Follow up of IFN Vs DAAs HCV SVR (IFDACS Study)

Sponsor

Humanity and Health Research Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT02578693

Collaborator

Beijing 302 Hospital (Other), Nanfang Hospital of Southern Medical University (Other), Yamanashi Prefectural Central Hospital (Other)

2,000

Enrollment

Locations

Duration (Months)

666.7

Patients Per Site

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Infection

Study Design

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Other

Official Title:

Long Term Follow-up for Subjects With Chronic Hepatitis C Infection Who Received Interferon-based Therapy or Direct-acting Antiviral Agents (DAAs)-Based Therapy

Study Start Date :

May 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Outcome Measures

Primary Outcome Measures

Sustained virological response (SVR) [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 Outcome Measures

Treatment persistence [36 months]
Treatment persistence will be the duration of treatment measured from the first dose of medication until treatment is discontinued. Reasons for premature discontinuation of treatment will be recorded.
Virological breakthrough [36 months]
The occurrence of virological breakthrough defined as an increase of HCV RNA by at least 1-log over nadir or to >100 IU if previously undetectable.
Liver disease progression [Post treatment 10 years]
Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.
Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen [Post treatment 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital	Beijing	Beijing	China	100039
2	Humanity and Health GI and Liver Centre	Hong Kong	Hong Kong	China	00852
3	Yamanashi Prefectural Central Hospital	Kofu-city	Yamanashi	Japan	400-8506