NCT02785874

Brief Summary

Statin is a preventive medicine for hepatitis B and hepatitis C which decreases the risk turning into liver cancer,however, the investigators also discovered that patients taking Statin live longer than patients who didn't take Statin in the incidence of liver cancer death cases.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

May 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

April 19, 2017

Status Verified

May 1, 2016

Enrollment Period

1 month

First QC Date

May 25, 2016

Last Update Submit

April 18, 2017

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    Up to two year

Study Arms (2)

Statin(Crestor) taken

EXPERIMENTAL

Subjects take Statin(Crestor) 10mg per day for a- year

Drug: Statin

non Statin(Crestor) taken

NO INTERVENTION

non Statin(Crestor) taken as a reference for experimental group.

Interventions

StatinDRUG

Divide HCC patients into two groups under randomization, one is with Statin and the other is without Statin to verify whether Statin could prolong disease-free survival

Statin(Crestor) taken

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>20 years old.
  • BCLC stage B , stage C and stage D

You may not qualify if:

  • Cancer diagnosis before HCC was confirmed and incurable.
  • \<20 years old, \> 90years old.
  • Patients who are judged to be ineligible for study entry by the investigator or subinvestigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WanFangHospital

Taipei, 116, Taiwan

Location

MeSH Terms

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Intervention Hierarchy (Ancestors)

Anticholesteremic AgentsHypolipidemic AgentsAntimetabolitesMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesEnzyme InhibitorsLipid Regulating AgentsTherapeutic Uses

Study Officials

  • Ming Shun Wu, Doctor

    WanFangHospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

May 30, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

April 19, 2017

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)