Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01341743
First received: February 16, 2011
Last updated: October 28, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Hepatitis B
Drug: Entecavir
Drug: Entecavir, Adefovir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum HBV DNA reduction from baseline at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with ALT normalization at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with HBeAg loss and seroconversion at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
  • The proportion of subject with HBsAg loss and seroconversion at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
oral entecavir 1mg daily for 104 weeks
Drug: Entecavir
patients will receive oral entecavir 1mg, daily for 104 weeks.
Active Comparator: B
oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
Drug: Entecavir, Adefovir
patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
Active Comparator: C
oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
Drug: Entecavir, Adefovir
patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341743

Locations
China, Beijing
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
China, Fujian
The First Affiliated Hospital of Fujian Medical University
FuZhou, Fujian, China
China, Guangdong
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
China, Guangxi
First Affiliated Hospital of Guangxi Medical University
NanNing, Guangxi, China
China, Hubei
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
China, Hunan
Xiangya Hospital Central-South Univrsity
ChangSha, Hunan, China
China, Jilin
First Hospital .Jilin Unniversity
ChangChun, Jilin, China
China, Liaoning
ShengJing Hospital of China Medical University
ShenYang, Liaoning, China
China, Shanghai
Changhai Hospital affiliated to Second Military Medical University
ShangHai, Shanghai, China
Huashan Hospital,Fudan University
ShangHai, Shanghai, China
Shanghai Ruijin Hospital
ShangHai, Shanghai, China
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
Investigators
Principal Investigator: JinLin Hou, MD Nanfang Hospital of Southern Medical University
  More Information

No publications provided

Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01341743     History of Changes
Other Study ID Numbers: MOH-04
Study First Received: February 16, 2011
Last Updated: October 28, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Nanfang Hospital of Southern Medical University:
chronic hepatitis B
inadequate response
NUC therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Adefovir
Adefovir dipivoxil
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on August 01, 2014