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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01341743
Recruitment Status : Unknown
Verified September 2013 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Active, not recruiting
First Posted : April 26, 2011
Last Update Posted : October 30, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: Entecavir Drug: Entecavir, Adefovir Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2010
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104 [ Time Frame: week 104 ]

Secondary Outcome Measures :
  1. serum HBV DNA reduction from baseline at week 104 [ Time Frame: week 104 ]
  2. The proportion of subjects with ALT normalization at week 104 [ Time Frame: week104 ]
  3. The proportion of subjects with HBeAg loss and seroconversion at week 104 [ Time Frame: week104 ]
  4. The proportion of subject with HBsAg loss and seroconversion at week 104 [ Time Frame: week104 ]
  5. The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104 [ Time Frame: week104 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01341743     History of Changes
Other Study ID Numbers: MOH-04
First Posted: April 26, 2011    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: September 2013

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
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
Entecavir
Adefovir
Adefovir dipivoxil
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents