NCT02292706

A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 1,609 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this registry study is to assess the durability of sustained virologic response (SVR) and clinical progression or regression of liver disease including the incidence of hepatocellular carcinoma following SVR in participants with cirrhosis after treatment with a sofosbuvir-based regimen for HCV infection.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Exposure of interest for participants who received sofosbuvir in a previous Gilead study for chronic HCV infection.
DRUG	Ribavirin
DRUG	LDV/SOF	Exposure of interest for participants who received LDV/SOF in a previous Gilead study for chronic HCV infection.
DRUG	SOF/VEL	Exposure of interest for participants who received SOF/VEL in a previous Gilead study for chronic HCV infection.
DRUG	SOF/VEL/VOX	Exposure of interest for participants who received SOF/VEL/VOX in a previous Gilead study for chronic HCV infection.
DRUG	Other SOF-Based Regimen	The other SOF-based regimens may have included the following: * BMS-790052 (Daclatasvir) + GS-7977 (SOF) with or without RBV * LDV/SOF + GS-9669, GS-7977 (SOF) + with or without RBV + TMC-435 (Simeprevir) * LDV/SOF + Vedroprevir (VDV), LDV/SOF + GS-9669 (250 mg and 500 mg) * LDV/SOF + VDV + RBV * Simeprevir + SOF * TMC-435 (Simeprevir) + VEL/SOF
OTHER	Ineligible parent treatment	Participants were enrolled from ineligible parent treatment group.

Timeline

• Start date: 2014-12-29
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2014-11-17
• Last updated: 2023-10-04
• Results posted: 2023-10-04

Locations

138 sites across 10 countries: United States, Australia, Canada, France, Germany, Italy, New Zealand, Puerto Rico, Spain, United Kingdom