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A Two-year Study of Telbivudine in HBeAg Negative Hepatitis

NCT01521975 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2017-10-24

No results posted yet for this study

Summary

Based on GLOBE study supplying predictability analysis results, ROADMAP strategy provides an individualized telbivudine treatment roadmap strategy designed to achieve optimal viral suppression and low resistance rate in patients with chronic hepatitis B(CHB), which includes adding ADV treatment at different time points according to individual patient response. China CHB Guidelines (China Medical Association 2010) make impress on and confirm LDT ROADMAP strategy particularly, which may be a large potential to expand the naïve patients. We are lack of optimal model in HBeAg(-). In China HBeAg(-) is around 38% of total CHB patients. In GLOBE study, LdT treatment against HBeAg(-) patients with HBV DNA \<7log showed a good 2 year efficacy, but we still look forward to more efficient treatment and lower resistance rate. This study complies with the principle of individualized therapy recommended and ethical principles. It is expected that this study design with individualized treatment approach may improve efficacy and lower the resistance rates. In addition, it will provide important information on how to bring greater benefits to patients with CHB.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

Telbivudine, Adefovir dipivoxil

All patients will take Telbivudine 600 mg PO daily from baseline. Some patients will take Adefovir dipivoxil 10 mg PO daily if they meet the criteria of adding Adefovir dipivoxil.

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    collaborator OTHER

  • Guangzhou 8th People's Hospital

    collaborator OTHER

  • Third Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Zhi-Liang Gao, Prof · Third Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2011-01-01
Primary Completion
2014-02-28
Completion
2014-05-30

Countries

  • China

Study Locations

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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 NCT01521975 on ClinicalTrials.gov