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PBC-Phase 2: Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis

Sponsor
Gilead Sciences (Industry)
Overall Status
Terminated
CT.gov ID
NCT02943447
Collaborator
(none)
71
Enrollment
25
Locations
4
Arms
33.1
Actual Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary biliary cholangitis (PBC).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
71 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Primary Biliary Cholangitis Without Cirrhosis
Actual Study Start Date :
Dec 1, 2016
Actual Primary Completion Date :
Sep 4, 2019
Actual Study Completion Date :
Sep 4, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cilofexor 30 mg (Blinded Study Phase)

Cilofexor 30 mg + placebo to match cilofexor 100 mg for 12 weeks.

Drug: Cilofexor
Tablet(s) administered orally once daily, with food
Other Names:
  • GS-9674

    • Drug: Placebo to match cilofexor
    Tablet(s) administered orally once daily, with food
    Experimental: Cilofexor 100 mg (Blinded Study Phase)

    Cilofexor 100 mg + placebo to match cilofexor 30 mg for 12 weeks.

    Drug: Cilofexor
    Tablet(s) administered orally once daily, with food
    Other Names:
  • GS-9674

    • Drug: Placebo to match cilofexor
    Tablet(s) administered orally once daily, with food
    Placebo Comparator: Placebo (Blinded Study Phase)

    Placebo to match cilofexor 30 mg + placebo to match cilofexor 100 mg for 12 weeks.

    Drug: Placebo to match cilofexor
    Tablet(s) administered orally once daily, with food
    Experimental: Cilofexor (Open Label Extension Phase)

    Following the Blinded Study Phase, eligible participants may have the option to receive open-label cilofexor 100 mg for an additional 96 weeks.

    Drug: Cilofexor
    Tablet(s) administered orally once daily, with food
    Other Names:
  • GS-9674

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) in the Blinded Study Phase [First dose date up to Week 12 + 30 days]

    2. Percentage of Participants Experiencing TEAEs and TESAEs in the Open-Label Extension (OLE) Phase [First dose date in the OLE phase up to last dose date (Maximum: 97.4 weeks) + 30 days]

    3. Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the Blinded Study Phase [First dose date up to Week 12 + 30 days]

      Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.

    4. Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the OLE Phase [First dose date in the OLE phase up to last dose date (Maximum: 97.4 weeks) + 30 days]

      Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. 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:
    No
    Key Inclusion Criteria:

    • Meets all of the following conditions

    • Definite or probable PBC as defined by at least 2 of the 3 following criteria:

    • Serum alkaline phosphatase (ALP) > the upper limit of normal (ULN)

    • Presence of anti-mitochondrial antibodies (AMA) in serum (≥ 1:40 on immunofluorescence)

    • Liver histological findings consistent with PBC including nonsuppurative, destructive cholangitis affecting mainly the interlobular bile and septal bile ducts

    • Serum ALP > 1.67 x ULN and/or total bilirubin >ULN but ≤ 2 x ULN

    • Ursodeoxycholic acid (UDCA) use at a stable dose for at least 12 months or intolerant of UDCA with no UDCA use for at least 12 months before screening

    • Screening FibroSURE/FibroTest® < 0.75 unless a historical liver biopsy within 12 months of screening does not reveal cirrhosis. In adults with Gilbert's syndrome or hemolysis, FibroSURE/FibroTest will be calculated using direct bilirubin instead of total bilirubin.

    Key Exclusion Criteria:

    • Alanine aminotransferase (ALT) > 5 x ULN

    • Total bilirubin > 2 x ULN

    • International normalized ratio (INR) > 1.2 unless on anticoagulant therapy

    • Other causes of liver disease including viral, metabolic, alcoholic, and other autoimmune conditions. Participants with hepatic steatosis may be included if there is no evidence of nonalcoholic steatohepatitis (NASH) in the opinion of the investigator or on liver biopsy.

