NCT04631640

Brief Summary

In this study, the investigator would conduct an ambispective cohort study to build a prediction model of HCV-related disease after DAAs.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

2.1 years

First QC Date

November 11, 2020

Last Update Submit

November 15, 2020

Conditions

HCV

Keywords

HCV

Outcome Measures

Primary Outcomes (1)

  • incidence of composit liver-related events

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

    through study completion, an average of 2 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • lack of HCV treatment information;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

5 ml blood sample would taken at each follow-up, and used to test ALT, AST, ALP, AFP and HCV RNA

Study Officials

  • Huixin Liu, Ph.D.

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huixin Liu, Ph.D.

CONTACT

15810994780lhxepi@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 11, 2020

First Posted

November 17, 2020

Study Start

December 1, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2024

Last Updated

November 17, 2020

Record last verified: 2020-11