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Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment (Co-STARs)

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: NCT02707601
Recruitment Status : Completed
First Posted : March 14, 2016
Results First Posted : October 9, 2018
Last Update Posted : November 14, 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
Conditions HIV-1 Infection
HCV Infection
Interventions Drug: E/C/F/TAF
Drug: F/R/TAF
Drug: LDV/SOF
Enrollment 150
Recruitment Details Participants were enrolled at study sites in the United States. The first participant was screened on 01 April 2016. The last study visit occurred on 29 September 2017.
Pre-assignment Details 259 participants were screened.
Arm/Group Title E/C/F/TAF + LDV/SOF F/R/TAF + LDV/SOF
Hide Arm/Group Description

Part 1: Participants received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.

Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Part 1: Participants received emtricitabine/rilpivirine/tenofovir alafenamide (F/R/TAF) 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.

Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Period Title: Overall Study
Started 76 74
Completed 72 70
Not Completed 4 4
Reason Not Completed
Death             0             1
Lack of Efficacy             0             1
Investigator's Discretion             1             0
Withdrew Consent             0             1
Lost to Follow-up             1             1
Participants Randomized but Not Treated             2             0
Arm/Group Title E/C/F/TAF + LDV/SOF F/R/TAF + LDV/SOF Total
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Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.

Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.

Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Total of all reporting groups
Overall Number of Baseline Participants 74 74 148
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug (E/C/F/TAF, F/R/TAF, or LDV/SOF).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants 74 participants 148 participants
51  (9.5) 52  (9.9) 51  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
Female
16
  21.6%
22
  29.7%
38
  25.7%
Male
58
  78.4%
52
  70.3%
110
  74.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
Hispanic or Latino
13
  17.6%
14
  18.9%
27
  18.2%
Not Hispanic or Latino
61
  82.4%
59
  79.7%
120
  81.1%
Unknown or Not Reported
0
   0.0%
1
   1.4%
1
   0.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
Asian
1
   1.4%
0
   0.0%
1
   0.7%
Black
30
  40.5%
31
  41.9%
61
  41.2%
White
41
  55.4%
37
  50.0%
78
  52.7%
Native Hawaiian or Pacific Islander
0
   0.0%
2
   2.7%
2
   1.4%
Other
2
   2.7%
3
   4.1%
5
   3.4%
American Indian or Alaska Native
0
   0.0%
1
   1.4%
1
   0.7%
HCV RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
< 800,000 IU/mL
25
  33.8%
14
  18.9%
39
  26.4%
≥ 800,000 IU/mL
49
  66.2%
60
  81.1%
109
  73.6%
HIV-1 RNA Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants 74 participants 148 participants
< 50 copies/mL
73
  98.6%
74
 100.0%
147
  99.3%
≥ 50 copies/mL
1
   1.4%
0
   0.0%
1
   0.7%
HCV RNA  
Mean (Standard Deviation)
Unit of measure:  Log10 IU/mL
Number Analyzed 74 participants 74 participants 148 participants
6.0  (1.07) 6.3  (0.74) 6.2  (0.92)
1.Primary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at 12 Weeks After Discontinuation of LDV/SOF Treatment (SVR12)
Hide Description Sustained Virologic Response (SVR12) was defined as HCV RNA < the lower limit of quantitation (LLOQ) at 12 weeks after stopping LDV/SOF treatment.
Time Frame HCV Posttreatment Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
HCV Full Analysis Set: participants who were randomized into the study and received at least 1 dose of HCV study drug, LDV/SOF.
Arm/Group Title E/C/F/TAF + LDV/SOF F/R/TAF + LDV/SOF
Hide Arm/Group Description:

Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.

Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.

Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Overall Number of Participants Analyzed 72 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.6
(92.5 to 100.0)
95.8
(88.3 to 99.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF + LDV/SOF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.
Method Binomial test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection F/R/TAF + LDV/SOF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.
Method Binomial test
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants With HCV RNA < LLOQ at 4 Weeks After Discontinuation of LDV/SOF Treatment (SVR4)
Hide Description SVR4 was defined as HCV RNA < LLOQ at 4 weeks after stopping LDV/SOF treatment.
Time Frame HCV Posttreatment Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
HCV Full Analysis Set
Arm/Group Title E/C/F/TAF + LDV/SOF F/R/TAF + LDV/SOF
Hide Arm/Group Description:

Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.

Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.

Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Overall Number of Participants Analyzed 72 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
98.6
(92.5 to 100.0)
98.6
(92.5 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF + LDV/SOF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.
Method Binomial test
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection F/R/TAF + LDV/SOF
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments The p-value is obtained from the 2-sided exact 1-sample binomial test for the superiority over the performance goal of 88%.
Method Binomial test
Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL (Virologic Failure) 24 Weeks After Start of the F/TAF-Based Regimen Using Modified FDA Snapshot Algorithm
Hide Description The percentage of participants with HIV-1 RNA ≥ 50 copies/mL 24 weeks after start of the F/TAF-based regimen were analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status.
Time Frame 24 weeks after start of HIV treatment
Hide Outcome Measure Data
Hide Analysis Population Description
HIV Full Analysis Set: participants who were randomized into the study and received at least 1 dose of HIV study drug, E/C/F/TAF or F/R/TAF.
Arm/Group Title E/C/F/TAF + LDV/SOF F/R/TAF + LDV/SOF
Hide Arm/Group Description:

Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.

Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.

Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Overall Number of Participants Analyzed 74 74
Measure Type: Number
Unit of Measure: percentage of participants
1.4 1.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection E/C/F/TAF + LDV/SOF, F/R/TAF + LDV/SOF
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher exact test
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Percentages
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-6.1 to 6.1
Estimation Comments The differences in percentages of participants between treatment groups and their 95% confidence intervals (CIs) were calculated based on an unconditional exact method using 2 inverted 1-sided tests.
4.Secondary Outcome
Title Percentage of Participants Experiencing Grades 1 Through 4 Adverse Events After Switch to E/C/F/TAF or F/R/TAF Throughout the Study and During Coadministeration With LDV/SOF Treatment
Hide Description [Not Specified]
Time Frame Up to 32 weeks plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description

Safety Analysis Set (Whole Study): participants who were randomized into the study and received at least 1 dose of study drug (E/C/F/TAF, F/R/TAF, or LDV/SOF).

Safety Analysis Set (Part 2): participants who entered Part 2 of the study and received at least one dose of study drug LDV/SOF.

Arm/Group Title E/C/F/TAF + LDV/SOF (Co-administration: Week 8 to Week 20) F/R/TAF + LDV/SOF (Co-administration: Week 8 to Week 20) E/C/F/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV Week 12) F/R/TAF + LDV/SOF (Whole Study: Day 1 to Post-HCV to Week 12)
Hide Arm/Group Description:
In Part 2 of the study, participants from part 1 continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).
In Part 2 of the study, participants from part 1 continued receiving (F/R/TAF) 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Part 1: Participants received E/C/F/TAF 150/150/200/10 mg tablet orally once daily with food for 8 weeks.

Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg tablet orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Part 1: Participants received F/R/TAF 200/25/25 mg tablet orally once daily with food for 8 weeks.

Part 2: Participants continued receiving (F/R/TAF) 200/25/25 mg tablet orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Overall Number of Participants Analyzed 72 72 74 74
Measure Type: Number
Unit of Measure: percentage of participants
62.5 69.4 83.8 79.7
Time Frame Up to 32 weeks plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who were randomized into the study and received at least 1 dose of study drug (E/C/F/TAF, F/R/TAF, or LDV/SOF).
 
Arm/Group Title E/C/F/TAF + LDV/SOF F/R/TAF + LDV/SOF
Hide Arm/Group Description

Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.

Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA < 50 copies/mL continued to Part 2 of the study.

Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20).

