NCT04173520

Brief Summary

aimed to develop a scoring system to assess risk of developing HCC in a large cohort of chronic hepatitis C (CHC) patients with advanced hepatic fibrosis (F3) or cirrhosis (F4) with sustained virological response (SVR) after receiving direct acting antivirals (DAAs).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,326

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

January 1, 2015

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

4.6 years

First QC Date

November 17, 2019

Last Update Submit

November 22, 2019

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

  • Rate of HCC incidence after viral clearance

    12-45 months after SVR

Interventions

DDADRUG

Follow up after SVR

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

2326 CHC patients (638 patients with F3 and 1734 with F4 stage)

You may qualify if:

  • no history of previous HCC
  • SVR after DAAs treatment

You may not qualify if:

  • history of previous HCC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

bis(p-chlorophenyl)acetic acid

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2019

First Posted

November 22, 2019

Study Start

January 1, 2015

Primary Completion

August 1, 2019

Study Completion

October 30, 2019

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share