Study to Evaluate the Safety, Tolerability, and Efficacy... | NCT02943447 | Trialant
NCT02943447
Sponsor
Gilead Sciences
Status
Terminated
Last Update Posted
Sep 22, 2020Actual
Enrollment
71Actual
Phase
Phase 2
Conditions
Primary Biliary Cholangitis
Interventions
Cilofexor
Placebo to match cilofexor
Countries
United States
Austria
Canada
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02943447
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
GS-US-427-4024
Secondary IDs
ID
Type
Description
Link
2016-002443-42
EudraCT Number
Brief Title
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis
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
Acronym
PBC-Phase 2
Organization
Gilead SciencesINDUSTRY
Status Module
Record Verification Date
Sep 2020
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
The study was terminated because of the availability of alternate therapies for primary biliary cholangitis (PBC).
Expanded Access Info
No
Start Date
Dec 1, 2016Actual
Primary Completion Date
Sep 4, 2019Actual
Completion Date
Sep 4, 2019Actual
First Submitted Date
Jun 13, 2016
First Submission Date that Met QC Criteria
Oct 21, 2016
First Posted Date
Oct 24, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 19, 2019
Results First Submitted that Met QC Criteria
Dec 19, 2019
Results First Posted Date
Jan 13, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 3, 2019
Certification/Extension First Submitted that Passed QC Review
Jun 3, 2019
Certification/Extension First Posted Date
Jun 5, 2019Actual
Last Update Submitted Date
Sep 3, 2020
Last Update Posted Date
Sep 22, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Gilead SciencesINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary biliary cholangitis (PBC).
Detailed Description
Not provided
Conditions Module
Conditions
Primary Biliary Cholangitis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
71Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cilofexor 30 mg (Blinded Study Phase)
Experimental
Cilofexor 30 mg + placebo to match cilofexor 100 mg for 12 weeks.
Drug: Cilofexor
Drug: Placebo to match cilofexor
Cilofexor 100 mg (Blinded Study Phase)
Experimental
Cilofexor 100 mg + placebo to match cilofexor 30 mg for 12 weeks.
Drug: Cilofexor
Drug: Placebo to match cilofexor
Placebo (Blinded Study Phase)
Placebo Comparator
Placebo to match cilofexor 30 mg + placebo to match cilofexor 100 mg for 12 weeks.
Drug: Placebo to match cilofexor
Cilofexor (Open Label Extension Phase)
Experimental
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
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Cilofexor
Drug
Tablet(s) administered orally once daily, with food
Cilofexor (Open Label Extension Phase)
Cilofexor 100 mg (Blinded Study Phase)
Cilofexor 30 mg (Blinded Study Phase)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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
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
Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the Blinded Study Phase
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.
First dose date up to Week 12 + 30 days
Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the OLE Phase
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.
First dose date in the OLE phase up to last dose date (Maximum: 97.4 weeks) + 30 days
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
70 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Gilead Study Director
Gilead Sciences
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Sacramento
California
95817
United States
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Result
Kowdley KV, Minuk GY, Pagadala MR, Gulamhusein A, Swain MG, Neff GW, et al. The Nonsteroidal Farnesoid X Receptor (FXR) Agonist Cilofexor Improves Liver Biochemistry in Patients with Primary Biliary Cholangitis (PBC): A Phase 2, Randomized, Placebo-Controlled Trial [Abstract 45]. Hepatology AASLD Abstracts 2019;70 (Suppl 1):31A-2A.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
130 participants were screened.
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cilofexor 100 mg
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.
