NCT02308319

Brief Summary

Antiviral therapy for HBV may play an important role here, as a large observation study from Taiwan reported that the use of nucleos(t)ide analogues (NUC) was associated with 33% reduction in HCC recurrence. In the first randomized controlled trial evaluating the use of NUC after surgical resection for HCC, NUC therapy was associated with better 2-year overall (94% vs. 62%) and recurrence-free (56% vs. 20%) survival. However, patients with active liver disease should be treated regardless of their impact on HCC recurrence (patients with high serum HBV DNA and abnormal ALT). What is less clear is that whether patients with low level HBV DNA, and normal serum ALT levels should be treated to reduce HCC recurrence. In this trial, we will investigate to determine the efficacy of the treatment with Tenofovir disoproxil fumarate (Viread(R)) as measured by the cumulative incidence rate of hepatocellular carcinoma (HCC) at 3 year after curative treatment with radiofrequency ablation (RFA) or surgical resection (SR) in chronic hepatitis B virus (HBV) infected patients with low viral load.

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
124

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_4

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 26, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

December 4, 2014

Status Verified

November 1, 2014

Enrollment Period

3.9 years

First QC Date

November 26, 2014

Last Update Submit

December 2, 2014

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular carcinoma, Recurrence

Outcome Measures

Primary Outcomes (1)

  • Recurrence free survival

    3 years

Secondary Outcomes (4)

  • Overall survival

    3 years

  • New onset ascites, variceal bleeding, hepatic encephalopathy

    3 years

  • Child-Pugh score and MELD score at baseline and at final follow-up

    3 years

  • Reactivation of hepatitis B

    3 years

Study Arms (2)

PROMPT

ACTIVE COMPARATOR

Prompt therapy with Tenofovir disoproxil fumarate (Viread(R)) 300mg p.o

Drug: Tenofovir disoproxil fumarate

Watchful monitoring

OTHER

Wait and treat with Tenofovir disoproxil fumarate (Viread(R)) when active liver disease is present \[defined as HBV DNA \>2,000 IU/ml and abnormal ALT (\>40 IU/ml)\]

Drug: Tenofovir disoproxil fumarate

Interventions

Tenofovir disoproxil fumarateDRUG

300mg q.d. per oral

Also known as: Viread(R)
PROMPTWatchful monitoring

Eligibility Criteria

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

You may qualify if:

  • Hepatocellular carcinoma (clinically or histologically)
  • chronic hepatitis B
  • serum HBV DNA \< 2000 IU/mL
  • HCC stage BCLC 0 or A
  • treated or will be treated with RFA or surgical resection

You may not qualify if:

  • co-infected with HCV, HIV
  • currently using antiviral drug (lamivudine, adefovir, clevudine, tenofovir, entecavir, telbivudine) or interferon
  • other malignancy
  • dialysis
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Carcinoma, HepatocellularRecurrence

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Seung Woon Paik, M.D., Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung Woon Paik, M.D., Ph.D.

CONTACT

82-2-3410-3409sw.paik@samsung.com

Dong Hyun Sinn, M.D., Ph.D.

CONTACT

82-2-3410-3012dh.sinn@samsung.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2014

First Posted

December 4, 2014

Study Start

January 1, 2015

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

December 4, 2014

Record last verified: 2014-11