Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC 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
Intervention: Entecavir (Drug); Entecavir, Adefovir (Drug); Entecavir, Adefovir (Drug)
Phase: Phase 4
Status: Active, not recruiting
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 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
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104
Secondary outcome: serum HBV DNA reduction from baseline at week 104The proportion of subjects with ALT normalization at week 104 The proportion of subjects with HBeAg loss and seroconversion at week 104 The proportion of subject with HBsAg loss and seroconversion at week 104 The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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;
- Other protocol defined exclusion criteria.
Locations and Contacts
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
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, China
Huashan Hospital,Fudan University, ShangHai, Shanghai, China
Shanghai Ruijin Hospital, ShangHai, Shanghai, China
Additional Information
Starting date: December 2010
Last updated: October 28, 2013
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