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EFFicacy Optimization Research of Telbivudine Therapy (EFFORT)

Primary Purpose

Hepatitis B, Chronic

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
telbivudine
telbivudine
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B, Chronic focused on measuring Chronic Hepatitis B

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 302 Military Hospital of China
  • Beijing Ditan Hospita
  • Beijing Friendship Hospital Attached to the Capital Medical University
  • BeiJing YouAn Hospital ,Capital Medical University
  • Department of infectious disease, First Hospital of Peking University
  • People'S Hospital Under Beijnig University
  • The Second Affiliated of ChongQing University of Medical Science
  • Department of infectious disease, Nanfang Hospital
  • No. 8 People's Hospital In GuangZhou
  • The Third Hospital of Sun Yat-Sen University
  • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
  • Xiangya Hospital Central-South Univrsity
  • No.81 Hospital of PLA
  • First Hospital .Jilin Unniversity
  • ShengJing Hospital of China Medical University
  • JiNan Infectious Diseases Hospital
  • Changhai Hospital affiliated to Second Military Medical University
  • Huashan Hospital，Fudan University
  • No.85 Hospital of PLA
  • Shanghai Ruijin Hospital
  • Tangdu Hospital
  • West China Hospital.SiChuan University
  • The First Affiliated Hospital of College of Medicine ，Zhejiang University
  • The Sixth People's Hospital of Hangzhou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ROADMAP Group (Group I)

SOC (Standard of Care) Group (Group II)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 18, 2009
Last Updated
January 29, 2013
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Major Science and Technology Special Project of China Eleventh Five-year, Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00962533
Brief Title
EFFicacy Optimization Research of Telbivudine Therapy
Acronym
EFFORT
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Major Science and Technology Special Project of China Eleventh Five-year, Novartis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Chronic
Keywords
Chronic Hepatitis B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
606 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ROADMAP Group (Group I)
Arm Type
Experimental
Arm Description
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.
Arm Title
SOC (Standard of Care) Group (Group II)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
telbivudine
Other Intervention Name(s)
Sebivo®
Intervention Description
telbivudine, 600mg, oral, daily
Intervention Type
Drug
Intervention Name(s)
telbivudine
Other Intervention Name(s)
Sebivo®
Intervention Description
telbivudine, 600mg, oral, daily
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52
Time Frame
week 52
Title
Serum HBV DNA reduction from baseline at week 104
Time Frame
week 104
Title
Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline
Time Frame
week 104
Title
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
Title
Serum HBV DNA reduction from baseline at week 52
Time Frame
week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jinlin Hou, MD
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
302 Military Hospital of China
City
BeiJing
State/Province
Beijing
Country
China
Facility Name
Beijing Ditan Hospita
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Friendship Hospital Attached to the Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
BeiJing YouAn Hospital ,Capital Medical University
City
BeiJing
State/Province
Beijing
Country
China
Facility Name
Department of infectious disease, First Hospital of Peking University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
People'S Hospital Under Beijnig University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Second Affiliated of ChongQing University of Medical Science
City
ChongQing
State/Province
Chongqing
Country
China
Facility Name
Department of infectious disease, Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
No. 8 People's Hospital In GuangZhou
City
GuangZhou
State/Province
Guangdong
Country
China
Facility Name
The Third Hospital of Sun Yat-Sen University
City
GuangZhou
State/Province
Guangdong
Country
China
Facility Name
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Xiangya Hospital Central-South Univrsity
City
ChangSha
State/Province
Hunan
Country
China
Facility Name
No.81 Hospital of PLA
City
NanJing
State/Province
Jiangsu
Country
China
Facility Name
First Hospital .Jilin Unniversity
City
ChangChun
State/Province
Jilin
Country
China
Facility Name
ShengJing Hospital of China Medical University
City
ShenYang
State/Province
Liaoning
Country
China
Facility Name
JiNan Infectious Diseases Hospital
City
JINan
State/Province
Shandong
Country
China
Facility Name
Changhai Hospital affiliated to Second Military Medical University
City
ShangHai
State/Province
Shanghai
Country
China
Facility Name
Huashan Hospital，Fudan University
City
ShangHai
State/Province
Shanghai
Country
China
Facility Name
No.85 Hospital of PLA
City
ShangHai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Ruijin Hospital
City
ShangHai
State/Province
Shanghai
Country
China
Facility Name
Tangdu Hospital
City
XiAn
State/Province
Shanxi
Country
China
Facility Name
West China Hospital.SiChuan University
City
ChengDu
State/Province
Sichuan
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine ，Zhejiang University
City
HangZhou
State/Province
Zhejiang
Country
China
Facility Name
The Sixth People's Hospital of Hangzhou
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
17632041
Citation
Keeffe EB, Zeuzem S, Koff RS, Dieterich DT, Esteban-Mur R, Gane EJ, Jacobson IM, Lim SG, Naoumov N, Marcellin P, Piratvisuth T, Zoulim F. Report of an international workshop: Roadmap for management of patients receiving oral therapy for chronic hepatitis B. Clin Gastroenterol Hepatol. 2007 Aug;5(8):890-7. doi: 10.1016/j.cgh.2007.05.004. Epub 2007 Jul 13.
Results Reference
background
PubMed Identifier
32189364
Citation
Huang Q, Zhou B, Cai D, Zong Y, Wu Y, Liu S, Mercier A, Guo H, Hou J, Colonno R, Sun J. Rapid Turnover of Hepatitis B Virus Covalently Closed Circular DNA Indicated by Monitoring Emergence and Reversion of Signature-Mutation in Treated Chronic Hepatitis B Patients. Hepatology. 2021 Jan;73(1):41-52. doi: 10.1002/hep.31240. Epub 2020 Dec 1.
Results Reference
derived

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EFFicacy Optimization Research of Telbivudine Therapy

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