Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03890120
Registration number
NCT03890120
Ethics application status
Date submitted
25/03/2019
Date registered
26/03/2019
Date last updated
29/11/2023
Titles & IDs
Public title
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
Query!
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects With Primary Sclerosing Cholangitis
Query!
Secondary ID [1]
0
0
2019-000204-14
Query!
Secondary ID [2]
0
0
GS-US-428-4194
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
PRIMIS
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Primary Sclerosing Cholangitis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Infection
0
0
0
0
Query!
Other infectious diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Cilofexor
Treatment: Drugs - Placebo
Experimental: Cilofexor 100 mg (Blinded Phase) - Participants received cilofexor 100 mg tablet, orally, once daily for up to 100.3 weeks.
Placebo Comparator: Placebo (Blinded Phase) - Participants received placebo to match cilofexor 100 mg tablet, orally, once daily for up to 98.1 weeks.
Experimental: Cilofexor From Cilofexor 100 mg (OLE Phase) - Participants who received cilofexor in blinded phase and had entered the open-label extension (OLE) phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 44.7 weeks.
Experimental: Cilofexor From Placebo (OLE Phase) - Participants who received placebo in blinded phase and had entered the OLE phase received open-label cilofexor 100 mg tablet, orally, once daily for up to 45.0 weeks.
Treatment: Drugs: Cilofexor
100 mg tablet administered orally once daily
Treatment: Drugs: Placebo
Tablet administered orally once daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96
Query!
Assessment method [1]
0
0
Progression of liver fibrosis was defined as having a = 1-stage increase from baseline in fibrosis according to the Ludwig classification at Blinded Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).
Query!
Timepoint [1]
0
0
Blinded Phase Week 96
Query!
Secondary outcome [1]
0
0
Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) in The Blinded Phase
Query!
Assessment method [1]
0
0
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.
Query!
Timepoint [1]
0
0
First dose date in the Blinded Phase up to 100.3 weeks plus 30 days
Query!
Secondary outcome [2]
0
0
Percentage of Participants Who Experienced TEAEs in The OLE Phase
Query!
Assessment method [2]
0
0
An AE was any untoward medical occurrence in a clinical study participant administered a study drug that does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a study drug, whether or not the AE is considered related to the study drug. For Blinded Study Phase and OLE Phase, TEAEs were defined as 1 or both of the following: Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.
Query!
Timepoint [2]
0
0
First dose date in the OLE Phase up to 45 weeks plus 30 days
Query!
Secondary outcome [3]
0
0
Percentage of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs) in the Blinded Phase
Query!
Assessment method [3]
0
0
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Query!
Timepoint [3]
0
0
First dose date in the Blinded Phase up to 100.3 weeks plus 30 days
Query!
Secondary outcome [4]
0
0
Percentage of Participants Who Experienced Treatment-emergent SAEs in the OLE Phase
Query!
Assessment method [4]
0
0
An SAE was defined as an event that, at any dose, results in the following: death, a life-threatening situation; in-patient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, a congenital anomaly/birth defect or a medically important event or reaction.
Query!
Timepoint [4]
0
0
First dose date in the OLE Phase up to 45 weeks plus 30 days
Query!
Secondary outcome [5]
0
0
Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96
Query!
Assessment method [5]
0
0
Query!
Timepoint [5]
0
0
Baseline, Blinded Phase Week 96
Query!
Secondary outcome [6]
0
0
Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Blinded Phase Week 96
Query!
Assessment method [6]
0
0
Query!
Timepoint [6]
0
0
Baseline, Blinded Phase Week 96
Query!
Secondary outcome [7]
0
0
Change From Baseline in Serum Concentrations of Fasting Total Bile Acids at Blinded Phase Week 96
Query!
Assessment method [7]
0
0
Query!
Timepoint [7]
0
0
Baseline, Blinded Phase Week 96
Query!
Secondary outcome [8]
0
0
Percentage of Participants With = 25% Relative Reduction in Serum ALP Concentration From Baseline and No Worsening of Fibrosis According to the Ludwig Classification at Blinded Phase Week 96
Query!
