Trial · NCT02966834
Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
NCT02966834, Phase 2, Completed, GlaxoSmithKline; results first posted 2021-05-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis. Trials, record NCT02966834. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02966834
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dose Response Study of GSK2330672 for the Treatment of Pruritus in Participants With Primary Biliary Cholangitis
- NCT number
- NCT02966834
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 147 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Cholestasis
- Interventions
- Placebo, GSK2330672
- First posted
- 2016-11-17
- Last updated
- 2021-05-04
- Other registries' IDs
- eudract:2016-002416-41
- Results first posted
- 2021-05-04
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | Baseline and Week 16 | Participants were required to score the severity of their itching using a 0-10 numerical rating scale (NRS) where 0 represents no itching and 10 indicates the worst imaginable itching. The Worst Daily Itch Score is the most severe (highest) NRS recorded on a given day. Mean Worst Daily Itch score was calculated as the average of the worst daily itch scores provided in the 7 days prior to the Week 16 visit. Baseline is the average of the scores in the 7 days prior to the Week 4 (Visit 3 \[V3\]). Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was done using Analysis of covariance (ANCOVA) including treatment group and centered Mean Worst Daily Itch score at Baseline. |
| Secondary | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Baseline and at Week 16 | PBC-40 is a disease-specific health-related quality of life (HRQoL) questionnaire for use in PBC participants. It consists of 40 questions arranged in 6 domains with 3 to 11 questions in each domain. Each question is scored from 1 (least impact) to 5 (greatest impact). All questions within a domain are summed to obtain individual domain score. Domains were: Symptoms (7 questions) with score range 7-35, Itch (3 questions) with score range 3-15, Fatigue (11 questions) with score range 11-55, Cognitive (6 questions) with score range 6-30, Emotional (3 questions) with score range 3-15, and Social (10 questions) with score range 10-50. Higher scores for individual domains represent a poor quality of life. Baseline is the assessment performed at Week 4 (V3) which is conducted prior to first dosing of randomized medication that evening. Change from Baseline was calculated as post-Baseline value minus Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline. |
| Secondary | Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression | Baseline and at Week 16 | Criteria for high risk of PBC progression is defined as serum ALP concentrations more than or equal to (\>=)1.67 times upper limit of normal (ULN) range and/or total bilirubin concentrations more than (\>)ULN at Day 1. Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 (Day 1) or Visit 1 (Screening), excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline. |
| Secondary | Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16 | At Week 16 | Number of participants with ALP \< 1.67 times ULN and total bilirubin \<= ULN at Week 16 is presented. The endpoint was analyzed in Restricted High Risk Population. |
| Secondary | Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline. |
| Secondary | Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including Treatment group and Baseline. |
| Secondary | Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline. |
| Secondary | Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline. |
| Secondary | Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA including treatment group and Baseline. |
| Secondary | Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | Baseline is the assessment performed at Week 4 (V3), or if missing then Visit 2 or Visit 1, excluding unscheduled visits. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using ANCOVA model including treatment group and Baseline. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | Baseline and Week 16 | Intent-to-Treat (ITT) Population comprised of all randomized participants who received at least one dose of study treatment, had a Baseline and at least one on-treatment assessment. Only those participants with data available at the specified data points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Baseline and at Week 16 | ITT Population. Only those participants with data available at the specified data points were analyzed. | Scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Serum Alkaline Phosphatase (ALP) Concentrations, in Participants With High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population comprised of subset of the ITT population who were assigned to the High Risk stratum for randomization (based upon serum ALP concentrations \>=1.67 times ULN and/or total bilirubin concentrations \>ULN at Day 1 (Visit 2). Only those participants with data available at the specified data points were analyzed. | International units per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Serum ALP Concentrations Less Than (<)1.67 Times ULN and Total Bilirubin Concentrations Less Than or Equal to (<=) ULN at Week 16 | At Week 16 | Restricted High Risk Population comprised of a subset of the High Risk population, i.e. all those participants assigned to the High Risk stratum for randomization who met the ALP/bilirubin criteria at both Visit 2 (Day 1) and Visit 3 (Week 4). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change From Baseline at Week 16 in Serum Alanine Aminotransferase (ALT) Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population. Only those participants with data available at the specified data points were analyzed. | International Units per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Serum Aspartate Aminotransferase (AST) Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population. Only those participants with data available at the specified data points were analyzed. | International Units per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Serum Gamma Glutamyl Transferase (GGT), Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population. Only those participants with data available at the specified data points were analyzed. | International Units per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Total Bilirubin Concentration, Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population. Only those participants with data available at the specified data points were analyzed. | Micromoles per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Albumin Concentration, Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population. Only those participants with data available at the specified data points were analyzed. | Grams per Liter | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline at Week 16 in Prothrombin International Normalized Ratio (INR), Among Those With a High Risk of PBC Progression | Baseline and at Week 16 | High Risk Population. Only those participants with data available at the specified data points were analyzed. | Ratio | LEAST_SQUARES_MEAN |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group814
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | Placebo | -1.73 | 95% Confidence Interval -2.44 to -1.01 | Scores on a scale | |
| Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | GSK2330672 20 mg QD | -2.19 | 95% Confidence Interval -3.26 to -1.12 | Scores on a scale | |
| Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | GSK2330672 90 mg QD | -2.60 | 95% Confidence Interval -3.55 to -1.65 | Scores on a scale | |
| Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | GSK2330672 180 mg QD | -2.60 | 95% Confidence Interval -3.51 to -1.70 | Scores on a scale | |
| Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | GSK2330672 40 mg BID | -2.86 | 95% Confidence Interval -3.76 to -1.95 | Scores on a scale | |
| Mean Change From Baseline at Week 16 in the Mean Worst Daily Itch Score | GSK2330672 90 mg BID | -2.25 | 95% Confidence Interval -3.19 to -1.32 | Scores on a scale | |
| Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | Placebo | Symptoms | 0.2 | 95% Confidence Interval -1.0 to 1.4 | Scores on a scale |
| Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | GSK2330672 20 mg QD | Symptoms | 0.4 | 95% Confidence Interval -1.3 to 2.2 | Scores on a scale |
| Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | GSK2330672 90 mg QD | Symptoms | 0.7 | 95% Confidence Interval -0.8 to 2.3 | Scores on a scale |
| Mean Change From Baseline at Week 16 in Primary Biliary Cholangitis-40 (PBC-40) Scale | GSK2330672 180 mg QD | Symptoms | -0.9 | 95% Confidence Interval -2.4 to 0.6 | Scores on a scale |
1 to 10 of 814Source ClinicalTrials.gov
See all 814 results by groupParticipant flow54
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study Period (Up to 12 Weeks) | STARTED | Placebo | 36 | |
| Main Study Period (Up to 12 Weeks) | STARTED | GSK2330672 20 mg QD | 16 | |
| Main Study Period (Up to 12 Weeks) | STARTED | GSK2330672 90 mg QD | 23 | |
| Main Study Period (Up to 12 Weeks) | STARTED | GSK2330672 180 mg QD | 27 | |
| Main Study Period (Up to 12 Weeks) | STARTED | GSK2330672 40 mg BID | 23 | |
| Main Study Period (Up to 12 Weeks) | STARTED | GSK2330672 90 mg BID | 22 | |
| Main Study Period (Up to 12 Weeks) | COMPLETED | Placebo | 35 | |
| Main Study Period (Up to 12 Weeks) | COMPLETED | GSK2330672 20 mg QD | 16 | |
| Main Study Period (Up to 12 Weeks) | COMPLETED | GSK2330672 90 mg QD | 19 | |
| Main Study Period (Up to 12 Weeks) | COMPLETED | GSK2330672 180 mg QD | 19 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 participant flowAdverse events1,080
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 pain | Gastrointestinal disorders | Placebo - Main Study Period | 3 | 36 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | GSK2330672 20 mg QD - Main Study Period | 3 | 16 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | GSK2330672 90 mg QD - Main Study Period | 4 | 23 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | GSK2330672 180 mg QD - Main Study Period | 8 | 27 | 9 |
| other | Abdominal pain | Gastrointestinal disorders | GSK2330672 40 mg BID - Main Study Period | 2 | 23 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | GSK2330672 90 mg BID - Main Study Period | 4 | 22 | 5 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo - Final Study Period | 0 | 35 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | GSK2330672 20 mg QD - Final Study Period | 1 | 16 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | GSK2330672 90 mg QD - Final Study Period | 0 | 19 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | GSK2330672 180 mg QD - Final Study Period | 0 | 19 | 0 |
1 to 10 of 1,080Source ClinicalTrials.gov
See all 1,080 adverse eventsAdverse event totals54
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo - Main Study Period | 0 | 36 |
| Total, all-cause mortality | GSK2330672 20 mg QD - Main Study Period | 0 | 16 |
| Total, all-cause mortality | GSK2330672 90 mg QD - Main Study Period | 0 | 23 |
| Total, all-cause mortality | GSK2330672 180 mg QD - Main Study Period | 0 | 27 |
| Total, all-cause mortality | GSK2330672 40 mg BID - Main Study Period | 0 | 23 |
| Total, all-cause mortality | GSK2330672 90 mg BID - Main Study Period | 0 | 22 |
| Total, all-cause mortality | Placebo - Final Study Period | 0 | 35 |
| Total, all-cause mortality | GSK2330672 20 mg QD - Final Study Period | 0 | 16 |
| Total, all-cause mortality | GSK2330672 90 mg QD - Final Study Period | 0 | 19 |
| Total, all-cause mortality | GSK2330672 180 mg QD - Final Study Period | 0 | 19 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse event totalsPapers7
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/NCT02966834
GET https://conductscience.org/api/trials/v1/NCT02966834/registered?page=2