Trial · NCT03226067
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
NCT03226067, Phase 2, Completed, Asahi Kasei Therapeutics, AB; results first posted 2022-03-31
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol. Trials, record NCT03226067. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03226067
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
- NCT number
- NCT03226067
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 111 participants, actual
- Lead sponsor
- Asahi Kasei Therapeutics, AB
- Conditions
- Primary Biliary Cirrhosis
- Interventions
- GKT137831, Placebo oral capsule
- First posted
- 2017-07-21
- Last updated
- 2022-06-29
- Other registries' IDs
- eudract:2016-004599-23
- Results first posted
- 2022-03-31
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percent Change in Serum GGT. | Baseline to week 24 (visit 7) | Percent change in serum GGT from baseline to Week 24 (serum GGT was measured in U/L) |
| Secondary | Absolute Change in Serum GGT | From baseline to Weeks 2, 6, 12, 18 and 24 | Absolute change in serum GGT from baseline to each assessment. |
| Secondary | Percent Change in Serum GGT | From baseline to Weeks 2, 6, 12, 18 and 24 | Percent change in serum GGT from baseline to each assessment (serum GGT was measured in U/L) |
| Secondary | Percent Change in Serum ALP | From baseline to Weeks 2, 6, 12, 18 and 24 | Percent change in serum ALP from baseline to each assessment (serum ALP was measured in U/L). |
| Secondary | Absolute Change in Serum ALP | From baseline to Weeks 2, 6, 12, 18 and 24 | Absolute change in serum ALP from baseline to each assessment. |
| Secondary | Absolute Change in Serum Conjugated Bilirubin. | From baseline to Weeks 2, 6, 12, 18 and 24 | Absolute change in serum conjugated bilirubin from baseline to each assessment. |
| Secondary | Percent Change in Serum Conjugated Bilirubin. | From baseline to Weeks 2, 6, 12, 18 and 24 | Percent change in serum Conjugated bilirubin, from baseline to each assessment (serum conjugated bilirubin is measured in μmol/L). |
| Secondary | Absolute Change in Serum Total Bilirubin. | from baseline to Weeks 2, 6, 12, 18 and 24 | Absolute change in serum total bilirubin, from baseline to each assessment. |
| Secondary | Percent Change in Serum Total Bilirubin. | from baseline to Weeks 2, 6, 12, 18 and 24 | Percent change in Serum Total Bilirubin from baseline to each assessment (serum total bilirubin is measured in μmol/L). |
| Secondary | Absolute Change in Liver Stiffness as Assessed by Transient Elastography (FibroScan® or Similar Technology). | From baseline to Week 24, in patients with values at baseline and Week 24. | Absolute change in liver stiffness as assessed by transient elastography (FibroScan® or similar technology), from baseline to Week 24, in subjects with values at baseline and Week 24. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percent Change in Serum GGT. | Baseline to week 24 (visit 7) | Number of subjects analyzed in the Intent to Treat population who have evaluable results | percent change | MEAN |
| SECONDARY | Absolute Change in Serum GGT | From baseline to Weeks 2, 6, 12, 18 and 24 | Number of subjects analyzed in the Intent to Treat population who have evaluable results | U/L | MEAN |
| SECONDARY | Percent Change in Serum GGT | From baseline to Weeks 2, 6, 12, 18 and 24 | Number of subjects analyzed in the Intent to Treat population who have evaluable results | percent change | MEAN |
| SECONDARY | Percent Change in Serum ALP | From baseline to Weeks 2, 6, 12, 18 and 24 | Number of subjects analyzed in the Intent to Treat population who have evaluable results | percent change | MEAN |
| SECONDARY | Absolute Change in Serum ALP | From baseline to Weeks 2, 6, 12, 18 and 24 | Number of subjects analyzed in the Intent to Treat population who have evaluable results | U/L | MEAN |
| SECONDARY | Absolute Change in Serum Conjugated Bilirubin. | From baseline to Weeks 2, 6, 12, 18 and 24 | Number of subjects analyzed in the Intent to Treat population who have evaluable results | μmol/L | MEAN |
| SECONDARY | Percent Change in Serum Conjugated Bilirubin. | From baseline to Weeks 2, 6, 12, 18 and 24 | Number of subjects analyzed in the Intent to Treat population who have evaluable results | percent change | MEAN |