Assessment method [8]
0
0
The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).The percentage of participants with = 25% reduction in serum ALP Concentration from baseline and no increase in fibrosis according to the Ludwig Classification at Blinded Phase Week 96 was analyzed.
Query!
Timepoint [8]
0
0
Baseline, Blinded Phase Week 96
Query!
Secondary outcome [9]
0
0
Percentage of Participants With Fibrosis Improvement According to the Ludwig Classification at Blinded Phase Week 96
Query!
Assessment method [9]
0
0
Fibrosis improvement was defined as having = 1-stage decrease from baseline in fibrosis according to the Ludwig classification score at Blinded Study Phase Week 96. The stages of fibrosis was assessed according to Ludwig classification. Ludwig classification fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=no fibrosis, 4=cirrhosis).
Query!
Timepoint [9]
0
0
Blinded Phase Week 96
Query!
Secondary outcome [10]
0
0
Change From Baseline in Primary Sclerosing Cholangitis (PSC) Symptoms - Module 1 Based on Disease-specific Patient Reported Outcome (PSC-PRO) at Blinded Phase Week 96
Query!
Assessment method [10]
0
0
The PSC-PRO addressed the severity of common everyday symptoms of PSC (eg, pruritus, fatigue, and right upper quadrant abdominal discomfort); and their functional impact (eg, on physical function, activities of daily living, and work productivity, etc). PSC-PRO module 1 - PSC symptoms contains a total of 12 questions asking about the severity of specific PSC symptoms on a scale of 0 (no symptoms) to 10 (symptoms as bad as you could imagine) with a 24-hour recall period. The total score, which is computed as 12 times the average of nonmissing scores of the 12 questions, can potentially range between 0 and 120, with higher scores indicating more severe symptoms. A positive change from baseline indicates worsening of symptoms.
Query!
Timepoint [10]
0
0
Baseline, Blinded Phase Week 96
Query!
Secondary outcome [11]
0
0
Change From Baseline in Enhanced Liver Fibrosis (ELF™ ) Test Score at Blinded Phase Week 96
Query!
Assessment method [11]
0
0
The Enhanced Liver Fibrosis (ELF™) test is a composite of three serum biomarkers of hepatobiliary fibrosis: hyaluronic acid, procollagen III amino-terminal peptide, and tissue inhibitor of metalloproteinase. A typical range for ELF™ test scores in PSC is between 6 and 14. Higher ELF™ test scores are associated with more severe liver disease. A positive change from baseline indicated worsening of fibrosis.
Query!
Timepoint [11]
0
0
Baseline, Blinded Phase Week 96
Query!
Secondary outcome [12]
0
0
Change From Baseline in Liver Stiffness by FibroScan® at Blinded Phase Week 96
Query!
Assessment method [12]
0
0
Change in liver stiffness was measured by FibroScan® scores. FibroScan measures liver scarring by measuring the stiffness of the liver. It's normally between 2 and 6 kPa. Many people with liver disease(s) have a result that's higher than the normal range. Higher scores indicate increased scarring of the liver. A positive change from baseline indicates severe liver disease(s).
Query!
Timepoint [12]
0
0
Baseline, Blinded Phase Week 96
Query!
Eligibility
Key inclusion criteria
Key
- Diagnosis of large duct PSC
- Liver biopsy at screening that is deemed acceptable for interpretation and
demonstrates stage F0 - F3 fibrosis in the opinion of the central reader
- Individual has the following laboratory parameters at the screening visit, as
determined by the central laboratory:
- Platelet count = 150,000/mm^3
- Estimated glomerular filtration rate (eGFR) = 30 milliliter/minute (mL/min), as
calculated by the Cockcroft-Gault equation
- Alanine transaminase (ALT) = 8 x upper limit of the normal range (ULN)
- Total bilirubin < 2 mg/dL, unless the individual is known to have Gilbert's
syndrome or hemolytic anemia
- International normalized ratio (INR) = 1.4, unless due to therapeutic
anticoagulation
- Negative anti-mitochondrial antibody
Key
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
- Current or prior history of any of the following:
- Cirrhosis
- Liver transplantation
- Cholangiocarcinoma or hepatocellular carcinoma (HCC)
- Ascending cholangitis within 30 days of screening
- Presence of a percutaneous drain or biliary stent
- Other causes of liver disease
- Current or prior history of unstable cardiovascular disease
- Current moderate to severe inflammatory bowel disease (IBD) (including ulcerative
colitis, Crohn's disease, and indeterminate colitis)
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Terminated
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
27/03/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
23/12/2022
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
419
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Royal Prince Alfred Hospital - Camperdown
Query!
