NCT02578693CompletedNot Applicable
Long Term Follow-up for Subjects With Chronic Hepatitis C Infection Who Received Interferon-based Therapy or Direct-acting Antiviral Agents (DAAs)-Based Therapy
Humanity and Health Research Centre3 sites in 2 countries1,210 target enrollmentStarted: May 15, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,210
- Locations
- 3
- Primary Endpoint
- Sustained virological response (SVR)
Study Overview
Brief Summary
The study is designed to provide long term clinical and virologic follow up in subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy. This long term follow up study is observational and no treatment is provided for HCV infection.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with chronic hepatitis C treated with interferon-based therapy or direct-acting agents (DAAs)-based regimen;
- •Provide written, informed consent;
- •Be willing and able to comply with the visit schedule and protocol-mandated procedures.
Exclusion Criteria
- •Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up time frame;
- •History of clinically significant illness or any other major medical disorder that may interfere with follow up, assessments, or compliance with the protocol.
- •Inability to provide written informed consent.
Outcomes
Primary Outcomes
Sustained virological response (SVR)
Time Frame: 36 months
The primary outcome measure is the occurence (yes or no) of sustained virologic response (SVR), defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) in serum at least 3 months after stopping therapy. Point estimates and confidence intervals will be calculated to describe the frequency of SVR in various patients receiving IFN or DAAs based treatment.
Secondary Outcomes
- Virological breakthrough(36 months)
- Liver disease progression(Post treatment 10 years)
- Treatment persistence(36 months)
- Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen(Post treatment 5 years)
Investigators
Study Sites (3)
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