EFFicacy Optimization Research of Telbivudine Therapy
Information source: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B, Chronic
Intervention: telbivudine (Drug); telbivudine (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Nanfang Hospital of Southern Medical University Official(s) and/or principal investigator(s): Jinlin Hou, MD, Principal Investigator, Affiliation: Nanfang Hospital of Southern Medical University
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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: Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52Serum 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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
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
BeiJing YouAn Hospital ,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
The Second Affiliated of ChongQing University of Medical Science, ChongQing, Chongqing, China
Department of infectious disease, Nanfang Hospital, Guangzhou, Guangdong, China
No. 8 People's Hospital In GuangZhou, GuangZhou, Guangdong, China
The Third Hospital of Sun Yat-Sen University, GuangZhou, Guangdong, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China
Xiangya Hospital Central-South Univrsity, ChangSha, Hunan, China
No.81 Hospital of PLA, NanJing, Jiangsu, China
First Hospital .Jilin Unniversity, ChangChun, Jilin, China
ShengJing Hospital of China Medical University, ShenYang, Liaoning, China
JiNan Infectious Diseases Hospital, JINan, Shandong, 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, ShangHai, Shanghai, China
Tangdu Hospital, XiAn, Shanxi, China
West China Hospital.SiChuan University, ChengDu, Sichuan, China
The First Affiliated Hospital of College of Medicine ,Zhejiang University, HangZhou, Zhejiang, China
The Sixth People's Hospital of Hangzhou, Hangzhou, Zhejiang, China
Additional Information
Related publications: 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. Epub 2007 Jul 13. Review.
Starting date: August 2009
Last updated: January 29, 2013
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