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Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

NCT01341743 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2013-10-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy

Conditions

Interventions

DRUG

Entecavir

patients will receive oral entecavir 1mg, daily for 104 weeks.

DRUG

Entecavir, Adefovir

patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks

DRUG

Entecavir, Adefovir

patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks

Sponsors & Collaborators

  • JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd

    collaborator UNKNOWN

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Principal Investigators

  • JinLin Hou, MD · Nanfang Hospital, Southern Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2014-06-30
Completion
2014-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01341743 on ClinicalTrials.gov