Chronic Hepatitis D Infection
Conditions
Brief summary
Exposure-adjusted incidence of participants with liverrelated events: hepatic decompensation (ie, ascites, jaundice, hepatic encephalopathy, portal hypertensionrelated gastro-intestinal bleeding [GIB]), hepatocellular carcinoma (HCC), liver transplantation, and liver-related death through 144 weeks of BLV treatment
Detailed description
Percentage of participants who develop cirrhosis during the study among participants who were previously noncirrhotic Percentage of participants with serious adverse events (SAEs), Grade 3 or 4 adverse events (AEs), and discontinuations due to AEs
Interventions
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exposure-adjusted incidence of participants with liverrelated events: hepatic decompensation (ie, ascites, jaundice, hepatic encephalopathy, portal hypertensionrelated gastro-intestinal bleeding [GIB]), hepatocellular carcinoma (HCC), liver transplantation, and liver-related death through 144 weeks of BLV treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of participants who develop cirrhosis during the study among participants who were previously noncirrhotic Percentage of participants with serious adverse events (SAEs), Grade 3 or 4 adverse events (AEs), and discontinuations due to AEs | — |
Countries
Austria, Belgium, France, Germany, Netherlands, Romania, Spain
Outcome results
None listed