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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002496-10 | EudraCT Number |
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The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GS-9674 30 mg | Experimental | GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks |
|
| GS-9674 100 mg | Experimental | GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks |
|
| Placebo | Placebo Comparator | Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-9674 | Drug | Tablet administered orally once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as 1 or both of the following: 1) Any adverse events (AE) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug, 2) Any AEs leading to premature discontinuation of study drug. | Up to 24 weeks plus 30 days |
| Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study. | Up to 24 weeks plus 30 days |
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Key Inclusion Criteria:
Meets the following conditions:
Platelet count ≥ 150,000/mm^3
Albumin ≥ 3.3 g/dL
Serum creatinine ≤ upper limit of normal (ULN)
Key Exclusion Criteria:
Pregnant or lactating females
Alanine aminotransferase (ALT) > 5x upper limit of the normal range (ULN)
Other causes of liver disease including autoimmune, viral, and alcoholic liver disease
Cirrhosis of the liver
Body mass index (BMI) < 18 kg/m^2
Uncontrolled diabetes mellitus (hemoglobin A1c > 9% at screening)
International normalized ratio (INR) > 1.2 unless on anticoagulant therapy
Total bilirubin > 1 x ULN, except with diagnosis of Gilbert's syndrome
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruane Clinical Research Group Inc. | Los Angeles | California | 90036 | United States | ||
| Cedars Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32115759 | Derived | Patel K, Harrison SA, Elkhashab M, Trotter JF, Herring R, Rojter SE, Kayali Z, Wong VW, Greenbloom S, Jayakumar S, Shiffman ML, Freilich B, Lawitz EJ, Gane EJ, Harting E, Xu J, Billin AN, Chung C, Djedjos CS, Subramanian GM, Myers RP, Middleton MS, Rinella M, Noureddin M. Cilofexor, a Nonsteroidal FXR Agonist, in Patients With Noncirrhotic NASH: A Phase 2 Randomized Controlled Trial. Hepatology. 2020 Jul;72(1):58-71. doi: 10.1002/hep.31205. |
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327 participants were screened.
Participants were enrolled at study sites in North America, Hong Kong, New Zealand, and Europe. The first participant was screened on 26 October 2016. The last study visit occurred on 09 January 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | GS-9674 100 mg | GS-9674 100 mg tablet once daily + placebo-to-match (PTM) GS-9674 30 mg tablet once daily for 24 weeks. |
| FG001 | GS-9674 30 mg | GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Jun 28, 2016 | Nov 29, 2018 |
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| Placebo to match GS-9674 |
| Drug |
Tablet(s) administered orally once daily |
|
| Los Angeles |
| California |
| 90048 |
| United States |
| Inland Empire Liver Foundation | Rialto | California | 92377 | United States |
| Clinical Research of South Florida | Coral Gables | Florida | 33134 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30308 | United States |
| Northwestern Memorial Hospital, Clinical Research Unit | Chicago | Illinois | 60611 | United States |
| Crescent Clinical Research Center, LLC | Metairie | Louisiana | 70006 | United States |
| Tulane University Health Sciences Center | New Orleans | Louisiana | 70112 | United States |
| Kansas City Research Institute | Kansas City | Missouri | 64131 | United States |
| Concorde Medical Group, PLLC | New York | New York | 10016 | United States |
| Duke University Medical Center, Duke South Clinics | Durham | North Carolina | 27710 | United States |
| Carolinas Center for Liver Disease/Carolinas HealthCare System | Durham | North Carolina | 28078 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Quality Medical Research, PC | Nashville | Tennessee | 37211 | United States |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | United States |
| The Liver Institute at Methodist Dallas Medical Center | Dallas | Texas | 75203 | United States |
| Texas Digestive Disease Consultants | Dallas | Texas | 75246 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Pinnacle Clinical Research | Live Oak | Texas | 78233 | United States |
| American Research Corporation at the Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Intermountain Liver Disease and Transplant Center | Murray | Utah | 84107 | United States |
| Bon Secours St. Mary's Hospital of Richmond, Inc d/b/a Bon Secours Liver Institute of Virginia | Newport News | Virginia | 23602 | United States |
| Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia | Richmond | Virginia | 23226 | United States |
| McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| Swedish Organ Transplant and Liver Center | Seattle | Washington | 98104 | United States |
| University of Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| LMC Clinical Research Inc (Bayview) | Toronto | Ontario | M4G 3E8 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2C4 | Canada |
| Toronto Liver Center | Toronto | Ontario | M6H 3M1 | Canada |
| Toronto Digestive Disease Associates, Inc. | Vaughan | Ontario | L4L 4Y7 | Canada |
| Princess Margaret Hospital | Kowloon | Hong Kong |
| The Chinese University of Hong Kong | Shatin | Hong Kong |
| Auckland Clinical Studies | Auckland | 1010 | New Zealand |
| Universitatsspital Bern, Inselspital, Universitatsklinik fur Viszerale Chirurgie und Medizin, Hepatologie | Bern | 3010 | Switzerland |
| Universitatsspital Zurich | Zurich | CH-8091 | Switzerland |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| FG002 | Placebo | PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks. |
| COMPLETED |
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| NOT COMPLETED |
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Safety Analysis Set included all participants who took at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | GS-9674 100 mg | GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks. |
| BG001 | GS-9674 30 mg | GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks. |
| BG002 | Placebo | PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| 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 | Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | TEAEs were defined as 1 or both of the following: 1) Any adverse events (AE) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug, 2) Any AEs leading to premature discontinuation of study drug. | Safety Analysis Set included all participants who took at least 1 dose of study drug. | Posted | Number | Percentage of participants | Up to 24 weeks plus 30 days |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities | Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study. | Safety Analysis Set | Posted | Number | Percentage of participants | Up to 24 weeks plus 30 days |
|
|
Up to 24 weeks plus 30 days
Safety Analysis Set included all participants who took at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GS-9674 100 mg | GS-9674 100 mg tablet once daily + PTM GS-9674 30 mg tablet once daily for 24 weeks. | 0 | 56 | 2 | 56 | 39 | 56 |
| EG001 | GS-9674 30 mg | GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks. | 0 | 56 | 2 | 56 | 34 | 56 |
| EG002 | Placebo | PTM GS-9674 30 mg tablet once daily + PTM GS-9674 100 mg tablet once daily for 24 weeks. | 0 | 28 | 1 | 28 | 17 | 28 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bile duct stone | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
| |
| B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypertensive crisis | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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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:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Oct 3, 2016 | Nov 29, 2018 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Jan 24, 2017 | Nov 29, 2018 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2017 | Nov 29, 2018 | SAP_003.pdf |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| Other |
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| Canada |
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| Hong Kong |
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| United States |
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| United Kingdom |
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| Switzerland |
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