    • Use of fibrates or obeticholic acid within 3 months prior to screening through the end of treatment

    • Cirrhosis of the liver as defined by any of the following:

    • Historical liver biopsy demonstrating cirrhosis (eg, Ludwig stage 4 or Ishak stage ≥ 5)

    • History of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding

    • Liver stiffness > 16.9 kPa by FibroScan®

    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sacramento California United States 95817
    2 Aurora Colorado United States 80045
    3 Lakewood Ranch Florida United States 34211
    4 Miami Florida United States 33136
    5 Marietta Georgia United States 30060
    6 Saint Paul Minnesota United States 55114
    7 Arlington Texas United States 76012
    8 Dallas Texas United States 75203
    9 Dallas Texas United States 75246
    10 Houston Texas United States 77030
    11 Charlottesville Virginia United States 22908
    12 Newport News Virginia United States 23602
    13 Seattle Washington United States 98104
    14 Graz Steiermark Austria 8036
    15 Wien Vienna Austria 1090
    16 Calgary Alberta Canada T2N 4Z6
    17 Vancouver British Columbia Canada V5Z 1M9
    18 Vancouver British Columbia Canada V6Z 2K5
    19 Winnipeg Manitoba Canada R3E 0T6
    20 Toronto Ontario Canada M5G 2C4
    21 Vaughan Ontario Canada L4L 4Y7
    22 Birmingham England United Kingdom B215 2GW
    23 London England United Kingdom NW3 2QG
    24 London England United Kingdom SE5 9RS
    25 Norwich England United Kingdom NR4 7UY

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Gilead Study Director, Gilead Sciences

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02943447
    Other Study ID Numbers:
    • GS-US-427-4024
    • 2016-002443-42
    First Posted:
    Oct 24, 2016
    Last Update Posted:
    Sep 22, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cholangitis
    Liver Cirrhosis, Biliary

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in United States, Canada, United Kingdom, and Austria. The first participant was screened on 01 December 2016. The last study visit occurred on 4 September 2019.
    Pre-assignment Detail 130 participants were screened.
    Arm/Group Title Cilofexor 100 mg Cilofexor 30 mg Placebo
    Arm/Group Description Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks. Open-Label Extension (OLE) Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks. Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks. OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks. Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks. OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks.
    Period Title: Blinded Study Phase
    STARTED 28 30 13
    COMPLETED 23 28 12
    NOT COMPLETED 5 2 1
    Period Title: Blinded Study Phase
    STARTED 23 28 12
    COMPLETED 5 3 2
    NOT COMPLETED 18 25 10

    Baseline Characteristics

    Arm/Group Title Cilofexor 100 mg Cilofexor 30 mg Placebo Total
    Arm/Group Description Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks. Open Label Extension (OLE) Phase: Following Blinded Study Phase, participants willing to enter OLE phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks. Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks. OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks. Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks. OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks. Total of all reporting groups
    Overall Participants 28 30 13 71
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    54
    (9.8)
    57
    (6.3)
    58
    (5.9)
    56
    (7.9)
    Sex: Female, Male (Count of Participants)
    Female
    28
    100%
    26
    86.7%
    12
    92.3%
    66
    93%
    Male
    0
    0%
    4
    13.3%
    1
    7.7%
    5
    7%
    Race/Ethnicity, Customized (Count of Participants)
    Asian
    2
    7.1%
    0
    0%
    0
    0%
    2
    2.8%
    Black or African American
    0
    0%
    1
    3.3%
    0
    0%
    1
    1.4%
    White
    26
    92.9%
    27
    90%
    13
    100%
    66
    93%
    Not Permitted
    0
    0%
    1
    3.3%
    0
    0%
    1
    1.4%
    Other
    0
    0%
    1
    3.3%
    0
    0%
    1
    1.4%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    1
    3.6%
    1
    3.3%
    2
    15.4%
    4
    5.6%
    Not Hispanic or Latino
    26
    92.9%
    28
    93.3%
    11
    84.6%
    65
    91.5%
    Not Permitted
    1
    3.6%
    1
    3.3%
    0
    0%
    2
    2.8%
    Region of Enrollment (participants) [Number]
    Canada
    9
    32.1%
    9
    30%
    3
    23.1%
    21
    29.6%
    Austria
    4
    14.3%
    2
    6.7%
    1
    7.7%
    7
    9.9%
    United States
    12
    42.9%
    16
    53.3%
    7
    53.8%
    35
    49.3%
    United Kingdom
    3
    10.7%
    3
    10%
    2
    15.4%
    8
    11.3%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) in the Blinded Study Phase
    Description
    Time Frame First dose date up to Week 12 + 30 days

    Outcome Measure Data

    Analysis Population Description
    The Safety Analysis Set included all participants who took at least 1 dose of study drug.
    Arm/Group Title Blinded Study Phase: Cilofexor 100 mg Blinded Study Phase: Cilofexor 30 mg Blinded Study Phase: Placebo
    Arm/Group Description Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks. Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks. Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
    Measure Participants 28 30 13
    TEAEs
    89.3
    318.9%
    76.7
    255.7%
    84.6
    650.8%
    TESAEs
    0
    0%
    3.3
    11%
    0
    0%
    2. Primary Outcome
    Title Percentage of Participants Experiencing TEAEs and TESAEs in the Open-Label Extension (OLE) Phase
    Description
    Time Frame First dose date in the OLE phase up to last dose date (Maximum: 97.4 weeks) + 30 days

