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

Chronic Hepatitis C Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02578693
• Other study ID #: H&H_HCV IFN Vs DAAs Fu
• Status: Recruiting
• Start date: May 2015
• Est. completion date: June 2024

Study information

• Verified date: December 2022
• Source: Humanity and Health Research Centre
• Contact: Yudong WANG, PhD
• Phone: +85228613777
• Email: danny.wang[@]hnhmgl.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infections

Locations

Country	Name	City	State
China	Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital	Beijing	Beijing
China	Humanity and Health GI and Liver Centre	Hong Kong	Hong Kong
Japan	Yamanashi Prefectural Central Hospital	Kofu-city	Yamanashi

Sponsors (4)

Lead Sponsor	Collaborator
Humanity and Health Research Centre	Beijing 302 Hospital, Nanfang Hospital of Southern Medical University, Yamanashi Prefectural Central Hospital

Countries where clinical trial is conducted

China,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response (SVR)	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.	36 months
Secondary	Treatment persistence	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.	36 months
Secondary	Virological breakthrough	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.	36 months
Secondary	Liver disease progression	Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and a-fetoprotein) and observed or reported clinical signs and symptoms.	Post treatment 10 years
Secondary	Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen		Post treatment 5 years