A Registry for Cirrhosis that has a Sustained Virologic Response Following Sofosbuvir-Based Treatment without Interferon, for Patients who have Chronic Hepatitis C Infection

Overview

About this study

The purpose of this registry is to enroll patients who have cirrhosis with a sustained viral response after receiving a sofosbuvir-based treatment without interferon, either while participating in a Gilead-sponsored hepatitis C virus study or commercially at selected sites. Once enrolled, the patients will be followed for up to 5 years.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

Willing and able to provide written informed consent
Has either previously participated in a Gilead-sponsored HCV study (or at pre-selected sites only) and received
- A sofosbuvir-containing regimen without interferon
  - Must achieve SVR as defined in the treatment protocol
  - Has liver cirrhosis, as defined in the treatment protocol
  - Has not had a liver transplant after receiving a SOF-containing regimen
- An all-oral SOF-based regimen (outside a clinical study)
  - Must have documentation of the regimen, start and end of treatment dates (month and year), and of having achieved SVR12
  - SVR will be defined as HCV RNA < LLOQ approximately 12 weeks following last dose of treatment
  - Will have had cirrhosis confirmed prior to initiation of HCV treatment

Exclusion Criteria

Planning to initiate a new course of HCV therapy, including approved products and any investigational agents, during the course of this Registry
History of clinically-significant illness or any other major medical disorder that may interfere with the follow-up, assessments, or compliance with the protocol

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Kymberly Watt, M.D.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Kymberly Watt, M.D.

Closed for enrollment

More information

Publications

Hepatocellular carcinoma (HCC) is the leading cause of death in patients with chronic hepatitis. In this international collaboration, we sought to develop a global universal HCC risk score to predict the HCC development for patients with chronic hepatitis. Read More on PubMed

Clinical Trials