Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02296853
Collaborator
(none)
20
5
2
3.8
4
1
Study Details
Study Description
Brief Summary
The primary objective of this study is to evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and its metabolite tenofovir (TFV) in participants with normal hepatic function and in participants with severe hepatic impairment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
20 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-Label, Parallel-Group, Single Dose Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment
Actual Study Start Date
:
Dec 22, 2014
Actual Primary Completion Date
:
Apr 17, 2015
Actual Study Completion Date
:
Apr 17, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Severe Hepatic Impairment Group Participants with severe hepatic impairment will receive a single oral dose of TAF 25 mg on Day 1. |
Drug: TAF
25 mg tablet administered orally
|
| Active Comparator: Matched Normal Hepatic Function Group Participants with normal hepatic function will receive a single oral dose of TAF 25 mg on Day 1. |
Drug: TAF
25 mg tablet administered orally
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetic (PK) Parameter: AUCinf of Tenofovir Alafenamide (TAF), Its Metabolite Tenofovir (TFV) and Free (Unbound) TAF [Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1]
AUCinf is defined as the concentration of drug extrapolated to infinite time.
- PK Parameter: Cmax of TAF, Its Metabolite TFV and Free (Unbound) TAF [Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1]
Cmax is defined as the maximum concentration of drug.
- PK Parameter: AUClast of TAF, Its Metabolite TFV and Free (Unbound) TAF [Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1]
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Secondary Outcome Measures
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) [Day 1 plus 30 days]
TEAEs are events that meet one of the following criteria: any AEs with onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
- Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities [Day 1 plus 30 days]
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. These were graded as Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening. The most severe graded abnormality from all tests was counted for each participant.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Key Inclusion Criteria:
-
Screening laboratory parameters within defined thresholds
-
Creatinine clearance must be ≥ 60 mL/min
Key Exclusion Criteria:
-
Females who are pregnant or nursing or males who have a pregnant partner
-
Infection with hepatitis B virus (HBV) or HIV
-
History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Miami | Florida | United States | 33014 | |
| 2 | Orlando | Florida | United States | 32809 | |
| 3 | San Antonio | Texas | United States | 78215 | |
| 4 | Munich | Germany | D-81241 | ||
| 5 | Gratton | Auckland | New Zealand | 1142 |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02296853
Other Study ID Numbers:
- GS-US-320-1615
- 2014-004426-18
First Posted:
Nov 20, 2014
Last Update Posted:
Dec 9, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gilead Sciences
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled at study sites in Germany, New Zealand, and the United States. The first participant was screened on 22 December 2014. The last study visit occurred on 17 April 2015. |
|---|---|
| Pre-assignment Detail | 28 participants were screened. |
| Arm/Group Title | Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group |
|---|---|---|
| Arm/Group Description | Participants with severe hepatic impairment received a single oral dose of tenofovir alafenamide (TAF) 25 mg on Day 1. | Participants with normal hepatic function received a single oral dose of TAF 25 mg on Day 1. |
| Period Title: Overall Study | ||
| STARTED | 10 | 10 |
| COMPLETED | 10 | 10 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group | Total |
|---|---|---|---|
| Arm/Group Description | Participants with severe hepatic impairment received a single oral dose of TAF 25 mg on Day 1. | Participants with normal hepatic function received a single oral dose of TAF 25 mg on Day 1. | Total of all reporting groups |
| Overall Participants | 10 | 10 | 20 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
57
(7.3)
|
55
(9.3)
|
56
(8.2)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5
50%
|
5
50%
|
10
50%
|
| Male |
5
50%
|
5
50%
|
10
50%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
3
30%
|
4
40%
|
7
35%
|
| Not Hispanic or Latino |
7
70%
|
6
60%
|
13
65%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
1
10%
|
1
5%
|
| White |
10
100%
|
9
90%
|
19
95%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||
| Germany |
1
10%
|
3
30%
|
4
20%
|
| New Zealand |
2
20%
|
2
20%
|
4
20%
|
| United States |
7
70%
|
5
50%
|
12
60%
|
Outcome Measures
| Title | Pharmacokinetic (PK) Parameter: AUCinf of Tenofovir Alafenamide (TAF), Its Metabolite Tenofovir (TFV) and Free (Unbound) TAF |
|---|---|
| Description | AUCinf is defined as the concentration of drug extrapolated to infinite time. |
| Time Frame | Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the PK Analysis Set (consisted of all enrolled participants who received at least 1 dose of the study drug and had at least 1 non-missing PK concentration data for each respective analyte) with available data were analyzed. |
| Arm/Group Title | Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group |