All-Cause Mortality
E/C/F/TAF + LDV/SOF F/R/TAF + LDV/SOF
Affected / at Risk (%) Affected / at Risk (%)
Total   0/74 (0.00%)   1/74 (1.35%) 
Hide Serious Adverse Events
E/C/F/TAF + LDV/SOF F/R/TAF + LDV/SOF
Affected / at Risk (%) Affected / at Risk (%)
Total   7/74 (9.46%)   12/74 (16.22%) 
Blood and lymphatic system disorders     
Iron deficiency anaemia  1  1/74 (1.35%)  0/74 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/74 (0.00%)  1/74 (1.35%) 
General disorders     
Asthenia  1  0/74 (0.00%)  1/74 (1.35%) 
Chest pain  1  0/74 (0.00%)  1/74 (1.35%) 
Infections and infestations     
Gastroenteritis  1  1/74 (1.35%)  0/74 (0.00%) 
Influenza  1  0/74 (0.00%)  1/74 (1.35%) 
Pneumonia  1  0/74 (0.00%)  2/74 (2.70%) 
Testicular abscess  1  0/74 (0.00%)  1/74 (1.35%) 
Tooth infection  1  1/74 (1.35%)  0/74 (0.00%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/74 (0.00%)  1/74 (1.35%) 
Investigations     
Blood pressure orthostatic abnormal  1  0/74 (0.00%)  1/74 (1.35%) 
Metabolism and nutrition disorders     
Dehydration  1  0/74 (0.00%)  1/74 (1.35%) 
Musculoskeletal and connective tissue disorders     
Flank pain  1  0/74 (0.00%)  1/74 (1.35%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Malignant neoplasm of unknown primary site  1  0/74 (0.00%)  1/74 (1.35%) 
Nervous system disorders     
Headache  1  1/74 (1.35%)  0/74 (0.00%) 
Syncope  1  0/74 (0.00%)  1/74 (1.35%) 
Psychiatric disorders     
Confusional state  1  0/74 (0.00%)  1/74 (1.35%) 
Depression  1  1/74 (1.35%)  0/74 (0.00%) 
Suicidal ideation  1  0/74 (0.00%)  1/74 (1.35%) 
Suicide attempt  1  1/74 (1.35%)  1/74 (1.35%) 
Renal and urinary disorders     
Acute kidney injury  1  0/74 (0.00%)  1/74 (1.35%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  1/74 (1.35%)  0/74 (0.00%) 
Skin and subcutaneous tissue disorders     
Angioedema  1  1/74 (1.35%)  0/74 (0.00%) 
1
Term from vocabulary, MedDRA Version 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
E/C/F/TAF + LDV/SOF F/R/TAF + LDV/SOF
Affected / at Risk (%) Affected / at Risk (%)
Total   46/74 (62.16%)   36/74 (48.65%) 
Gastrointestinal disorders     
Abdominal pain  1  4/74 (5.41%)  3/74 (4.05%) 
Diarrhoea  1  6/74 (8.11%)  3/74 (4.05%) 
Nausea  1  4/74 (5.41%)  6/74 (8.11%) 
General disorders     
Fatigue  1  4/74 (5.41%)  5/74 (6.76%) 
Influenza like illness  1  4/74 (5.41%)  0/74 (0.00%) 
Infections and infestations     
Bronchitis  1  1/74 (1.35%)  4/74 (5.41%) 
Upper respiratory tract infection  1  9/74 (12.16%)  5/74 (6.76%) 
Urinary tract infection  1  10/74 (13.51%)  2/74 (2.70%) 
Metabolism and nutrition disorders     
Vitamin D deficiency  1  5/74 (6.76%)  2/74 (2.70%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/74 (9.46%)  5/74 (6.76%) 
Back pain  1  4/74 (5.41%)  2/74 (2.70%) 
Musculoskeletal pain  1  4/74 (5.41%)  1/74 (1.35%) 
Pain in extremity  1  6/74 (8.11%)  1/74 (1.35%) 
Nervous system disorders     
Headache  1  3/74 (4.05%)  8/74 (10.81%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  6/74 (8.11%)  10/74 (13.51%) 
Vascular disorders     
Hypertension  1  0/74 (0.00%)  5/74 (6.76%) 
1
Term from vocabulary, MedDRA Version 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
Publications of Results:
Ramgopal M, Jain M, Hinestrosa F, Asmuth D, Huhn G, Slim J, et al. HIV-1/HCV Coinfection Treatment with Single-Tablet Antiviral Regimens (CoSTARs): 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) after Randomized Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Rilpivirine/F/TAF (R/F/TAF) [Poster LB-12]. AASLD: The Liver Meeting 2017 20-24 October; Washington DC.
Huhn G, Jain M, Hinestrosa F, Asmuth D, Huhn G, Slim J, et al. HIV-1/HCV Coinfection Treatment with Single-Tablet Antiviral Regimens (CoSTARs): 12 Weeks of Ledipasvir/Sofosbuvir (LDV/SOF) after Randomized Switch to Elvitegravir/Cobicistat/ Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Rilpivirine/F/TAF (R/F/TAF) [Poster PE16/52]. European AIDS Conference 2017 25-27 October; Milan Italy.
Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02707601    
Other Study ID Numbers: GS-US-366-1992
2014-004545-27 ( EudraCT Number )
First Submitted: March 9, 2016
First Posted: March 14, 2016
Results First Submitted: September 12, 2018
Results First Posted: October 9, 2018
Last Update Posted: November 14, 2018