NCT01522625

Brief Summary

This study aims to clarify whether patients with chronic hepatitis B with high viral load will benefit from oral antiviral therapy despite only mildly elevated serum liver enzyme.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2012

Longer than P75 for phase_4

Geographic Reach
1 country

6 active sites

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, 2012

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

6.8 years

First QC Date

January 27, 2012

Last Update Submit

February 10, 2019

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis Bhepatitis B viral DNAantiviral therapyTenofovir

Outcome Measures

Primary Outcomes (1)

  • Severity of hepatic necroinflammation and fibrosis

    Primary outcome is the severity of necroinflammation and fibrosis in liver tissue as evaluated by Knodell and Ishak scoring system

    Within one month after completion of antiviral therapy

Secondary Outcomes (4)

  • Undetectable hepatitis B viral DNA

    Within one month after completion of antiviral therapy

  • Normalization of serum alanine aminotransferase

    Within one month after completion of antiviral therapy

  • Serum level of HBsAg

    Within one month after completion of antiviral therapy

  • Serious adverse reaction

    Within one month after completion of antiviral therapy

Study Arms (2)

TDF

EXPERIMENTAL

tenofovir disoproxil fumarate (TDF) 300mg

Drug: tenofovir disoproxil fumarate 300mg per day

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

tenofovir disoproxil fumarate 300mg per dayDRUG

tenofovir disoproxil fumarate 300mg per day for 3 years

Also known as: Viread® (Gilead Sciences Inc)
TDF
PlaceboDRUG

Placebo, identical to TDF in appearance, once daily for 3years

Placebo

Eligibility Criteria

Age25 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 25 to 70 years,
  • serum HBsAg positivity for more than 6 months,
  • positive or negative serum HBeAg,
  • serum HBV DNA more than 2,000 IU/mL,
  • highest serum ALT \> 1 fold of ULN, but \< 2 X ULN on at least two occasions (≧ 3 months apart) in the preceding one year,

You may not qualify if:

  • co-infection with HIV, HCV, or HDV,
  • previous exposure to HBV antiviral therapy for more than 12 weeks,
  • presence of cirrhosis on histopathology,
  • hepatic decompensation defined as serum bilirubin \> 2mg/dl and prolonged prothrombin time \> 3 seconds,
  • concurrent malignant diseases including hepatocellular carcinoma,
  • severe co-morbidity with life expectancy \< 1year,
  • pregnant or lactating women,
  • organ transplantation except cornea or hair transplant,
  • suspected or confirmed chronic liver diseases from etiologies other than HBV (e.g. alcoholic hepatitis, Wilson disease, Hemochromatosis…etc),
  • serum creatinine \>1.5mg/dL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Chia-Yi Christine Hospital

Chiayi City, 539, Taiwan

Location

E-Da Hospital

Kaohsiung City, 824, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 407, Taiwan

Location

Chi Mei Medical Center, Liouying

Tainan, Taiwan

Location

Mackay Memorial Hosp

Taipei, 104, Taiwan

Location

National Taiwan University Hospital Yun-Lin Branch

Yunlin, 640, Taiwan

Location

Related Publications (1)

  • Hsu YC, Chen CY, Chang IW, Chang CY, Wu CY, Lee TY, Wu MS, Bair MJ, Chen JJ, Chen CC, Tseng CH, Tai CM, Huang YT, Ku WH, Mo LR, Lin JT. Once-daily tenofovir disoproxil fumarate in treatment-naive Taiwanese patients with chronic hepatitis B and minimally raised alanine aminotransferase (TORCH-B): a multicentre, double-blind, placebo-controlled, parallel-group, randomised trial. Lancet Infect Dis. 2021 Jun;21(6):823-833. doi: 10.1016/S1473-3099(20)30692-7. Epub 2021 Jan 29.

    PMID: 33524314DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Tenofovir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Yao-Chun Hsu, MD, MSc

    E-Da Hospital, Kaohsiung, Taiwan

    PRINCIPAL INVESTIGATOR

  • Jaw-Town Lin, MD, PhD

    National Taiwan University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
superintendent

Study Record Dates

First Submitted

January 27, 2012

First Posted

January 31, 2012

Study Start

January 1, 2012

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

February 12, 2019

Record last verified: 2019-02

Locations

TW(6)