EFFicacy Optimization Research of Telbivudine Therapy
- Registration Number
- NCT00962533
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 606
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ROADMAP Group (Group I) telbivudine 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. SOC (Standard of Care) Group (Group II) telbivudine 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.
- Primary Outcome Measures
Name Time Method To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II Week 104
- Secondary Outcome Measures
Name Time Method Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52 week 52 Serum HBV DNA reduction from baseline at week 104 week 104 Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline 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 week 104 Serum HBV DNA reduction from baseline at week 52 week 52
Trial Locations
- Locations (24)
West China Hospital.SiChuan University
🇨🇳ChengDu, Sichuan, China
Changhai Hospital affiliated to Second Military Medical University
🇨🇳ShangHai, Shanghai, 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
BeiJing YouAn Hospital ,Capital Medical University
🇨🇳BeiJing, Beijing, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, 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
Huashan Hospital，Fudan University
🇨🇳ShangHai, Shanghai, China
ShengJing Hospital of China Medical University
🇨🇳ShenYang, Liaoning, China
Xiangya Hospital Central-South Univrsity
🇨🇳ChangSha, Hunan, China
First Hospital .Jilin Unniversity
🇨🇳ChangChun, Jilin, China
Department of infectious disease, Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
No.81 Hospital of PLA
🇨🇳NanJing, Jiangsu, China
The Sixth People's Hospital of Hangzhou
🇨🇳Hangzhou, Zhejiang, China
Tangdu Hospital
🇨🇳XiAn, Shanxi, China
No. 8 People's Hospital In GuangZhou
🇨🇳GuangZhou, Guangdong, China
The Third Hospital of Sun Yat-Sen University
🇨🇳GuangZhou, Guangdong, China
JiNan Infectious Diseases Hospital
🇨🇳JINan, Shandong, China
The First Affiliated Hospital of College of Medicine ，Zhejiang University
🇨🇳HangZhou, Zhejiang, China
No.85 Hospital of PLA
🇨🇳ShangHai, Shanghai, China
Shanghai Ruijin Hospital
🇨🇳ShangHai, Shanghai, China