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Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension
Phase 2 trial testing Emricasan in Cirrhosis in 263 participants. Completed in 8 April 2019.
| Lead sponsor | Histogen |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 263 |
| Start date | 17 October 2016 |
| Primary completion | 2 October 2018 |
| Estimated completion | 8 April 2019 |
| Sites | 37 locations across United States, Germany, Spain |
Histogen — full company profile →
18 and older, any sex, with Cirrhosis or Portal Hypertension. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To assess the mean change from baseline to Week 24 in hepatic venous pressure gradient (HVPG)
| Group | Value | 95% CI |
|---|---|---|
| Emricasan (5 mg) | -0.48 | ± 3.356 |
| Emricasan (25 mg) | -0.81 | ± 3.669 |
| Emricasan (50 mg) | -0.70 | ± 3.400 |
| Matching Placebo | -0.18 | ± 3.028 |
To assess subjects who have at least a 20 percent reduction from baseline in HVPG
| Group | Value | 95% CI |
|---|---|---|
| Emricasan (5 mg) | 8 | |
| Emricasan (25 mg) | 14 | |
| Emricasan (50 mg) | 10 | |
| Matching Placebo | 9 |
| Group | Value | 95% CI |
|---|---|---|
| Emricasan (5 mg) | 53 | |
| Emricasan (25 mg) | 48 | |
| Emricasan (50 mg) | 46 | |
| Matching Placebo | 55 |
| Group | Value | 95% CI |
|---|---|---|
| Emricasan (5 mg) | 4 | |
| Emricasan (25 mg) | 3 | |
| Emricasan (50 mg) | 10 | |
| Matching Placebo | 3 |
To assess whether number of Caspase 3/7 biomarkers is affected by emricasan as compared to placebo
| Group | Value | 95% CI |
|---|---|---|
| Emricasan (5 mg) | -0.01 | ± 0.475 |
| Emricasan (25 mg) | -0.40 | ± 0.597 |
| Emricasan (50 mg) | -0.46 | ± 0.663 |
| Matching Placebo | -0.04 | ± 0.339 |
| Group | Value | 95% CI |
|---|---|---|
| Emricasan (5 mg) | 0.13 | ± 0.541 |
| Emricasan (25 mg) | -0.18 | ± 0.665 |
| Emricasan (50 mg) | -0.48 | ± 0.564 |
| Matching Placebo | 0.05 | ± 0.373 |
To assess whether amount of non-specific (ALT) biomarkers are affected by emricasan compared to placebo
| Group | Value | 95% CI |
|---|---|---|
| Emricasan (5 mg) | -7.83 | ± 10.650 |
| Emricasan (25 mg) | -8.06 | ± 10.542 |
| Emricasan (50 mg) | -7.06 | ± 12.010 |
| Matching Placebo | -1.69 | ± 12.907 |
| Group | Value | 95% CI |
|---|---|---|
| Emricasan (5 mg) | -6.54 | ± 11.917 |
| Emricasan (25 mg) | -4.16 | ± 9.850 |
| Emricasan (50 mg) | -5.34 | ± 11.153 |
| Matching Placebo | -2.97 | ± 12.457 |
Time frame: First day of study treatment through the follow-up phase (Week 28 for participants who received treatment through Week 24 OR Week 50 for participants who received treatment through Week 48).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Emricasan (5 mg) | Emricasan (25 mg) | Emricasan (50 mg) | Matching Placebo |
|---|---|---|---|---|---|
| Infections and infestations | Infections and infestations | — | — | — | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — | — | — | — |
| Oesophagael varices haemorrhage | Gastrointestinal disorders | — | — | — | — |
| Acute hepatic failure | Hepatobiliary disorders | — | — | — | — |
| Neoplasms | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Multi-organ failure | General disorders | — | — | — | — |
| Hepatic encephalopathy | Nervous system disorders | — | — | — | — |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Respiratory disorders | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Renal disorders | Renal and urinary disorders | — | — | — | — |
| Cardiac disorders | Cardiac disorders | — | — | — | — |
| Blood disorders | Blood and lymphatic system disorders | — | — | — | — |
| Tibial fracture | Injury, poisoning and procedural complications | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Cellulitis | Infections and infestations | — | — | — | — |
| Hepatic encephalopathy | Nervous system disorders | — | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — |
| Coombs positive haemolytic anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Splenic vein thrombosis | Blood and lymphatic system disorders | — | — | — | — |
| Acute myocardial infarction | Cardiac disorders | — | — | — | — |
| Atrial fibrillation | Cardiac disorders | — | — | — | — |
| Cardiac failure congestive | Cardiac disorders | — | — | — | — |
| Vitreous haemorrhage | Eye disorders | — | — | — | — |
| Reaction | System | Emricasan (5 mg) | Emricasan (25 mg) | Emricasan (50 mg) | Matching Placebo |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Hepatic encephalopathy | Nervous system disorders | — | — | — | — |
| Edema peripheral | General disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Hepatic encephalopathy | Nervous system disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Urinary tract infection | Infections and infestations | — | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — | — |
| Ascites | Gastrointestinal disorders | — | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Bronchitis | Infections and infestations | — | — | — | — |
| Muscle spasms | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Asthenia | General disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Influenza | Infections and infestations | — | — | — | — |
| Fall | Injury, poisoning and procedural complications | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Pruritus generalized | Skin and subcutaneous tissue disorders | — | — | — | — |
| Esophageal varices hemorrhage | Gastrointestinal disorders | — | — | — | — |
| Pyrexia | General disorders | — | — | — | — |
| Portal vein thrombosis | Hepatobiliary disorders | — | — | — | — |
| Nasopharyngitis | Infections and infestations | — | — | — | — |
| Pneumonia | Infections and infestations | — | — | — | — |
| Upper respiratory infection | Infections and infestations | — | — | — | — |
| Diabetes mellitus | Metabolism and nutrition disorders | — | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Hyperbilirubinemia | Hepatobiliary disorders | — | — | — | — |
Most-reported serious reactions: Infections and infestations, Gastrointestinal disorders, Oesophagael varices haemorrhage, Acute hepatic failure, Neoplasms, Multi-organ failure, Hepatic encephalopathy, Upper gastrointestinal haemorrhage.
Data from ClinicalTrials.gov NCT02960204 adverse events section.
This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this study). Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID, 25 mg BID, or 5 mg BID or matching placebo BID.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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