|---|---|---|
| Arm/Group Description | Participants with severe hepatic impairment received a single oral dose of TAF 25 mg on Day 1. | Participants with normal hepatic function received a single oral dose of TAF 25 mg on Day 1. |
| Measure Participants | 10 | 8 |
| TAF |
120.6
(33.96)
|
228.2
(85.30)
|
| TFV |
219.9
(118.70)
|
304.0
(72.45)
|
| Free (unbound) TAF |
42.8
(11.76)
|
46.5
(17.78)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Severe Hepatic Impairment Group, Matched Normal Hepatic Function Group |
|---|---|---|
| Comments | TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group | |
| Type of Statistical Test | Equivalence | |
| Comments | Sample size calculations were done in Query Advisor 6.0 by using the "Two-group t-test of equal means (equal n's)" module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GLSM ratio percentage |
| Estimated Value | 54.04 | |
| Confidence Interval |
(2-Sided) 90% 41.98 to 69.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | Here, GLSM is geometric least square mean. | |
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Severe Hepatic Impairment Group, Matched Normal Hepatic Function Group |
|---|---|---|
| Comments | TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group | |
| Type of Statistical Test | Equivalence | |
| Comments | Sample size calculations were done in Query Advisor 6.0 by using the "Two-group t-test of equal means (equal n's)" module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GLSM ratio percentage |
| Estimated Value | 63.06 | |
| Confidence Interval |
(2-Sided) 90% 42.90 to 92.70 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Severe Hepatic Impairment Group, Matched Normal Hepatic Function Group |
|---|---|---|
| Comments | Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group | |
| Type of Statistical Test | Equivalence | |
| Comments | Sample size calculations were done in Query Advisor 6.0 by using the "Two-group t-test of equal means (equal n's)" module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GLSM ratio percentage |
| Estimated Value | 94.42 | |
| Confidence Interval |
(2-Sided) 90% 72.48 to 122.99 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | PK Parameter: Cmax of TAF, Its Metabolite TFV and Free (Unbound) TAF |
|---|---|
| Description | Cmax is defined as the maximum concentration of drug. |
| Time Frame | Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the PK Analysis Set were analyzed. |
| Arm/Group Title | Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group |
|---|---|---|
| Arm/Group Description | Participants with severe hepatic impairment received a single oral dose of TAF 25 mg on Day 1. | Participants with normal hepatic function received a single oral dose of TAF 25 mg on Day 1. |
| Measure Participants | 10 | 10 |
| TAF |
79.6
(39.31)
|
176.0
(79.77)
|
| TFV |
7.5
(3.95)
|
7.6
(1.83)
|
| Free (unbound) TAF |
29.9
(17.36)
|
36.2
(18.38)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Severe Hepatic Impairment Group, Matched Normal Hepatic Function Group |
|---|---|---|
| Comments | TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group | |
| Type of Statistical Test | Equivalence | |
| Comments | Sample size calculations were done in Query Advisor 6.0 by using the "Two-group t-test of equal means (equal n's)" module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GLSM ratio percentage |
| Estimated Value | 45.10 | |
| Confidence Interval |
(2-Sided) 90% 31.66 to 64.25 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Severe Hepatic Impairment Group, Matched Normal Hepatic Function Group |
|---|---|---|
| Comments | TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group | |
| Type of Statistical Test | Equivalence | |
| Comments | Sample size calculations were done in Query Advisor 6.0 by using the "Two-group t-test of equal means (equal n's)" module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GLSM ratio percentage |
| Estimated Value | 89.88 | |
| Confidence Interval |
(2-Sided) 90% 64.77 to 124.72 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Severe Hepatic Impairment Group, Matched Normal Hepatic Function Group |
|---|---|---|
| Comments | Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group | |
| Type of Statistical Test | Equivalence | |
| Comments | Sample size calculations were done in Query Advisor 6.0 by using the "Two-group t-test of equal means (equal n's)" module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GLSM ratio percentage |
| Estimated Value | 82.16 | |
| Confidence Interval |
(2-Sided) 90% 56.58 to 119.31 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | PK Parameter: AUClast of TAF, Its Metabolite TFV and Free (Unbound) TAF |
|---|---|
| Description | AUClast is defined as the concentration of drug from time zero to the last observable concentration. |
| Time Frame | Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the PK Analysis Set were analyzed. |
| Arm/Group Title | Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group |
|---|---|---|
| Arm/Group Description | Participants with severe hepatic impairment received a single oral dose of TAF 25 mg on Day 1. | Participants with normal hepatic function received a single oral dose of TAF 25 mg on Day 1. |
| Measure Participants | 10 | 10 |
| TAF |
113.1
(30.85)
|
225.7
(85.09)
|
| TFV |
184.2
(99.86)
|
256.7
(59.91)
|
| Free (unbound) TAF |
41.7
(11.17)
|
