HCVNCT04631640
Prognostic Model of HCV-related Disease Progression After DAAs
An observational study of HCV, run by Peking University People's Hospital.
Trial summary
In this study, the investigator would conduct an ambispective cohort study to build a prediction model of HCV-related disease after DAAs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCV
- How many people
- 234 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 31 Dec 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: Adult patients (≥18 years old) with chronic HCV infection that were HCV RNA positive and have received DAA therapy were included, former hcv treatment information and sustained virologic response data were collected restropectively, liver-related events including liver-related deaths, HCC, liver decompensation, and liver transplantation were collected restropectively and prospectively.
Who may be able to join
- adult patients (≥18 years old) with chronic HCV infection that were HCV RNA positive;
- have received DAA treatment;
- would like to adhere to the follow-up
Who cannot join
- lack of HCV treatment information;
Trial locations and contacts
No sites are listed yet.
About this study
In this study, the investigator would conduct an ambispective cohort study to build a prediction model of HCV-related disease after DAAs.
Read the detailed description
The emergence of direct antiviral agents (DAAs) makes it possible to cure HCV, and the sustained virological response (SVR) rate is up to 90% after DAAs therapy. However, the acquisition of SVR does not mean the cure of HCV-related diseases, some patients still developed liver cirrhosis, liver cancer and other diseases after achived SVR by DAAs therapy.In this study the investigator would like to bulid a prediction model of HCV-related disease after DAAs by conducting an ambispective cohort study. The participants of this study would be adult patients (≥18 years old) with chronic HCV infection and have received DAA therapy, the investigator would retrospectively collected DAA therapy-related information, and follow-up all the enrolled participants every 6 months to observe their liver-related disease outcomes (composite liver outcome, including liver-related deaths, hepatocellular carcinoma, liver decompensation, and liver transplantation).
- Conditions
- HCV
- Keywords
- HCV
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of composit liver-related events
Composite liver outcomes, including liver-related deaths, hepatocellular carcinoma, liver decompensation, or liver transplantation.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start1 Dec 2020 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCVStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liu Huixin, Peking University People's Hospital
- Investigators
- Huixin Liu, Ph.D., Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631640
- Sponsor's protocol ID
- PHSC-1
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Model of HCV-related Disease Progression After DAAs
- ClinicalTrials.gov ID
- NCT04631640
- Acronym / sponsor ID
- PHSC-1
- Conditions
- HCV
- Keywords
- HCV
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Nov 2020 (actual)
- 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.
In this study, the investigator would conduct an ambispective cohort study to build a prediction model of HCV-related disease after DAAs.
Detailed description
The emergence of direct antiviral agents (DAAs) makes it possible to cure HCV, and the sustained virological response (SVR) rate is up to 90% after DAAs therapy. However, the acquisition of SVR does not mean the cure of HCV-related diseases, some patients still developed liver cirrhosis, liver cancer and other diseases after achived SVR by DAAs therapy.In this study the investigator would like to bulid a prediction model of HCV-related disease after DAAs by conducting an ambispective cohort study. The participants of this study would be adult patients (≥18 years old) with chronic HCV infection and have received DAA therapy, the investigator would retrospectively collected DAA therapy-related information, and follow-up all the enrolled participants every 6 months to observe their liver-related disease outcomes (composite liver outcome, including liver-related deaths, hepatocellular carcinoma, liver decompensation, and liver transplantation).
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
- Adult patients (≥18 years old) with chronic HCV infection that were HCV RNA positive and have received DAA therapy were included, former hcv treatment information and sustained virologic response data were collected restropectively, liver-related events including liver-related deaths, HCC, liver decompensation, and liver transplantation were collected restropectively and prospectively.
Key inclusion criteria (3 listed)
- adult patients (≥18 years old) with chronic HCV infection that were HCV RNA positive;
- have received DAA treatment;
- would like to adhere to the follow-up
Key exclusion criteria (1 listed)
- lack of HCV treatment information;
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
incidence of composit liver-related events
Time frame: through study completion, an average of 2 year
Composite liver outcomes, including liver-related deaths, hepatocellular carcinoma, liver decompensation, or liver transplantation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2020.
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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.
Huixin Liu, Ph.D. principal investigator
Peking University People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of HCV, run by Peking University People's Hospital.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huixin Liu, Ph.D. (15810994780, lhxepi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of composit liver-related events (time frame: through study completion, an average of 2 year). 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 17 Nov 2020.