Trial · NCT02177136
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | DB Phase: Change From Baseline In Serum Alkaline Phosphatase (ALP) | Baseline, Week 24 | The primary efficacy analysis compared the Week 24 change from Baseline in ALP between OCA treatment group and placebo using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and randomization strata, and Baseline as a covariate. Results are reported in U/L. |
| Primary | LTSE Phase: Incidence Of Adverse Events Of Special Interest (AESIs) | LTSE Baseline (DB Week 24) to Month 26 | The primary safety analysis evaluated the effects of OCA treatment on AESIs of pruritus, hepatic disorders, and dyslipidemia. All adverse event (AE) summaries were restricted to treatment emergent AEs (TEAEs), which were defined as any AEs that newly appeared, increased in frequency, or worsened in severity following initiation of investigational product. Treatment-emergent pruritus was defined as any preferred term (PT) including "Prur-". Hepatic disorder AESIs were defined using specific Hepatic Disorders Standardized Medical Dictionary for Regulatory Activities (MedDRA) Query (SMQ) terms. AE lipid profile changes, defined in the Dyslipidemia SMQ, were reported. Verbatim terms were mapped to PTs and system organ classes (SOCs) using MedDRA version 17.1 for all AE summaries except those for hepatic disorder AESIs, which used MedDRA version 18.1. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. |
| Secondary | DB Phase: Change From Baseline In Serum Alanine Transaminase (ALT) | Baseline, Week 24 | As a marker of hepatic biochemistry and liver function, the median change in ALT from Baseline at Week 24 is reported. Results are reported in U/L. |
| Secondary | DB Phase: Change From Baseline In Serum Aspartate Aminotransferase (AST) | Baseline, Week 24 | As a marker of hepatic biochemistry and liver function, the median change in AST from Baseline at Week 24 is reported. Results are reported in U/L. |
| Secondary | DB Phase: Change From Baseline In Serum Total Bilirubin | Baseline, Week 24 | As a marker of hepatic biochemistry and liver function, the median change in serum total bilirubin from Baseline at Week 24 is reported. Results are reported in umol/L. |
| Secondary | DB Phase: Change From Baseline In Serum Direct Bilirubin | Baseline, Week 24 | As a marker of hepatic biochemistry and liver function, the median change in serum direct bilirubin from Baseline at Week 24 is reported. Results are reported in umol/L. |
| Secondary | DB Phase: Change From Baseline In Serum Gamma-glutamyl Transferase (GGT) | Baseline, Week 24 | As a marker of hepatic biochemistry and liver function, the median change in serum GGT from Baseline at Week 24 is reported. Results are reported in U/L. |
| Secondary | DB Phase: Change From Baseline In Plasma Fibroblast Growth Factor-19 (FGF-19) | Baseline, Week 24 | To assess farnesoid X receptor (FXR) activity, the change in FGF-19 from Baseline at Week 24 is reported. Results are reported in picograms/milliliter (pg/mL). |
| Secondary | DB Phase: Change From Baseline In Plasma 7α-Hydroxy-4-cholesten-3-one (C4) | Baseline, Week 24 | To assess FXR activity, the change in plasma C4 from Baseline at Week 24 is reported. Results are reported in nanograms (ng)/mL. |
| Secondary | LTSE Phase: Change From Baseline In Serum ALP At Month 12 | LTSE Baseline (DB Week 24), Month 12 | The median change in serum ALP from Baseline to the last available visit is reported. The DB value at Week 24 was used as the Baseline. Results are reported in U/L. |
| Secondary | LTSE Phase: Change From Baseline In Serum ALT At Month 12 | LTSE Baseline (DB Week 24), Month 12 | As a marker of hepatic biochemistry and liver function, the median change in ALT from Baseline at Month 12 is reported. The DB value at Week 24 was used as the Baseline. Results are reported in U/L. |
| Secondary | LTSE Phase: Change From Baseline In Serum AST At Month 12 | LTSE Baseline (DB Week 24), Month 12 | As a marker of hepatic biochemistry and liver function, the median change in AST from Baseline at Month 12 is reported. The DB value at Week 24 was used as the Baseline. Results are reported in U/L. |
| Secondary | LTSE Phase: Change From Baseline In Serum Total Bilirubin At Month 12 | LTSE Baseline (DB Week 24), Month 12 | As a marker of hepatic biochemistry and liver function, the median change in serum total bilirubin from Baseline at Month 12 is reported. The DB value at Week 24 was used as the Baseline. Results are reported in umol/L. |
| Secondary | LTSE Phase: Change From Baseline In Serum Direct Bilirubin At Month 12 | LTSE Baseline (DB Week 24), Month 12 | As a marker of hepatic biochemistry and liver function, the median change in serum direct bilirubin from Baseline at Month 12 is reported. The DB value at Week 24 was used as the Baseline. Results are reported in umol/L. |
| Secondary | LTSE Phase: Change From Baseline In Serum GGT At Month 12 | LTSE Baseline (DB Week 24), Month 12 | As a marker of hepatic biochemistry and liver function, the median change in serum GGT from Baseline at Month 12 is reported. The DB value at Week 24 was used as the Baseline. Results are reported in U/L. |
| Secondary | LTSE Phase: Change From Baseline In Albumin At Month 12 | LTSE Baseline (DB Week 24), Month 12 | As a marker of hepatic biochemistry and liver function, the median change in albumin from Baseline at Month 12 is reported. The DB value at Week 24 was used as the Baseline. Results are reported in grams (g)/L. |
| Secondary | LTSE Phase: Change From Baseline In INR At Month 12 | LTSE Baseline (DB Week 24), Month 12 | As a marker of hepatic biochemistry and liver function, the median change in INR from Baseline at Month 12 is reported. The DB value at Week 24 was used as the Baseline. |
| Secondary | LTSE Phase: Change From Baseline In Transient Elastography (TE) At Month 12 | LTSE Baseline (DB Week 24), Month 12 | As a marker of hepatic inflammation and fibrosis, the median change in TE, as a measure of hepatic stiffness, from Baseline at Month 12 is reported. The DB value at Week 24 was used as the Baseline. Results are reported in kilopascal (kPa). |
| Secondary | LTSE Phase: Change From Baseline In Enhanced Liver Fibrosis (ELF) At Month 12 | LTSE Baseline (DB Week 24), Month 12 | As a marker of hepatic inflammation and fibrosis, the change in ELF score from Baseline at Month 12 is reported. The ELF score and its components (hyaluronic acid \[HA\]; procollagen-3 N-terminal peptide \[P3NP\]; tissue inhibitor of metalloproteinase 1 \[TIMP-1\]) was calculated as follows: 2.278 + 0.851 x ln(HA (ng/mL)) + 0.751 x ln(P3NP (ng/mL)) + 0.394 x ln(TIMP-1 (ng/mL). The DB value at Week 24 was used as the Baseline. An increase in score indicates an improvement/worsening of symptoms. |
| Secondary | LTSE Phase: Change From Baseline In Plasma FGF-19 At Month 12 | LTSE Baseline (DB Week 24), Month 12 | To assess FXR activity, the change in FGF-19 from Baseline at Month 12 is reported. The DB value at Week 24 was used as the Baseline. Results are reported in pg/mL. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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