    Outcome Measure Data

    Analysis Population Description
    The OLE Analysis Set included all participants who took at least 1 dose of study drug in the OLE Phase.
    Arm/Group Title OLE Phase: From Cilofexor 100 mg OLE Phase: From Cilofexor 30 mg OLE Phase: From Placebo
    Arm/Group Description OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks. OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks. OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks.
    Measure Participants 23 28 12
    TEAEs
    95.7
    341.8%
    89.3
    297.7%
    100.0
    769.2%
    TESAEs
    4.3
    15.4%
    0
    0%
    0
    0%
    3. Primary Outcome
    Title Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the Blinded Study Phase
    Description Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
    Time Frame First dose date up to Week 12 + 30 days

    Outcome Measure Data

    Analysis Population Description
    Participants in the Safety Analysis Set were analyzed.
    Arm/Group Title Blinded Study Phase: Cilofexor 100 mg Blinded Study Phase: Cilofexor 30 mg Blinded Study Phase: Placebo
    Arm/Group Description Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks. Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks. Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
    Measure Participants 28 30 13
    Any Graded Laboratory Abnormality
    85.7
    306.1%
    86.7
    289%
    92.3
    710%
    Grade 4 or above Laboratory Abnormalities
    0
    0%
    3.3
    11%
    0
    0%
    4. Primary Outcome
    Title Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the OLE Phase
    Description Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
    Time Frame First dose date in the OLE phase up to last dose date (Maximum: 97.4 weeks) + 30 days

    Outcome Measure Data

    Analysis Population Description
    Participants in the OLE Analysis Set were analyzed.
    Arm/Group Title OLE Phase: From Cilofexor 100 mg OLE Phase: From Cilofexor 30 mg OLE Phase: From Placebo
    Arm/Group Description OLE Phase: Following Blinded Study Phase, participants in cilofexor 100 mg group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks. OLE Phase: Following Blinded Study Phase, participants in cilofexor 30 mg group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks. OLE Phase: Following Blinded Study Phase, participants in placebo group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks.
    Measure Participants 23 28 12
    Any Graded Laboratory Abnormality
    91.3
    326.1%
    96.4
    321.3%
    100.0
    769.2%
    Grade 4 or above Laboratory Abnormalities
    0
    0%
    0
    0%
    0
    0%

