Chronic Hepatitis C InfectionNCT02578693
Follow up of IFN Vs DAAs HCV SVR (IFDACS Study)
An observational study of Chronic Hepatitis C Infection, run by Humanity and Health Research Centre at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C Infection
- How many people
- 1,210 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 May 2015to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites
Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
Beijing, Beijing Municipality, 100039
Humanity and Health GI and Liver Centre
Hong Kong, Hong Kong, 00852
About this study
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
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Secondary outcomes (4)
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.
Measured: 36 months
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.
Measured: 36 months
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 α-fetoprotein) and observed or reported clinical signs and symptoms.
Measured: Post treatment 10 years
Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen
Measured: Post treatment 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study start15 May 2015
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis C InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Humanity and Health Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing 302 Hospital, Nanfang Hospital, Southern Medical University, Yamanashi Prefectural Central Hospital
- Responsible party
- Sponsor
- Investigators
- George Lau, MD, Principal investigator, Humanity & Health Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578693
- Sponsor's protocol ID
- H&H_HCV IFN Vs DAAs Fu
- Status last verified
- Mar 2025
- First submitted
- 16 Oct 2015
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02578693
- Acronym / sponsor ID
- H&H_HCV IFN Vs DAAs Fu
- Conditions
- Chronic Hepatitis C Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,210 participants (actual)
- Lead sponsor
- Humanity and Health Research CentreUniversity, hospital or other
- Collaborators
- Beijing 302 Hospital, Nanfang Hospital, Southern Medical University, Yamanashi Prefectural Central Hospital
- Study start
- 15 May 2015 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Treatment persistence
Time frame: 36 months
Virological breakthrough
Time frame: 36 months
Liver disease progression
Time frame: Post treatment 10 years
Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen
Time frame: Post treatment 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Lau, MD principal investigator
Humanity & Health Medical Centre
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis C Infection, run by Humanity and Health Research Centre at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained virological response (SVR) (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.