A Two-year Study of Telbivudine in HBeAg Negative Hepatitis (STEN)

October 22, 2017 updated by: Chao-Shuang Lin, Third Affiliated Hospital, Sun Yat-Sen University

A Two-year, Open-label, Virological Response Adaptive Design, Multicenter Study to Evaluate Efficacy of Telbivudine in HBeAg Negative Adult CHB Patients With Roadmap Strategy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is an open-label, multicenter, PCR response adaptive clinical study design, with intensification of treatment (addition of adefovir to telbivudine treatment) depending on HBV DNA level at week 24. All patients commence with Telbivudine 600mg daily. At week 24 they will be divided into 2 Groups according to virological response. Patients with PCR detectable HBV DNA will add on ADV(Group I). Patients with PCR undetectable HBV DNA(Group II)will continue telbivudine monotherapy. ADV will not be added on unless viral breakthrough occurs.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • The Third Affiliated Hospital of Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Detectable serum HBsAg at the Screening visit and at least 6 months prior
  • HBeAg negative at Screening visit
  • serum HBV DNA level >2,000 IU/mL at Screening visit
  • Elevated serum ALT≥2 ×ULN and <10×ULN at Screening visit (excluding ALT elevations due to non-HBV reasons such as drug, alcohol etc)

Exclusion Criteria:

  • Patient has a history of clinical signs/symptoms of hepatic decompensation (Child-Pugh Grade B or C) or ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis.
  • Patient has a history of hepatocellular carcinoma (HCC) or suspected symptoms of HCC, such as suspicious foci on imaging studies and/or serum alpha-fetoprotein (AFP)>50ng/mL.
  • Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational before.
  • Patient has received IFN or other immunomodulatory treatment within 52 weeks before Screening.
  • Patient has a medical condition that requires frequent use of systemic acyclovir or famciclovir.
  • Patient has a medical condition that requires frequent use of systemic corticosteroids, however topical and inhaled corticosteroids are allowed.
  • Patient has used hepatotoxic drugs within one month.
  • Patient has overtaken alcohol (>40g/day) or abused illicit drugs in recent one year.
  • Use of other investigational drugs at the time of enrollment.
  • History of hypersensitivity to any of the study drugs (telbivudine or adefovir).
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test.
  • Patient is co-infected with HCV, HDV or HIV.
  • Patient has one or more additional known primary or secondary causes of liver disease, other than hepatitis B (e.g., alcoholism, autoimmune hepatitis).
  • History of malignancy of any organ system.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HBeAg Negative Hepatitis
HBeAg Negative Hepatitis patients.
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.
Other Names:
  • Sebivo, LDT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of patients with undectable HBV DNA
Time Frame: at Week 104
at Week 104

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Collaborators

Guangdong Provincial People's Hospital
Guangzhou 8th People's Hospital

Investigators

  • Principal Investigator: Zhi-Liang Gao, Prof, Third Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2011

Primary Completion (ACTUAL)

February 28, 2014

Study Completion (ACTUAL)

May 30, 2014

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

January 30, 2012

First Posted (ESTIMATE)

January 31, 2012

Study Record Updates

Last Update Posted (ACTUAL)

October 24, 2017

Last Update Submitted That Met QC Criteria

October 22, 2017

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HBeAg negative Roadmap

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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