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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02578693
Other study ID # H&H_HCV IFN Vs DAAs Fu
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
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