Recruitment hospital [2]
0
0
St. Vincent's Hospital Sydney - Darlinghurst
Query!
Recruitment hospital [3]
0
0
Nepean Hospital - Penrith
Query!
Recruitment hospital [4]
0
0
Westmead Hospital - Westmead
Query!
Recruitment hospital [5]
0
0
Coral Sea Clinical Research Institute - Mackay - Auchenflower
Query!
Recruitment hospital [6]
0
0
Royal Brisbane and Women's Hospital - Herston
Query!
Recruitment hospital [7]
0
0
Mater Misericordiae Ltd - South Brisbane
Query!
Recruitment hospital [8]
0
0
Monash Health - Clayton
Query!
Recruitment hospital [9]
0
0
Austin Health - Heidelberg
Query!
Recruitment hospital [10]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment hospital [11]
0
0
The Royal Melbourne Hospital - Parkville
Query!
Recruitment hospital [12]
0
0
Sir Charles Gairdner Hospital - Nedlands
Query!
Recruitment hospital [13]
0
0
Royal Perth Hospital - Perth
Query!
Recruitment postcode(s) [1]
0
0
2050 - Camperdown
Query!
Recruitment postcode(s) [2]
0
0
2010 - Darlinghurst
Query!
Recruitment postcode(s) [3]
0
0
2751 - Penrith
Query!
Recruitment postcode(s) [4]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [5]
0
0
4066 - Auchenflower
Query!
Recruitment postcode(s) [6]
0
0
4029 - Herston
Query!
Recruitment postcode(s) [7]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [8]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [9]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [10]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [11]
0
0
3050 - Parkville
Query!
Recruitment postcode(s) [12]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [13]
0
0
6000 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Colorado
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
District of Columbia
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Indiana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kansas
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Massachusetts
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Michigan
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Minnesota
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Mississippi
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Missouri
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Nebraska
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New York
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
North Carolina
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Ohio
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Pennsylvania
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Rhode Island
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
South Carolina
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
South Dakota
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Tennessee
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Texas
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Utah
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Vermont
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Virginia
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Washington
Query!
Country [33]
0
0
Austria
Query!
State/province [33]
0
0
Klagenfurt am Wörthersee
Query!
Country [34]
0
0
Austria
Query!
State/province [34]
0
0
Vienna
Query!
Country [35]
0
0
Belgium
Query!
State/province [35]
0
0
Bruxelles
Query!
Country [36]
0
0
Belgium
Query!
State/province [36]
0
0
Edegem
Query!
Country [37]
0
0
Belgium
Query!
State/province [37]
0
0
Gent
Query!
Country [38]
0
0
Belgium
Query!
State/province [38]
0
0
Ghent
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Leuven
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Liege
Query!
Country [41]
0
0
Canada
Query!
State/province [41]
0
0
Brampton
Query!
Country [42]
0
0
Canada
Query!
State/province [42]
0
0
Calgary
Query!
Country [43]
0
0
Canada
Query!
State/province [43]
0
0
Edmonton
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
Halifax
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Hamilton
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Montreal
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Toronto
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Vancouver
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
Winnipeg
Query!
Country [50]
0
0
Denmark
Query!
State/province [50]
0
0
Aalborg
Query!
Country [51]
0
0
Denmark
Query!
State/province [51]
0
0
København Ø
Query!
