EFFicacy Optimization Research of Telbivudine Therapy (EFFORT)

January 29, 2013 updated by: Nanfang Hospital of Southern Medical University

A Two-year, Randomized, Controlled, Open-label, Virologic Response Adaptive Design, Multicenter Study to Optimize Antiviral Efficacy of Telbivudine in Adult Patients With HBeAg Positive Chronic Hepatitis B (EFFORT Study)

The purpose of this trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

606

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
    • Beijing
      • BeiJing, Beijing, China
        • BeiJing YouAn Hospital ,Capital Medical University
      • BeiJing, Beijing, China
        • 302 Military Hospital of China
      • Beijing, Beijing, China
        • Beijing Ditan Hospita
      • Beijing, Beijing, China
        • Beijing Friendship Hospital Attached to the Capital Medical University
      • Beijing, Beijing, China
        • Department of infectious disease, First Hospital of Peking University
      • Beijing, Beijing, China
        • People'S Hospital Under Beijnig University
    • Chongqing
      • ChongQing, Chongqing, China
        • The Second Affiliated of ChongQing University of Medical Science
    • Guangdong
      • GuangZhou, Guangdong, China
        • No. 8 People's Hospital In GuangZhou
      • GuangZhou, Guangdong, China
        • The Third Hospital of Sun Yat-Sen University
      • Guangzhou, Guangdong, China
        • Department of Infectious Disease, Nanfang Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
    • Hunan
      • ChangSha, Hunan, China
        • Xiangya Hospital Central-South Univrsity
    • Jiangsu
      • NanJing, Jiangsu, China
        • No.81 Hospital of PLA
    • Jilin
      • ChangChun, Jilin, China
        • First Hospital .Jilin Unniversity
    • Liaoning
      • ShenYang, Liaoning, China
        • Shengjing Hospital of China Medical University
    • Shandong
      • JINan, Shandong, China
        • JiNan Infectious Diseases Hospital
    • Shanghai
      • ShangHai, Shanghai, China
        • Changhai Hospital affiliated to Second Military Medical University
      • ShangHai, Shanghai, China
        • Huashan Hospital，Fudan University
      • ShangHai, Shanghai, China
        • No.85 Hospital of PLA
      • ShangHai, Shanghai, China
        • Shanghai Ruijin Hospital
    • Shanxi
      • XiAn, Shanxi, China
        • Tangdu Hospital
    • Sichuan
      • ChengDu, Sichuan, China
        • West China Hospital.SiChuan University
    • Zhejiang
      • HangZhou, Zhejiang, China
        • The First Affiliated Hospital of College of Medicine ，Zhejiang University
      • Hangzhou, Zhejiang, China
        • The Sixth People's Hospital of Hangzhou

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:

  • Male or female, from 18 (inclusive) to 65 (inclusive) years of age
  • HBsAg and HBeAg positive for over six months
  • Patient is willing and able to comply with the study drug regimen and all other study requirements
  • Patients must give written informed consent before any assessment is performed

Exclusion Criteria:

  • Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit
  • Patient has a history of or clinical signs/symptoms of hepatic decompensation
  • Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC
  • Other protocol-defined inclusion/exclusion criteria may apply

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ROADMAP Group (Group I)

Patients were to take telbivudine 600 mg orally daily from Baseline.At Week 24, patients in Group I were split into Group I-A or Group I-B based on their virologic load:

  • Group I-A: This group of patients was those with HBV DNA ≥300 copies/mL at Week 24 and adefovir was to be added at Week 28;
  • Group I-B: This group of patients was those with HBV DNA <300 copies/mL at Week 24. Telbivudine monotherapy was to be continued until there was a viral breakthrough (confirmed by two examinations with at least 1 month interval with compliance factor excluded) and then adefovir was to be added;

The total treatment duration was 104 weeks.
Drug: telbivudine
telbivudine, 600mg, oral, daily
Other Names:
  • Sebivo®
ACTIVE_COMPARATOR: SOC (Standard of Care) Group (Group II)
patients were to take telbivudine 600 mg monotherapy from Baseline until Week 104. If viral breakthrough (defined as HBV DNA 1 log10 above nadir) was confirmed (by two examinations with at least a 1 month interval with compliance factor excluded), adefovir 10 mg daily was to be added.
Drug: telbivudine
telbivudine, 600mg, oral, daily
Other Names:
  • Sebivo®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II
Time Frame: Week 104
Week 104

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52
Time Frame: week 52
week 52
Serum HBV DNA reduction from baseline at week 104
Time Frame: week 104
week 104
Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline
Time Frame: week 104
week 104
Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline
Time Frame: week 104
week 104
Serum HBV DNA reduction from baseline at week 52
Time Frame: week 52
week 52

Collaborators and Investigators

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

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Novartis
Major Science and Technology Special Project of China Eleventh Five-year

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

August 1, 2009

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

August 1, 2012

Study Registration Dates

First Submitted

August 18, 2009

First Submitted That Met QC Criteria

August 19, 2009

First Posted (ESTIMATE)

August 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 29, 2013

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOH-01

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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