Clinical trial NCT00962533: EFFicacy Optimization Research of Telbivudine Therapy
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Keywords: Chronic Hepatitis B
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Major Science and Technology Special Project of China Eleventh Five-year
name: Novartis
First posted: 2009-08-20
Enrollment: 606
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II
timeFrame: Week 104
Secondary outcomes:
measure: Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52
timeFrame: week 52
measure: Serum HBV DNA reduction from baseline at week 104
timeFrame: week 104
measure: Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline
timeFrame: week 104
measure: Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline
timeFrame: week 104
measure: Serum HBV DNA reduction from baseline at week 52
timeFrame: week 52
Other outcomes:
Locations:
city: BeiJing
country: China
facility: 302 Military Hospital of China
state: Beijing
city: Beijing
country: China
facility: Beijing Ditan Hospita
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Attached to the Capital Medical University
state: Beijing
city: BeiJing
country: China
facility: BeiJing YouAn Hospital ,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Department of infectious disease, First Hospital of Peking University
state: Beijing
city: Beijing
country: China
facility: People'S Hospital Under Beijnig University
state: Beijing
city: ChongQing
country: China
facility: The Second Affiliated of ChongQing University of Medical Science
state: Chongqing
city: Guangzhou
country: China
facility: Department of infectious disease, Nanfang Hospital
state: Guangdong
city: GuangZhou
country: China
facility: No. 8 People's Hospital In GuangZhou
state: Guangdong
city: GuangZhou
country: China
facility: The Third Hospital of Sun Yat-Sen University
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: ChangSha
country: China
facility: Xiangya Hospital Central-South Univrsity
state: Hunan
city: NanJing
country: China
facility: No.81 Hospital of PLA
state: Jiangsu
city: ChangChun
country: China
facility: First Hospital .Jilin Unniversity
state: Jilin
city: ShenYang
country: China
facility: ShengJing Hospital of China Medical University
state: Liaoning
city: JINan
country: China
facility: JiNan Infectious Diseases Hospital
state: Shandong
city: ShangHai
country: China
facility: Changhai Hospital affiliated to Second Military Medical University
state: Shanghai
city: ShangHai
country: China
facility: Huashan Hospital，Fudan University
state: Shanghai
city: ShangHai
country: China
facility: No.85 Hospital of PLA
state: Shanghai
city: ShangHai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
city: XiAn
country: China
facility: Tangdu Hospital
state: Shanxi
city: ChengDu
country: China
facility: West China Hospital.SiChuan University
state: Sichuan
city: HangZhou
country: China
facility: The First Affiliated Hospital of College of Medicine ，Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The Sixth People's Hospital of Hangzhou
state: Zhejiang
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jinlin Hou, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.