NCT01148576

Brief Summary

To investigate the influence of hepatic steatosis on the anti-viral effect of entecavir in chronic hepatitis B patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

1.5 years

First QC Date

June 17, 2010

Last Update Submit

June 21, 2010

Conditions

Chronic Hepatitis BHepatic Steatosis

Keywords

hepatic steatosis, chronic hepatitis B, entecavir

Outcome Measures

Primary Outcomes (1)

  • Differences in the anti-viral effect of entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs

    The common measurement includes serum biochemistry markers (ALT, AST, GGT, CRP, PT, APTT, AMA, UA, Chol, TG, TB, DB, ALP, fasting glucose, insulin, et al), virus markers (HBs-Ag, Hbe-Ag, anti-HBc-Ab, HBV genotype, HBV- DNA copy, YMDD variation, et al), Liver CT scan or ultrasound (steatosis degree and fibrosis and changes in the histological features of liver biopsy(steatosis degree, inflammation and fibrosis).

    12 months

Secondary Outcomes (2)

  • Differences in the sustained response rate to entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs and obtained anti-virus effect after 1 year treatment.

    15 months

  • Differences in the anti-viral effect of entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs in a short term.

    3 months

Study Arms (4)

control group

OTHER

patients only with chronic hepatitis B

Drug: entecavir

model group

ACTIVE COMPARATOR

patients with chronic hepatitis B and hepatic steatosis

Drug: entecavir

Essentiale group

EXPERIMENTAL

patients with chronic hepatitis B and hepatic steatosis

Drug: essentiale + entecavir

treatment group 2

EXPERIMENTAL

patients with chronic hepatitis B and hepatic steatosis

Drug: Vitamin E + entecavir

Interventions

entecavirDRUG

entecavir 0.5 mg qd for 12 months

control group
essentiale + entecavirDRUG

entecavir 0.5 mg qd for 12 months，Essentiale 2 tablets tid in the first 3 months and 1 tablets tid in the rest 9 months

Essentiale group
Vitamin E + entecavirDRUG

entecavir 0.5 mg qd for 12 months, Vitamin E: 100 mg bid for 12 months

treatment group 2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients should be diagnosed with chronic hepatitis B infection and hepatic steatosis
  • CHB infection
  • HBV-DNA ≥ 1×105 copies/ml；
  • HBeAg positive ；
  • ALT between the 2-10 times of the upper limit level
  • hepatic steatosis According to the "Guidelines for the assessment and management of non-alcoholic fatty liver disease in the Asia-Pacific region: executive summary", with test of CT scan or B ultrasound and confirmation of liver biopsy(in portion of patients)

You may not qualify if:

  • those receiving antiviral treatment before the study
  • those on hepatoxic drug treatment,
  • those consuming alcohol regularly or excessively,
  • those diagnosed of cirrhosis, anti-HCV or anti-Delta positive patients,
  • those diagnosed as having autoimmune or other metabolic liver diseases
  • those have wilson's disease, PBC, PSC, IBD and other diseases that may influence the process and effect of therapy
  • those who are pregnant, have mental disorder and were received anti-viral treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital, college of medicine, zhejiang university

Hangzhou, Zhejaing, 310003, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, ChronicFatty Liver

Interventions

entecaviressential 303 forteVitamin E

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)

BenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Xi Jin, phD

CONTACT

0086-571-87266532jxfl007@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2010

First Posted

June 22, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2011

Study Completion

February 1, 2012

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations

CN(1)