MedTrace Logo

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

NCT02292706 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 1609

Last updated 2023-10-04

Study results available
· View outcomes & findings →

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

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.

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-29
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • United States
  • Australia
  • Canada
  • France
  • Germany
  • Italy
  • New Zealand
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02292706 on ClinicalTrials.gov