change From Baseline in HCV RNA at Week 8
Hide Description [Not Specified]
Time Frame Baseline; Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the Full Analysis Set with Available Data were analyzed.
Arm/Group Title LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 215 213 213
Mean (Standard Deviation)
Unit of Measure: log10 IU/mL
-5.12  (0.760) -5.05  (0.683) -5.04  (0.761)
10.Secondary Outcome
Title Percentage of Participants Experiencing Virologic Failure
Hide Description

Virologic failure was defined as on-treatment virologic failure or virologic relapse.

  • On-Treatment Virologic Failure was defined as

    • 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 was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.
Time Frame Baseline to posttreatment Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Hide Arm/Group Description:
LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
Overall Number of Participants Analyzed 215 216 216
Measure Type: Number
Unit of Measure: percentage of participants
On-treatment virologic failure 0 0 0
Virologic relapse 5.1 4.2 1.4
Time Frame Up to 12 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set
 
Arm/Group Title LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Hide Arm/Group Description LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
All-Cause Mortality
LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   4/215 (1.86%)   1/216 (0.46%)   5/216 (2.31%) 
Gastrointestinal disorders       
Abdominal pain  1  0/215 (0.00%)  0/216 (0.00%)  1/216 (0.46%) 
Colitis  1  1/215 (0.47%)  0/216 (0.00%)  0/216 (0.00%) 
Lower gastrointestinal haemorrhage  1  1/215 (0.47%)  0/216 (0.00%)  0/216 (0.00%) 
Hepatobiliary disorders       
Bile duct stone  1  0/215 (0.00%)  0/216 (0.00%)  1/216 (0.46%) 
Jaundice  1  0/215 (0.00%)  0/216 (0.00%)  1/216 (0.46%) 
Immune system disorders       
Anaphylactic reaction  1  1/215 (0.47%)  0/216 (0.00%)  0/216 (0.00%) 
Injury, poisoning and procedural complications       
Road traffic accident  1  0/215 (0.00%)  0/216 (0.00%)  1/216 (0.46%) 
Skeletal injury  1  0/215 (0.00%)  0/216 (0.00%)  1/216 (0.46%) 
Metabolism and nutrition disorders       
Diabetes mellitus inadequate control  1  1/215 (0.47%)  0/216 (0.00%)  0/216 (0.00%) 
Hypoglycaemia  1  0/215 (0.00%)  0/216 (0.00%)  1/216 (0.46%) 
Musculoskeletal and connective tissue disorders       
Rhabdomyolysis  1  0/215 (0.00%)  0/216 (0.00%)  1/216 (0.46%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Pituitary tumour  1  0/215 (0.00%)  1/216 (0.46%)  0/216 (0.00%) 
Squamous cell carcinoma of lung  1  0/215 (0.00%)  0/216 (0.00%)  1/216 (0.46%) 
Psychiatric disorders       
Mental status changes  1  0/215 (0.00%)  0/216 (0.00%)  1/216 (0.46%) 
Respiratory, thoracic and mediastinal disorders       
Haemothorax 0  1  0/215 (0.00%)  0/216 (0.00%)  1/216 (0.46%) 
Respiratory failure  1  0/215 (0.00%)  0/216 (0.00%)  1/216 (0.46%) 
Vascular disorders       
Hypertension  1  1/215 (0.47%)  0/216 (0.00%)  0/216 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LDV/SOF 8 Week LDV/SOF+RBV 8 Week LDV/SOF 12 Week
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   146/215 (67.91%)   166/216 (76.85%)   150/216 (69.44%) 
Blood and lymphatic system disorders       
Anaemia  1  2/215 (0.93%)  17/216 (7.87%)  2/216 (0.93%) 
Gastrointestinal disorders       
Nausea  1  15/215 (6.98%)  39/216 (18.06%)  24/216 (11.11%) 
Diarrhoea  1  15/215 (6.98%)  13/216 (6.02%)  9/216 (4.17%) 
Constipation  1  9/215 (4.19%)  12/216 (5.56%)  8/216 (3.70%) 
General disorders       
Fatigue  1  45/215 (20.93%)  75/216 (34.72%)  49/216 (22.69%) 
Irritability  1  3/215 (1.40%)  29/216 (13.43%)  10/216 (4.63%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  9/215 (4.19%)  12/216 (5.56%)  16/216 (7.41%) 
Muscle spasms  1  3/215 (1.40%)  12/216 (5.56%)  6/216 (2.78%) 
Nervous system disorders       
Headache  1  30/215 (13.95%)  54/216 (25.00%)  33/216 (15.28%) 
Dizziness  1  6/215 (2.79%)  13/216 (6.02%)  9/216 (4.17%) 
Psychiatric disorders       
Insomnia  1  11/215 (5.12%)  26/216 (12.04%)  15/216 (6.94%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  3/215 (1.40%)  12/216 (5.56%)  7/216 (3.24%) 
Dyspnoea  1  0/215 (0.00%)  11/216 (5.09%)  1/216 (0.46%) 
Skin and subcutaneous tissue disorders       
Rash  1  3/215 (1.40%)  20/216 (9.26%)  5/216 (2.31%) 
Pruritus  1  2/215 (0.93%)  16/216 (7.41%)  5/216 (2.31%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (16.0)
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, Inc.
EMail: ClinicalTrialDisclosures@gilead.com
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01851330     History of Changes
Other Study ID Numbers: GS-US-337-0108
First Submitted: May 3, 2013
First Posted: May 10, 2013
Results First Submitted: December 18, 2014
Results First Posted: December 30, 2014
Last Update Posted: November 16, 2018