    Adverse Events

    Time Frame Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
    Adverse Event Reporting Description The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
    Arm/Group Title Blinded Study Phase: Cilofexor 100 mg Blinded Study Phase: Cilofexor 30 mg Blinded Study Phase: Placebo OLE Phase: From Cilofexor 100 mg OLE Phase: From Cilofexor 30 mg OLE Phase: From Placebo
    Arm/Group Description Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks. Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks. Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks. OLE Phase: Following Blinded Study Phase, participants in the Cilofexor 100 mg group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks. OLE Phase: Following Blinded Study Phase, participants in the Cilofexor 30 mg group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks. OLE Phase: Following Blinded Study Phase, participants in the Placebo group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks.
    All Cause Mortality
    Blinded Study Phase: Cilofexor 100 mg Blinded Study Phase: Cilofexor 30 mg Blinded Study Phase: Placebo OLE Phase: From Cilofexor 100 mg OLE Phase: From Cilofexor 30 mg OLE Phase: From Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 0/12 (0%)
    Serious Adverse Events
    Blinded Study Phase: Cilofexor 100 mg Blinded Study Phase: Cilofexor 30 mg Blinded Study Phase: Placebo OLE Phase: From Cilofexor 100 mg OLE Phase: From Cilofexor 30 mg OLE Phase: From Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/28 (0%) 1/30 (3.3%) 0/13 (0%) 1/23 (4.3%) 0/28 (0%) 0/12 (0%)
    Infections and infestations
    Appendicitis 0/28 (0%) 1/30 (3.3%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 0/12 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Invasive ductal breast carcinoma 0/28 (0%) 0/30 (0%) 0/13 (0%) 1/23 (4.3%) 0/28 (0%) 0/12 (0%)
    Other (Not Including Serious) Adverse Events
    Blinded Study Phase: Cilofexor 100 mg Blinded Study Phase: Cilofexor 30 mg Blinded Study Phase: Placebo OLE Phase: From Cilofexor 100 mg OLE Phase: From Cilofexor 30 mg OLE Phase: From Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 21/28 (75%) 18/30 (60%) 11/13 (84.6%) 20/23 (87%) 25/28 (89.3%) 12/12 (100%)
    Ear and labyrinth disorders
    Vertigo 0/28 (0%) 2/30 (6.7%) 0/13 (0%) 2/23 (8.7%) 0/28 (0%) 0/12 (0%)
    Eye disorders
    Dry eye 2/28 (7.1%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 2/28 (7.1%) 1/12 (8.3%)
    Eye pruritus 0/28 (0%) 0/30 (0%) 1/13 (7.7%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Gastrointestinal disorders
    Abdominal discomfort 0/28 (0%) 2/30 (6.7%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 0/12 (0%)
    Abdominal distension 0/28 (0%) 1/30 (3.3%) 0/13 (0%) 0/23 (0%) 2/28 (7.1%) 0/12 (0%)
    Abdominal pain 1/28 (3.6%) 2/30 (6.7%) 1/13 (7.7%) 1/23 (4.3%) 3/28 (10.7%) 1/12 (8.3%)
    Abdominal pain upper 1/28 (3.6%) 1/30 (3.3%) 0/13 (0%) 1/23 (4.3%) 0/28 (0%) 1/12 (8.3%)
    Barrett's oesophagus 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Constipation 2/28 (7.1%) 1/30 (3.3%) 2/13 (15.4%) 2/23 (8.7%) 0/28 (0%) 2/12 (16.7%)
    Diarrhoea 4/28 (14.3%) 4/30 (13.3%) 1/13 (7.7%) 1/23 (4.3%) 6/28 (21.4%) 4/12 (33.3%)
    Dry mouth 1/28 (3.6%) 0/30 (0%) 0/13 (0%) 1/23 (4.3%) 2/28 (7.1%) 0/12 (0%)
    Dyspepsia 3/28 (10.7%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 0/12 (0%)
    Gastrooesophageal reflux disease 1/28 (3.6%) 0/30 (0%) 0/13 (0%) 1/23 (4.3%) 0/28 (0%) 2/12 (16.7%)
    Gingival bleeding 0/28 (0%) 0/30 (0%) 1/13 (7.7%) 0/23 (0%) 0/28 (0%) 0/12 (0%)
    Nausea 3/28 (10.7%) 2/30 (6.7%) 3/13 (23.1%) 3/23 (13%) 2/28 (7.1%) 2/12 (16.7%)
    Vomiting 2/28 (7.1%) 1/30 (3.3%) 0/13 (0%) 1/23 (4.3%) 1/28 (3.6%) 1/12 (8.3%)
    General disorders
    Cyst 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Fatigue 5/28 (17.9%) 2/30 (6.7%) 3/13 (23.1%) 3/23 (13%) 4/28 (14.3%) 2/12 (16.7%)
    Influenza like illness 0/28 (0%) 0/30 (0%) 0/13 (0%) 2/23 (8.7%) 0/28 (0%) 0/12 (0%)
    Peripheral swelling 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 2/28 (7.1%) 0/12 (0%)