Country [52]
0
0
Finland
Query!
State/province [52]
0
0
Helsinki
Query!
Country [53]
0
0
Finland
Query!
State/province [53]
0
0
Turku
Query!
Country [54]
0
0
France
Query!
State/province [54]
0
0
Herault
Query!
Country [55]
0
0
France
Query!
State/province [55]
0
0
Amiens
Query!
Country [56]
0
0
France
Query!
State/province [56]
0
0
CHRU Lille
Query!
Country [57]
0
0
France
Query!
State/province [57]
0
0
Creteil
Query!
Country [58]
0
0
France
Query!
State/province [58]
0
0
Grenoble cedex 09
Query!
Country [59]
0
0
France
Query!
State/province [59]
0
0
Marseille
Query!
Country [60]
0
0
France
Query!
State/province [60]
0
0
Paris
Query!
Country [61]
0
0
France
Query!
State/province [61]
0
0
Pessac
Query!
Country [62]
0
0
France
Query!
State/province [62]
0
0
Reims
Query!
Country [63]
0
0
France
Query!
State/province [63]
0
0
Strasbourg
Query!
Country [64]
0
0
France
Query!
State/province [64]
0
0
Toulouse cedex
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Toulouse
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Villejuif
Query!
Country [67]
0
0
Germany
Query!
State/province [67]
0
0
Berlin
Query!
Country [68]
0
0
Germany
Query!
State/province [68]
0
0
Essen
Query!
Country [69]
0
0
Germany
Query!
State/province [69]
0
0
Frankfurt am Main
Query!
Country [70]
0
0
Germany
Query!
State/province [70]
0
0
Hannover
Query!
Country [71]
0
0
Germany
Query!
State/province [71]
0
0
Heidelberg
Query!
Country [72]
0
0
Germany
Query!
State/province [72]
0
0
Homburg
Query!
Country [73]
0
0
Germany
Query!
State/province [73]
0
0
Kiel
Query!
Country [74]
0
0
Germany
Query!
State/province [74]
0
0
Leipzig
Query!
Country [75]
0
0
Germany
Query!
State/province [75]
0
0
Mainz
Query!
Country [76]
0
0
Germany
Query!
State/province [76]
0
0
Mannheim
Query!
Country [77]
0
0
Israel
Query!
State/province [77]
0
0
Afula
Query!
Country [78]
0
0
Israel
Query!
State/province [78]
0
0
Haifa
Query!
Country [79]
0
0
Israel
Query!
State/province [79]
0
0
Jerusalem
Query!
Country [80]
0
0
Israel
Query!
State/province [80]
0
0
Petah Tikva
Query!
Country [81]
0
0
Israel
Query!
State/province [81]
0
0
Ramat Gan
Query!
Country [82]
0
0
Israel
Query!
State/province [82]
0
0
Tel-Aviv
Query!
Country [83]
0
0
Italy
Query!
State/province [83]
0
0
Foggia
Query!
Country [84]
0
0
Italy
Query!
State/province [84]
0
0
Ancona
Query!
Country [85]
0
0
Italy
Query!
State/province [85]
0
0
Bologna
Query!
Country [86]
0
0
Italy
Query!
State/province [86]
0
0
Milan
Query!
Country [87]
0
0
Italy
Query!
State/province [87]
0
0
Novara
Query!
Country [88]
0
0
Italy
Query!
State/province [88]
0
0
Padova
Query!
Country [89]
0
0
Italy
Query!
State/province [89]
0
0
Palermo
Query!
Country [90]
0
0
Italy
Query!
State/province [90]
0
0
Pisa
Query!
Country [91]
0
0
Italy
Query!
State/province [91]
0
0
Rome
Query!
Country [92]
0
0
Italy
Query!
State/province [92]
0
0
Rozzano (Milan)
Query!
Country [93]
0
0
Italy
Query!
State/province [93]
0
0
Rozzano
Query!
Country [94]
0
0
Japan
Query!
State/province [94]
0
0
Chiba-shi
Query!
