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

NCT02578693 | Completed DMC

• 1 other identifier: H&H_HCV IFN Vs DAAs Fu
• Study Type: observational
• Target: 1,210
• Locations: 2 countries
• Sites: 3

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.

Conditions

Chronic Hepatitis C Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Treatment persistence

  36 months

• Virological breakthrough

  36 months

• Liver disease progression

  Post treatment 10 years

• Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen

  Post treatment 5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Humanity and Health Research Centre: lead
• Beijing 302 Hospital: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Yamanashi Prefectural Central Hospital: collaborator

Study Sites (3)

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital

Beijing, Beijing Municipality, 100039, China

Location

Humanity and Health GI and Liver Centre

Hong Kong, Hong Kong, 00852, China

Location

Yamanashi Prefectural Central Hospital

Kofu, Yamanashi, 400-8506, Japan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum/Plasma

Study Officials

• George Lau, MD

  Humanity & Health Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: October 19, 2015
• Study Start: May 15, 2015
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

CN (2); JP (1)