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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 104

The 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

Page last updated: August 23, 2015

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