| SECONDARY | Absolute Change in Serum Total Bilirubin. | from baseline to Weeks 2, 6, 12, 18 and 24 | Number of subjects analyzed in the Intent to Treat population who have evaluable results | μmol/L | MEAN |
| SECONDARY | Percent Change in Serum Total Bilirubin. | from baseline to Weeks 2, 6, 12, 18 and 24 | Number of subjects analyzed in the Intent to Treat population who have evaluable results | percent change | MEAN |
| SECONDARY | Absolute Change in Liver Stiffness as Assessed by Transient Elastography (FibroScan® or Similar Technology). | From baseline to Week 24, in patients with values at baseline and Week 24. | Number of subjects analyzed in the Intent to Treat population who have evaluable results | kPa | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group249
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percent Change in Serum GGT. | GKT137831 400mg Once Daily | -4.9 | Standard Deviation 59.58 | percent change | |
| The Percent Change in Serum GGT. | GKT137831 400mg Twice Daily | -19 | Standard Deviation 28.89 | percent change | |
| The Percent Change in Serum GGT. | Placebo Arm | -8.4 | Standard Deviation 21.45 | percent change | |
| Absolute Change in Serum GGT | GKT137831 400mg Once Daily | Absolute change W2 | -14.3 | Standard Deviation 112.66 | U/L |
| Absolute Change in Serum GGT | GKT137831 400mg Twice Daily | Absolute change W2 | -48.5 | Standard Deviation 61.83 | U/L |
| Absolute Change in Serum GGT | Placebo Arm | Absolute change W2 | -11.2 | Standard Deviation 45.96 | U/L |
| Absolute Change in Serum GGT | GKT137831 400mg Once Daily | Absolute change W6 | -22.2 | Standard Deviation 76.68 | U/L |
| Absolute Change in Serum GGT | GKT137831 400mg Twice Daily | Absolute change W6 | -53.5 | Standard Deviation 67.57 | U/L |
| Absolute Change in Serum GGT | Placebo Arm | Absolute change W6 | -17.9 | Standard Deviation 59.01 | U/L |
| Absolute Change in Serum GGT | GKT137831 400mg Once Daily | Absolute change W12 | -3.9 | Standard Deviation 115.13 | U/L |
1 to 10 of 249Source ClinicalTrials.gov
See all 249 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GKT137831 400mg Twice Daily | 36 | |
| Overall Study | STARTED | GKT137831 400mg Once Daily | 38 | |
| Overall Study | STARTED | Placebo Arm | 37 | |
| Overall Study | COMPLETED | GKT137831 400mg Twice Daily | 36 | |
| Overall Study | COMPLETED | GKT137831 400mg Once Daily | 38 | |
| Overall Study | COMPLETED | Placebo Arm | 37 | |
| Overall Study | NOT COMPLETED | GKT137831 400mg Twice Daily | 0 | |
| Overall Study | NOT COMPLETED | GKT137831 400mg Once Daily | 0 | |
| Overall Study | NOT COMPLETED | Placebo Arm | 0 |
Source ClinicalTrials.gov
Adverse events72
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 | Nausea | Gastrointestinal disorders | GKT137831 400mg Twice Daily | 6 | 36 | 7 |
| other | Nausea | Gastrointestinal disorders | GKT137831 400mg Once Daily | 3 | 38 | 3 |
| other | Nausea | Gastrointestinal disorders | Placebo Arm | 4 | 37 | 6 |
| other | Abdominal Pain | Gastrointestinal disorders | GKT137831 400mg Twice Daily | 3 | 36 | 3 |
| other | Abdominal Pain | Gastrointestinal disorders | GKT137831 400mg Once Daily | 3 | 38 | 4 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo Arm | 0 | 37 | 0 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | GKT137831 400mg Twice Daily | 2 | 36 | 2 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | GKT137831 400mg Once Daily | 2 | 38 | 2 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | Placebo Arm | 2 | 37 | 2 |
| other | Constipation | Gastrointestinal disorders | GKT137831 400mg Twice Daily | 3 | 36 | 4 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GKT137831 400mg Twice Daily | 0 | 36 |
| Total, all-cause mortality | GKT137831 400mg Once Daily | 0 | 38 |
| Total, all-cause mortality | Placebo Arm | 0 | 37 |
| Total, other adverse events | GKT137831 400mg Twice Daily | 32 | 36 |
| Total, other adverse events | GKT137831 400mg Once Daily | 34 | 38 |
| Total, other adverse events | Placebo Arm | 31 | 37 |
| Total, serious adverse events | GKT137831 400mg Twice Daily | 1 | 36 |
| Total, serious adverse events | GKT137831 400mg Once Daily | 0 | 38 |
| Total, serious adverse events | Placebo Arm | 1 | 37 |
Source ClinicalTrials.gov
Papers2
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT03226067
GET https://conductscience.org/api/trials/v1/NCT03226067/results?page=2