Country [95]
0
0
Japan
Query!
State/province [95]
0
0
Hiroshima
Query!
Country [96]
0
0
Japan
Query!
State/province [96]
0
0
Nagasaki
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Okayama-shi
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Sendai
Query!
Country [99]
0
0
Japan
Query!
State/province [99]
0
0
Suita
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Tokyo
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Toon-Shi
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Yamagata
Query!
Country [103]
0
0
New Zealand
Query!
State/province [103]
0
0
Auckland
Query!
Country [104]
0
0
New Zealand
Query!
State/province [104]
0
0
Christchurch
Query!
Country [105]
0
0
New Zealand
Query!
State/province [105]
0
0
Hamilton
Query!
Country [106]
0
0
Spain
Query!
State/province [106]
0
0
Alicante
Query!
Country [107]
0
0
Spain
Query!
State/province [107]
0
0
Barcelona
Query!
Country [108]
0
0
Spain
Query!
State/province [108]
0
0
Madrid
Query!
Country [109]
0
0
Spain
Query!
State/province [109]
0
0
Majadahonda
Query!
Country [110]
0
0
Spain
Query!
State/province [110]
0
0
Pontevedra
Query!
Country [111]
0
0
Spain
Query!
State/province [111]
0
0
Santiago de Compostela
Query!
Country [112]
0
0
Spain
Query!
State/province [112]
0
0
Valencia
Query!
Country [113]
0
0
Spain
Query!
State/province [113]
0
0
Zaragoza
Query!
Country [114]
0
0
Switzerland
Query!
State/province [114]
0
0
Bern
Query!
Country [115]
0
0
Switzerland
Query!
State/province [115]
0
0
Lugano
Query!
Country [116]
0
0
Switzerland
Query!
State/province [116]
0
0
Zurich
Query!
Country [117]
0
0
United Kingdom
Query!
State/province [117]
0
0
Birmingham
Query!
Country [118]
0
0
United Kingdom
Query!
State/province [118]
0
0
Cambridge
Query!
Country [119]
0
0
United Kingdom
Query!
State/province [119]
0
0
Glasgow
Query!
Country [120]
0
0
United Kingdom
Query!
State/province [120]
0
0
Leeds
Query!
Country [121]
0
0
United Kingdom
Query!
State/province [121]
0
0
Liverpool
Query!
Country [122]
0
0
United Kingdom
Query!
State/province [122]
0
0
London
Query!
Country [123]
0
0
United Kingdom
Query!
State/province [123]
0
0
Nottingham
Query!
Country [124]
0
0
United Kingdom
Query!
State/province [124]
0
0
Oxford
Query!
Country [125]
0
0
United Kingdom
Query!
State/province [125]
0
0
Portsmouth
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Gilead Sciences
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The primary objective of this study is to evaluate whether cilofexor reduces the risk of
fibrosis progression among non-cirrhotic adults with primary sclerosing cholangitis (PSC).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03890120
Query!
Trial related presentations / publications
Trauner M, Chung C, Sterling K, Liu X, Lu X, Xu J, Tempany-Afdhal C, Goodman ZD, Farkkila M, Tanaka A, Trivedi P, Kowdley KV, Bowlus CL, Levy C, Myers RP. PRIMIS: design of a pivotal, randomized, phase 3 study evaluating the safety and efficacy of the nonsteroidal farnesoid X receptor agonist cilofexor in noncirrhotic patients with primary sclerosing cholangitis. BMC Gastroenterol. 2023 Mar 15;23(1):75. doi: 10.1186/s12876-023-02653-2.
Trauner M, Levy C, Tanaka A, Goodman Z, Thorburn D, et al. A Phase 3 Randomized, Double-blind, Placebo-controlled Study Evaluation the Efficacy and Safety of Cilofexor in Patients With Non-cirrhotic Patients With Primary Sclerosing Cholangitis. J Hepatol. 2023 June;78(S1):S12-S13.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Gilead Study Director
Query!
Address
0
0
Gilead Sciences
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03890120
Download to PDF