Trial · NCT03890120
Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
NCT03890120, Phase 3, Terminated, Gilead Sciences; results first posted 2023-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Cilofexor in Adults With Primary Sclerosing Cholangitis. Trials, record NCT03890120. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03890120
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cilofexor in Adults With Primary Sclerosing Cholangitis
- NCT number
- NCT03890120
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 419 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Primary Sclerosing Cholangitis
- Interventions
- Cilofexor, Placebo
- First posted
- 2019-03-26
- Last updated
- 2023-11-29
- Other registries' IDs
- eudract:2019-000204-14
- Results first posted
- 2023-11-29
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96 | Blinded Phase Week 96 | 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). |
| Secondary | Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) in The Blinded Phase | First dose date in the Blinded Phase up to 100.3 weeks plus 30 days | 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. |
| Secondary | Percentage of Participants Who Experienced TEAEs in The OLE Phase | First dose date in the OLE Phase up to 45 weeks plus 30 days | 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. |
| Secondary | Percentage of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs) in the Blinded Phase | First dose date in the Blinded Phase up to 100.3 weeks plus 30 days | 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. |
| Secondary | Percentage of Participants Who Experienced Treatment-emergent SAEs in the OLE Phase | First dose date in the OLE Phase up to 45 weeks plus 30 days | 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. |
| Secondary | Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96 | Baseline, Blinded Phase Week 96 | |
| Secondary | Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Blinded Phase Week 96 | Baseline, Blinded Phase Week 96 | |
| Secondary | Change From Baseline in Serum Concentrations of Fasting Total Bile Acids at Blinded Phase Week 96 | Baseline, Blinded Phase Week 96 | |
| Secondary | 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 | Baseline, 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).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. |
| Secondary | Percentage of Participants With Fibrosis Improvement According to the Ludwig Classification at Blinded Phase Week 96 | Blinded Phase Week 96 | 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). |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96 | Blinded Phase Week 96 | Full Analysis Set included all randomized participants who took at least 1 dose of study drug. Participants in the Full Analysis Set who had nonmissing data at both baseline and Week 96 in the Blinded Study Phase were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) in The Blinded Phase | First dose date in the Blinded Phase up to 100.3 weeks plus 30 days | Safety Analysis Set included all participants who took at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced TEAEs in The OLE Phase | First dose date in the OLE Phase up to 45 weeks plus 30 days | OLE Analysis Set included all participants who took at least 1 dose of study drug in the OLE Phase. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs) in the Blinded Phase | First dose date in the Blinded Phase up to 100.3 weeks plus 30 days | Participants in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced Treatment-emergent SAEs in the OLE Phase | First dose date in the OLE Phase up to 45 weeks plus 30 days | Participants in the OLE Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Serum Concentrations of Alkaline Phosphatase (ALP) at Blinded Phase Week 96 | Baseline, Blinded Phase Week 96 | Participants in the Full Analysis Set with available data were analyzed. | units per liter (U/L) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Serum Concentrations of Alanine Aminotransferase (ALT) at Blinded Phase Week 96 | Baseline, Blinded Phase Week 96 | Participants in the Full Analysis Set with available data were analyzed. | U/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Serum Concentrations of Fasting Total Bile Acids at Blinded Phase Week 96 | Baseline, Blinded Phase Week 96 | Participants in the Full Analysis Set with available data were analyzed. | micromoles per liter (μmol/L) | LEAST_SQUARES_MEAN |