    Pyrexia 0/28 (0%) 1/30 (3.3%) 1/13 (7.7%) 0/23 (0%) 1/28 (3.6%) 0/12 (0%)
    Suprapubic pain 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Immune system disorders
    Seasonal allergy 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Infections and infestations
    Abscess neck 0/28 (0%) 0/30 (0%) 1/13 (7.7%) 0/23 (0%) 0/28 (0%) 0/12 (0%)
    Bronchitis 0/28 (0%) 0/30 (0%) 0/13 (0%) 2/23 (8.7%) 0/28 (0%) 1/12 (8.3%)
    Carbuncle 0/28 (0%) 0/30 (0%) 1/13 (7.7%) 0/23 (0%) 0/28 (0%) 0/12 (0%)
    Conjunctivitis 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Infected skin ulcer 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Influenza 2/28 (7.1%) 0/30 (0%) 0/13 (0%) 1/23 (4.3%) 0/28 (0%) 2/12 (16.7%)
    Nasopharyngitis 4/28 (14.3%) 5/30 (16.7%) 1/13 (7.7%) 3/23 (13%) 4/28 (14.3%) 1/12 (8.3%)
    Oral candidiasis 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Sinusitis 0/28 (0%) 1/30 (3.3%) 0/13 (0%) 1/23 (4.3%) 1/28 (3.6%) 1/12 (8.3%)
    Skin infection 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Upper respiratory tract infection 0/28 (0%) 1/30 (3.3%) 0/13 (0%) 1/23 (4.3%) 1/28 (3.6%) 1/12 (8.3%)
    Urinary tract infection 2/28 (7.1%) 2/30 (6.7%) 0/13 (0%) 2/23 (8.7%) 2/28 (7.1%) 2/12 (16.7%)
    Injury, poisoning and procedural complications
    Contusion 0/28 (0%) 0/30 (0%) 0/13 (0%) 1/23 (4.3%) 0/28 (0%) 1/12 (8.3%)
    Joint injury 0/28 (0%) 0/30 (0%) 1/13 (7.7%) 0/23 (0%) 0/28 (0%) 0/12 (0%)
    Limb injury 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Procedural anxiety 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Investigations
    Blood alkaline phosphatase increased 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 1/28 (3.6%) 1/12 (8.3%)
    Blood cholesterol increased 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/28 (0%) 0/30 (0%) 0/13 (0%) 1/23 (4.3%) 3/28 (10.7%) 2/12 (16.7%)
    Back pain 0/28 (0%) 0/30 (0%) 0/13 (0%) 3/23 (13%) 0/28 (0%) 0/12 (0%)
    Bone pain 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 2/12 (16.7%)
    Musculoskeletal pain 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 2/12 (16.7%)
    Myalgia 0/28 (0%) 1/30 (3.3%) 0/13 (0%) 3/23 (13%) 2/28 (7.1%) 1/12 (8.3%)
    Neck pain 0/28 (0%) 0/30 (0%) 1/13 (7.7%) 0/23 (0%) 1/28 (3.6%) 0/12 (0%)
    Pain in extremity 0/28 (0%) 1/30 (3.3%) 0/13 (0%) 2/23 (8.7%) 3/28 (10.7%) 1/12 (8.3%)
    Nervous system disorders
    Headache 4/28 (14.3%) 4/30 (13.3%) 4/13 (30.8%) 2/23 (8.7%) 1/28 (3.6%) 0/12 (0%)
    Hyperaesthesia 0/28 (0%) 0/30 (0%) 1/13 (7.7%) 0/23 (0%) 0/28 (0%) 0/12 (0%)
    Somnolence 0/28 (0%) 1/30 (3.3%) 1/13 (7.7%) 0/23 (0%) 0/28 (0%) 0/12 (0%)
    Tension headache 0/28 (0%) 0/30 (0%) 1/13 (7.7%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Psychiatric disorders
    Insomnia 0/28 (0%) 0/30 (0%) 1/13 (7.7%) 1/23 (4.3%) 2/28 (7.1%) 0/12 (0%)
    Personality change 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain 0/28 (0%) 0/30 (0%) 0/13 (0%) 2/23 (8.7%) 2/28 (7.1%) 0/12 (0%)
    Rhinorrhoea 0/28 (0%) 1/30 (3.3%) 0/13 (0%) 2/23 (8.7%) 0/28 (0%) 0/12 (0%)
    Skin and subcutaneous tissue disorders
    Pruritus 13/28 (46.4%) 6/30 (20%) 3/13 (23.1%) 4/23 (17.4%) 11/28 (39.3%) 6/12 (50%)
    Pruritus generalised 4/28 (14.3%) 0/30 (0%) 0/13 (0%) 1/23 (4.3%) 1/28 (3.6%) 0/12 (0%)
    Rash 0/28 (0%) 0/30 (0%) 0/13 (0%) 2/23 (8.7%) 2/28 (7.1%) 0/12 (0%)
    Rash maculo-papular 1/28 (3.6%) 0/30 (0%) 0/13 (0%) 1/23 (4.3%) 0/28 (0%) 1/12 (8.3%)
    Rash papular 0/28 (0%) 0/30 (0%) 1/13 (7.7%) 0/23 (0%) 0/28 (0%) 0/12 (0%)
    Vascular disorders
    Flushing 0/28 (0%) 0/30 (0%) 0/13 (0%) 0/23 (0%) 0/28 (0%) 1/12 (8.3%)
    Hypertension 0/28 (0%) 1/30 (3.3%) 0/13 (0%) 2/23 (8.7%) 0/28 (0%) 1/12 (8.3%)

    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)
    Email GileadClinicalTrials@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02943447
    Other Study ID Numbers:
    • GS-US-427-4024
    • 2016-002443-42
    First Posted:
    Oct 24, 2016
    Last Update Posted:
    Sep 22, 2020
    Last Verified:
    Sep 1, 2020