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Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)
Phase 2 trial testing Placebo in Liver Cirrhosis, Biliary in 60 participants. Completed in 25 September 2017.
| Lead sponsor | Intercept Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 60 |
| Start date | 17 January 2008 |
| Primary completion | 21 September 2010 |
| Estimated completion | 25 September 2017 |
| Sites | 21 locations across France, Austria, United Kingdom, Germany, Canada, United States, Spain |
Intercept Pharmaceuticals — full company profile →
Adults 18 to 70, any sex, with Liver Cirrhosis, Biliary. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The percent change in serum ALP from baseline to Day 85 is reported. The baseline value used was the mean of the pretreatment Screening and Day 0 evaluations.
| Group | Value | 95% CI |
|---|---|---|
| DB OCA 10 mg | -44.5 | ± 24.4 |
| DB OCA 50 mg | -37.6 | ± 21.0 |
| DB OCA Placebo | 0.4 | ± 15.3 |
As a marker of hepatocellular injury and liver function, the percent change in GGT from baseline to Day 85 is reported.
| Group | Value | 95% CI |
|---|---|---|
| DB OCA 10 mg | -73 | ± 18 |
| DB OCA 50 mg | -65 | ± 25 |
| DB OCA Placebo | -3 | ± 22 |
As a marker of hepatocellular injury and liver function, the percent change in ALT from baseline to Day 85 is reported.
| Group | Value | 95% CI |
|---|---|---|
| DB OCA 10 mg | -37 | ± 35 |
| DB OCA 50 mg | -35 | ± 25 |
| DB OCA Placebo | -4 | ± 40 |
As a marker of hepatocellular injury and liver function, the percent change in conjugated bilirubin from baseline to Day 85 is reported.
| Group | Value | 95% CI |
|---|---|---|
| DB OCA 10 mg | 0.7 | ± 67.3 |
| DB OCA 50 mg | -1.7 | ± 39.9 |
| DB OCA Placebo | 30.3 | ± 69.8 |
The percent change in serum ALP from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | -43.1 | -61.3 – -20.2 |
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | -44.4 | -65.5 – -18.6 |
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | -33.4 | -64.5 – -17.9 |
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | -31.8 | -57.5 – -14.0 |
The percent change in serum ALP from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | -38.8 | ± 29.7 |
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | -39.3 | ± 36.6 |
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | -31.7 | ± 57.3 |
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | -30.4 | ± 36.6 |
As a marker of hepatocellular injury and liver function, the percent change in GGT from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | -71.1 | -84.3 – -33.8 |
As a marker of hepatocellular injury and liver function, the percent change in GGT from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | -55.6 | ± 41.4 |
As a marker of hepatocellular injury and liver function, the percent change in ALT from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | -52.2 | -68.4 – -11.6 |
As a marker of hepatocellular injury and liver function, the percent change in ALT from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | -39.6 | ± 42.8 |
As a marker of hepatocellular injury and liver function, the percent change in conjugated bilirubin from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | 33.3 | -11.1 – 100.0 |
As a marker of hepatocellular injury and liver function, the percent change in conjugated bilirubin from baseline to the last available visit is reported. The DB baseline value was used as the baseline.
| Group | Value | 95% CI |
|---|---|---|
| LTSE OCA Total | 57.8 | ± 103.0 |
Time frame: DB Phase: Adverse events were collected starting when the participant took the first dose of study medication (following Day 0) and during study participation, through the follow-up visit at Month 3. LSTE Phase: Baseline (DB Month 3) up to 96 months.. Reporting threshold: 4.99%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | DB OCA 10 mg | DB OCA 50 mg | DB OCA Placebo | LTSE OCA Total |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — | — | — |
| Peripheral ischaemia | Vascular disorders | — | — | — | — |
| Lung neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Uterine prolapse | Reproductive system and breast disorders | — | — | — | — |
| Cystocele | Reproductive system and breast disorders | — | — | — | — |
| Pelvic fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Hip fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Bradycardia | Cardiac disorders | — | — | — | — |
| Atrial flutter | Cardiac disorders | — | — | — | — |
| Tricuspid valve incompetence | Cardiac disorders | — | — | — | — |
| Pericarditis | Cardiac disorders | — | — | — | — |
| Haemorrhagic anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Transient ischaemic attack | Nervous system disorders | — | — | — | — |
| Vertigo | Ear and labyrinth disorders | — | — | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — | — |
| Gastric varices haemorrhage | Gastrointestinal disorders | — | — | — | — |
| Bile duct stone | Hepatobiliary disorders | — | — | — | — |
| Jaundice | Hepatobiliary disorders | — | — | — | — |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Polyarthritis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Reaction | System | DB OCA 10 mg | DB OCA 50 mg | DB OCA Placebo | LTSE OCA Total |
|---|---|---|---|---|---|
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — |
| Oedema peripheral | General disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — |
| Sinusitis | Infections and infestations | — | — | — | — |
| Vitamin D deficiency | Metabolism and nutrition disorders | — | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | — | — | — | — |
| Haemorrhoids | Gastrointestinal disorders | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — |
| Muscle spasm | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Abdominal discomfort | Gastrointestinal disorders | — | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — |
| Diverticulum | Gastrointestinal disorders | — | — | — | — |
| Cystitis | Infections and infestations | — | — | — | — |
| Contusion | Injury, poisoning and procedural complications | — | — | — | — |
| Procedural pain | Injury, poisoning and procedural complications | — | — | — | — |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Eczema | Skin and subcutaneous tissue disorders | — | — | — | — |
| Influenza like illness | General disorders | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
Most-reported serious reactions: Abdominal pain, Rash, Peripheral ischaemia, Lung neoplasm, Uterine prolapse, Cystocele, Pelvic fracture, Hip fracture.
Data from ClinicalTrials.gov NCT00570765 adverse events section.
The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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