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EFFicacy Optimization Research of Telbivudine Therapy (EFFORT)

This study has been completed.
Sponsor:
Collaborators:
Major Science and Technology Special Project of China Eleventh Five-year
Novartis
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT00962533
First received: August 18, 2009
Last updated: January 29, 2013
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Hepatitis B, Chronic
Drug: telbivudine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Nanfang Hospital of Southern Medical University:

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 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Serum HBV DNA reduction from baseline at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Serum HBV DNA reduction from baseline at week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]

Enrollment: 606
Study Start Date: August 2009
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Sebivo®

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962533

Locations
China, Beijing
302 Military Hospital of China
BeiJing, Beijing, China
BeiJing YouAn Hospital ,Capital Medical University
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
Beijing, Beijing, China
China, Chongqing
The Second Affiliated of ChongQing University of Medical Science
ChongQing, Chongqing, China
China, Guangdong
The Third Hospital of Sun Yat-Sen University
GuangZhou, Guangdong, China
No. 8 People's Hospital In GuangZhou
GuangZhou, Guangdong, China
Department of infectious disease, Nanfang Hospital
Guangzhou, Guangdong, China
China, Hubei
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
China, Hunan
Xiangya Hospital Central-South Univrsity
ChangSha, Hunan, China
China, Jiangsu
No.81 Hospital of PLA
NanJing, Jiangsu, China
China, Jilin
First Hospital .Jilin Unniversity
ChangChun, Jilin, China
China, Liaoning
ShengJing Hospital of China Medical University
ShenYang, Liaoning, China
China, Shandong
JiNan Infectious Diseases Hospital
JINan, Shandong, China
China, Shanghai
Shanghai Ruijin Hospital
ShangHai, Shanghai, China
Huashan Hospital,Fudan University
ShangHai, Shanghai, China
No.85 Hospital of PLA
ShangHai, Shanghai, China
Changhai Hospital affiliated to Second Military Medical University
ShangHai, Shanghai, China
China, Shanxi
Tangdu Hospital
XiAn, Shanxi, China
China, Sichuan
West China Hospital.SiChuan University
ChengDu, Sichuan, China
China, Zhejiang
The First Affiliated Hospital of College of Medicine ,Zhejiang University
HangZhou, Zhejiang, China
The Sixth People's Hospital of Hangzhou
Hangzhou, Zhejiang, China
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Major Science and Technology Special Project of China Eleventh Five-year
Novartis
Investigators
Principal Investigator: Jinlin Hou, MD Nanfang Hospital of Southern Medical University
  More Information

Publications:
Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT00962533     History of Changes
Other Study ID Numbers: MOH-01
Study First Received: August 18, 2009
Last Updated: January 29, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Nanfang Hospital of Southern Medical University:
Chronic Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
DNA Virus Infections
Digestive System Diseases
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Telbivudine
Anti-Infective Agents
Antiviral Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014