46
(17.75)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Severe Hepatic Impairment Group, Matched Normal Hepatic Function Group |
|---|---|---|
| Comments | TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group | |
| Type of Statistical Test | Equivalence | |
| Comments | Sample size calculations were done in Query Advisor 6.0 by using the "Two-group t-test of equal means (equal n's)" module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GLSM ratio percentage |
| Estimated Value | 51.20 | |
| Confidence Interval |
(2-Sided) 90% 40.11 to 65.36 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Severe Hepatic Impairment Group, Matched Normal Hepatic Function Group |
|---|---|---|
| Comments | TFV: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group | |
| Type of Statistical Test | Equivalence | |
| Comments | Sample size calculations were done in Query Advisor 6.0 by using the "Two-group t-test of equal means (equal n's)" module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GLSM ratio percentage |
| Estimated Value | 62.04 | |
| Confidence Interval |
(2-Sided) 90% 41.92 to 91.82 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Severe Hepatic Impairment Group, Matched Normal Hepatic Function Group |
|---|---|---|
| Comments | Free (unbound) TAF: Severe Hepatic Impairment Group vs. Matched Normal Hepatic Function Group | |
| Type of Statistical Test | Equivalence | |
| Comments | Sample size calculations were done in Query Advisor 6.0 by using the "Two-group t-test of equal means (equal n's)" module with α (one-sided) = 0.05, upper equivalence limit = ln(2.0) = 0.691, and expected difference = 0. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | GLSM ratio percentage |
| Estimated Value | 93.28 | |
| Confidence Interval |
(2-Sided) 90% 72.62 to 119.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) |
|---|---|
| Description | TEAEs are events that meet one of the following criteria: any AEs with onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. |
| Time Frame | Day 1 plus 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. |
| Arm/Group Title | Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group |
|---|---|---|
| Arm/Group Description | Participants with severe hepatic impairment received a single oral dose of TAF 25 mg on Day 1. | Participants with normal hepatic function received a single oral dose of TAF 25 mg on Day 1. |
| Measure Participants | 10 | 10 |
| Number [percentage of participants] |
40.0
400%
|
30.0
300%
|
| Title | Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities |
|---|---|
| Description | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. These were graded as Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening. The most severe graded abnormality from all tests was counted for each participant. |
| Time Frame | Day 1 plus 30 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants in the Safety Analysis Set were analyzed. |
| Arm/Group Title | Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group |
|---|---|---|
| Arm/Group Description | Participants with severe hepatic impairment received a single oral dose of TAF 25 mg on Day 1. | Participants with normal hepatic function received a single oral dose of TAF 25 mg on Day 1. |
| Measure Participants | 10 | 10 |
| Grade 1 |
40.0
400%
|
30.0
300%
|
| Grade 2 |
40.0
400%
|
30.0
300%
|
| Grade 3 |
20.0
200%
|
10.0
100%
|
| Grade 4 |
0
0%
|
0
0%
|
Adverse Events
| Time Frame | Day 1 plus 30 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | The Safety Analysis Set included all enrolled participants who received at least 1 dose of study drug. | |||
| Arm/Group Title | Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group | ||
| Arm/Group Description | Participants with severe hepatic impairment received a single oral dose of TAF 25 mg on Day 1. | Participants with normal hepatic function received a single oral dose of TAF 25 mg of on Day 1. | ||
All Cause Mortality |
||||
| Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/10 (0%) | ||
Serious Adverse Events |
||||
| Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/10 (10%) | 0/10 (0%) | ||
| Hepatobiliary disorders | ||||
| Hepatic failure | 1/10 (10%) | 0/10 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Severe Hepatic Impairment Group | Matched Normal Hepatic Function Group | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/10 (40%) | 3/10 (30%) | ||
| Gastrointestinal disorders | ||||
| Abdominal distension | 1/10 (10%) | 0/10 (0%) | ||
| Nausea | 0/10 (0%) | 2/10 (20%) | ||
| Vomiting | 0/10 (0%) | 1/10 (10%) | ||
| General disorders | ||||
| Fatigue | 0/10 (0%) | 1/10 (10%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Musculoskeletal chest pain | 1/10 (10%) | 0/10 (0%) | ||
| Nervous system disorders | ||||
| Headache | 1/10 (10%) | 2/10 (20%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Cough | 1/10 (10%) | 0/10 (0%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Pruritus | 1/10 (10%) | 0/10 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
| Name/Title | Gilead Clinical Study Information Center |
|---|---|
| Organization | Gilead Sciences |
| Phone | 1-833-445-3230 (GILEAD-0) |
| GileadClinicalTrials@gilead.com |
Responsible Party:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02296853
Other Study ID Numbers:
- GS-US-320-1615
- 2014-004426-18
First Posted:
Nov 20, 2014
Last Update Posted:
Dec 9, 2020
Last Verified:
Nov 1, 2020