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Status unknownNCT04631640Updated Nov 17, 2020

Prognostic Model of HCV-related Disease Progression After DAAs

An observational study in HCV, sponsored by Peking University People's Hospital. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-17.

Sponsored by Peking University People's Hospital · Observational

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
234
Ages
18 Years and older
Sex
All
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Study summary

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).

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Conditions studied

  • HCV

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Keywords

  • HCV
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In context

Disease Progression

544 studies on the registry are indexed under Disease Progression; 144 are open to participants now.

This study's planned enrollment of 234 is above the median of 198 across 260 observational studies indexed under Disease Progression.

Browse Disease Progression studies →

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • lack of HCV treatment information;
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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
234 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
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What researchers measure

Primary outcomes

  1. incidence of composit liver-related events

    Composite liver outcomes, including liver-related deaths, hepatocellular carcinoma, liver decompensation, or liver transplantation.

    Time frame: through study completion, an average of 2 year

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04631640
Lead sponsor
Peking University People's Hospital
Responsible party
Liu Huixin (Assistant professor, Peking University People's Hospital) — Principal investigator
First posted
Nov 17, 2020
Start date
Dec 1, 2020 (estimated)
Primary completion
Dec 31, 2022 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Nov 17, 2020

Study contacts

Huixin Liu, Ph.D.
Contact
lhxepi@163.com
15810994780
Huixin Liu, Ph.D.
principal investigator · Peking University People's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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