FG001
Periods
Title
Milestones
Reasons Not Completed
Blinded Study Phase
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Feb 9, 2017
Nov 27, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
GS-9674
Placebo to match cilofexor
Drug
Tablet(s) administered orally once daily, with food
Cilofexor 100 mg (Blinded Study Phase)
Cilofexor 30 mg (Blinded Study Phase)
Placebo (Blinded Study Phase)
Aurora
Colorado
80045
United States
Lakewood Rch
Florida
34211
United States
Miami
Florida
33136
United States
Marietta
Georgia
30060
United States
Saint Paul
Minnesota
55114
United States
Arlington
Texas
76012
United States
Dallas
Texas
75203
United States
Dallas
Texas
75246
United States
Houston
Texas
77030
United States
Charlottesville
Virginia
22908
United States
Newport News
Virginia
23602
United States
Seattle
Washington
98104
United States
Vienna
State of Vienna
1090
Austria
Graz
Styria
8036
Austria
Calgary
Alberta
T2N 4Z6
Canada
Vancouver
British Columbia
V5Z 1M9
Canada
Vancouver
British Columbia
V6Z 2K5
Canada
Winnipeg
Manitoba
R3E 0T6
Canada
Toronto
Ontario
M5G 2C4
Canada
Vaughan
Ontario
L4L 4Y7
Canada
Birmingham
England
B215 2GW
United Kingdom
London
England
NW3 2QG
United Kingdom
London
England
SE5 9RS
United Kingdom
Norwich
England
NR4 7UY
United Kingdom
Cilofexor 30 mg
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.
FG002
Placebo
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.
FG00028 subjects
FG00130 subjects
FG00213 subjects
COMPLETED
FG00023 subjects
FG00128 subjects
FG00212 subjects
NOT COMPLETED
FG0005 subjects
FG0012 subjects
FG0021 subjects
Type
Comment
Reasons
Withdrew Consent
FG0001 subjects
FG0012 subjects
FG0021 subjects
Adverse Event
FG0003 subjects
FG0010 subjects
FG0020 subjects
Investigator's discretion
FG0001 subjects
FG0010 subjects
FG0020 subjects
Open-Label Extension Phase
Type
Comment
Milestone Data
STARTED
FG00023 subjects
FG00128 subjects
FG00212 subjects
COMPLETED
FG0005 subjects
FG0013 subjects
FG0022 subjects
NOT COMPLETED
FG00018 subjects
FG00125 subjects
FG00210 subjects
Type
Comment
Reasons
Study terminated by sponsor
FG00010 subjects
FG00112 subjects
FG0026 subjects
Adverse Event
FG000
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cilofexor 100 mg
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.
BG001
Cilofexor 30 mg
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.
BG002
Placebo
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.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00028
BG00130
BG00213
BG00371
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00054± 9.8
BG00157± 6.3
BG00258± 5.9
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00028
BG00126
BG002
Race/Ethnicity, Customized
Not Permitted = local regulators did not allow collection of race information.
Count of Participants
Participants
No
Title
Denominators
Categories
Race
Title
Measurements
Asian
BG0002
BG0010
BG002
Race/Ethnicity, Customized
Not Permitted = local regulators did not allow collection of ethnicity information.
Count of Participants
Participants
No
Title
Denominators
Categories
Ethnicity
Title
Measurements
Hispanic or Latino
BG0001
BG0011
Region of Enrollment
Number
participants
Title
Denominators
Categories
Canada
Title
Measurements
BG0009
BG0019
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) in the Blinded Study Phase
The Safety Analysis Set included all participants who took at least 1 dose of study drug.
Posted
Number
percentage of participants
First dose date up to Week 12 + 30 days
ID
Title
Description
OG000
Blinded Study Phase: Cilofexor 100 mg
Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
OG001
Blinded Study Phase: Cilofexor 30 mg
Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
OG002
Blinded Study Phase: Placebo
Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
Units
Counts
Participants
OG00028
OG00130
OG00213
Title
Denominators
Categories
TEAEs
Title
Measurements
OG00089.3
OG00176.7
OG00284.6
TESAEs
Primary
Percentage of Participants Experiencing TEAEs and TESAEs in the Open-Label Extension (OLE) Phase
The OLE Analysis Set included all participants who took at least 1 dose of study drug in the OLE Phase.
