Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
A Multi-center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Generic Entecavir Monotherapy or in Combination With Adefovir for Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
1 other identifier
interventional
360
1 country
16
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2010
Longer than P75 for phase_4
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 16, 2011
CompletedFirst Posted
Study publicly available on registry
April 26, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedOctober 30, 2013
September 1, 2013
3.5 years
February 16, 2011
October 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104
week 104
Secondary Outcomes (5)
serum HBV DNA reduction from baseline at week 104
week 104
The proportion of subjects with ALT normalization at week 104
week104
The proportion of subjects with HBeAg loss and seroconversion at week 104
week104
The proportion of subject with HBsAg loss and seroconversion at week 104
week104
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104
week104
Study Arms (3)
A
ACTIVE COMPARATORoral entecavir 1mg daily for 104 weeks
B
ACTIVE COMPARATORoral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
C
ACTIVE COMPARATORoral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
Interventions
patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
Eligibility Criteria
You may qualify if:
- Male or female aged 18-65 years;
- Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
- Serum HBsAg positive and ALT\<10ULN at study screening;
- Patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;
You may not qualify if:
- History of viral breakthrough or genotypic resistance on previous therapy;
- History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
- Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of possible HCC;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Beijing Ditan Hospita
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Attached to the Capital Medical University
Beijing, Beijing Municipality, China
Department of infectious disease, First Hospital of Peking University
Beijing, Beijing Municipality, China
People'S Hospital Under Beijnig University
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Department of infectious disease, Nanfang Hospital
Guangzhou, Guangdong, China
GuangDong Provincial People's hospital
Guangzhou, Guangdong, China
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 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
First Hospital .Jilin Unniversity
Changchun, Jilin, China
ShengJing Hospital of China Medical University
Shenyang, Liaoning, China
Changhai Hospital affiliated to Second Military Medical University
Shanghai, Shanghai Municipality, China
Huashan Hospital，Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
JinLin Hou, MD
Nanfang Hospital, Southern Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2011
First Posted
April 26, 2011
Study Start
December 1, 2010
Primary Completion
June 1, 2014
Study Completion
December 1, 2014
Last Updated
October 30, 2013
Record last verified: 2013-09