The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time. Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
723
Intervention of interest; follow-up after ALV-active study
Novartis Investigative Site
La Jolla, California, United States
Novartis Investigative Site
San Diego, California, United States
Novartis Investigative Site
Ventura, California, United States
Novartis Investigative Site
Bradenton, Florida, United States
Novartis Investigative Site
Honolulu, Hawaii, United States
Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48
Time frame: up to 120 Weeks
Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48.
Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir.
Time frame: at Week 48
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Novartis Investigative Site
Springfield, Illinois, United States
Novartis Investigative Site
Indianapolis, Indiana, United States
Novartis Investigative Site
Arlington, Texas, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
...and 109 more locations