Posted
Number
percentage of participants
First dose date in the OLE phase up to last dose date (Maximum: 97.4 weeks) + 30 days
ID
Title
Description
OG000
OLE Phase: From Cilofexor 100 mg
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.
OG001
OLE Phase: From Cilofexor 30 mg
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.
OG002
OLE Phase: From Placebo
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.
Units
Counts
Primary
Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the Blinded Study Phase
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.
Participants in the Safety Analysis Set were analyzed.
Posted
Number
percentage of participants
First dose date up to Week 12 + 30 days
ID
Title
Description
OG000
Blinded Study Phase: Cilofexor 100 mg
Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
OG001
Blinded Study Phase: Cilofexor 30 mg
Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
OG002
Blinded Study Phase: Placebo
Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
Primary
Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the OLE Phase
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.
Participants in the OLE Analysis Set were analyzed.
Posted
Number
percentage of participants
First dose date in the OLE phase up to last dose date (Maximum: 97.4 weeks) + 30 days
ID
Title
Description
OG000
OLE Phase: From Cilofexor 100 mg
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.
OG001
OLE Phase: From Cilofexor 30 mg
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.
OG002
OLE Phase: From Placebo
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.
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
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Blinded Study Phase: Cilofexor 100 mg
Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
0
28
0
28
21
28
EG001
Blinded Study Phase: Cilofexor 30 mg
Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
0
30
1
30
18
30
EG002
Blinded Study Phase: Placebo
Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
0
13
0
13
11
13
EG003
OLE Phase: From Cilofexor 100 mg
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.
0
23
1
23
20
23
EG004
OLE Phase: From Cilofexor 30 mg
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.
0
28
0
28
25
28
EG005
OLE Phase: From Placebo
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.
0
12
0
12
12
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Appendicitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected13 at risk
EG0030 affected23 at risk
EG0040 affected28 at risk
EG0050 affected12 at risk
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Vertigo
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected30 at risk
EG0020 affected13 at risk
EG0032 affected23 at risk
EG0040 affected28 at risk
EG0050 affected12 at risk
Dry eye
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Eye pruritus
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected13 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0012 affected30 at risk
EG0020 affected13 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected13 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected28 at risk
EG0012 affected30 at risk
EG0021 affected13 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected28 at risk
EG0011 affected30 at risk
EG0020 affected13 at risk
EG003
Barrett's oesophagus
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected30 at risk
EG0022 affected13 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected28 at risk
EG0014 affected30 at risk
EG0021 affected13 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Gingival bleeding
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected13 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0003 affected28 at risk
EG0012 affected30 at risk
EG0023 affected13 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0002 affected28 at risk
EG0011 affected30 at risk
EG0020 affected13 at risk
EG003
Cyst
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Fatigue
General disorders
MedDRA 22.0
Systematic Assessment
EG0005 affected28 at risk
EG0012 affected30 at risk
EG0023 affected13 at risk
EG003
Influenza like illness
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Peripheral swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Pyrexia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0021 affected13 at risk
EG003
Suprapubic pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Abscess neck
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected13 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Carbuncle
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected13 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Infected skin ulcer
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0004 affected28 at risk
EG0015 affected30 at risk
EG0021 affected13 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected13 at risk
EG003
Skin infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected13 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 affected28 at risk
EG0012 affected30 at risk
EG0020 affected13 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected13 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Procedural anxiety
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Blood cholesterol increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Bone pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected13 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected13 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected13 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected28 at risk
EG0014 affected30 at risk
EG0024 affected13 at risk
EG003
Hyperaesthesia
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected13 at risk
EG003
Somnolence
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0021 affected13 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected13 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected13 at risk
EG003
Personality change
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected13 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG00013 affected28 at risk
EG0016 affected30 at risk
EG0023 affected13 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0004 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Rash maculo-papular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0021 affected13 at risk
EG003
Flushing
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0010 affected30 at risk
EG0020 affected13 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 affected28 at risk
EG0011 affected30 at risk
EG0020 affected13 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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