| SECONDARY | 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 | Baseline, Blinded Phase Week 96 | Participants in the Full Analysis Set with available data who had nonmissing data at both baseline and Week 96 in the blinded phase were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Fibrosis Improvement According to the Ludwig Classification at Blinded Phase Week 96 | Blinded Phase Week 96 | Participants in the Full Analysis Set with available data who had nonmissing data at both baseline and Week 96 in the blinded phase were analyzed. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96 | Cilofexor 100 mg (Blinded Phase) | 30.8 | percentage of participants | ||
| Percentage of Participants With Progression of Liver Fibrosis at Blinded Phase Week 96 | Placebo (Blinded Phase) | 32.8 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) in The Blinded Phase | Cilofexor 100 mg (Blinded Phase) | 97.1 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) in The Blinded Phase | Placebo (Blinded Phase) | 95.0 | percentage of participants | ||
| Percentage of Participants Who Experienced TEAEs in The OLE Phase | Cilofexor From Cilofexor 100 mg (OLE Phase) | 66.3 | percentage of participants | ||
| Percentage of Participants Who Experienced TEAEs in The OLE Phase | Cilofexor From Placebo (OLE Phase) | 73.3 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs) in the Blinded Phase | Cilofexor 100 mg (Blinded Phase) | 19.1 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-emergent Serious Adverse Events (SAEs) in the Blinded Phase | Placebo (Blinded Phase) | 18.7 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-emergent SAEs in the OLE Phase | Cilofexor From Cilofexor 100 mg (OLE Phase) | 11.3 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-emergent SAEs in the OLE Phase | Cilofexor From Placebo (OLE Phase) | 2.2 | percentage of participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Blinded Treatment Phase (100.3 Weeks) | STARTED | Cilofexor 100 mg (Blinded Phase) | 278 | |
| Blinded Treatment Phase (100.3 Weeks) | STARTED | Placebo (Blinded Phase) | 141 | |
| Blinded Treatment Phase (100.3 Weeks) | STARTED | Cilofexor From Cilofexor 100 mg (OLE Phase) | 0 | |
| Blinded Treatment Phase (100.3 Weeks) | STARTED | Cilofexor From Placebo (OLE Phase) | 0 | |
| Blinded Treatment Phase (100.3 Weeks) | COMPLETED | Cilofexor 100 mg (Blinded Phase) | 123 | |
| Blinded Treatment Phase (100.3 Weeks) | COMPLETED | Placebo (Blinded Phase) | 66 | |
| Blinded Treatment Phase (100.3 Weeks) | COMPLETED | Cilofexor From Cilofexor 100 mg (OLE Phase) | 0 | |
| Blinded Treatment Phase (100.3 Weeks) | COMPLETED | Cilofexor From Placebo (OLE Phase) | 0 | |
| Blinded Treatment Phase (100.3 Weeks) | NOT COMPLETED | Cilofexor 100 mg (Blinded Phase) | 155 | |
| Blinded Treatment Phase (100.3 Weeks) | NOT COMPLETED | Placebo (Blinded Phase) | 75 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events416
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Cilofexor 100 mg (Blinded Phase) | 9 | 277 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo (Blinded Phase) | 9 | 139 | |
| other | Abdominal distension | Gastrointestinal disorders | Cilofexor From Cilofexor 100 mg (OLE Phase) | 0 | 80 | |
| other | Abdominal distension | Gastrointestinal disorders | Cilofexor From Placebo (OLE Phase) | 2 | 45 | |
| other | Abdominal pain | Gastrointestinal disorders | Cilofexor 100 mg (Blinded Phase) | 38 | 277 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo (Blinded Phase) | 17 | 139 | |
| other | Abdominal pain | Gastrointestinal disorders | Cilofexor From Cilofexor 100 mg (OLE Phase) | 1 | 80 | |
| other | Abdominal pain | Gastrointestinal disorders | Cilofexor From Placebo (OLE Phase) | 0 | 45 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Cilofexor 100 mg (Blinded Phase) | 40 | 277 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo (Blinded Phase) | 20 | 139 |
1 to 10 of 416Source ClinicalTrials.gov
See all 416 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cilofexor 100 mg (Blinded Phase) | 2 | 278 |
| Total, all-cause mortality | Placebo (Blinded Phase) | 0 | 141 |
| Total, all-cause mortality | Cilofexor From Cilofexor 100 mg (OLE Phase) | 0 | 80 |
| Total, all-cause mortality | Cilofexor From Placebo (OLE Phase) | 0 | 45 |
| Total, other adverse events | Cilofexor 100 mg (Blinded Phase) | 232 | 277 |
| Total, other adverse events | Placebo (Blinded Phase) | 109 | 139 |
| Total, other adverse events | Cilofexor From Cilofexor 100 mg (OLE Phase) | 34 | 80 |
| Total, other adverse events | Cilofexor From Placebo (OLE Phase) | 24 | 45 |
| Total, serious adverse events | Cilofexor 100 mg (Blinded Phase) | 53 | 277 |
| Total, serious adverse events | Placebo (Blinded Phase) | 26 | 139 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03890120
GET https://conductscience.org/api/trials/v1/NCT03890120/results?page=2