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Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy (Dragon-Ex)

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ClinicalTrials.gov Identifier: NCT01829685
Recruitment Status : Unknown
Verified June 2014 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Active, not recruiting
First Posted : April 11, 2013
Last Update Posted : June 19, 2014
Sponsor:
Collaborator:
Major Science and Technology Special Project of China Eleventh Five-year
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Brief Summary:
The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Inadequate Response Nucleos(t)Ide Analogues Treatment Drug: Entecavir, Adefovir Phase 4

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 3-year, Open-lable, Multi-center Extension Trial of Entecavir Therapy for Patients Previously Treated in Dragon Study
Study Start Date : March 2013
Estimated Primary Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Group I
oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks
Drug: Entecavir, Adefovir
Active Comparator: Group II
oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
Drug: Entecavir, Adefovir



Primary Outcome Measures :
  1. Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group [ Time Frame: Week 144 ]

Secondary Outcome Measures :
  1. Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group. [ Time Frame: Week 48 & 96 ]
  2. The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144. [ Time Frame: Week 48 & 96 &144 ]
  3. Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144. [ Time Frame: Week 48 & 96 & 144 ]
  4. Percentage of patients with ALT normalization at week 48/96/144 [ Time Frame: Week 48 & 96 & 144 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects who completed the 104-week Dragon study.
  • Subjects who are willing to participate the extension study.

Exclusion Criteria:

  • Subjects who could not compliance with the protocol judged by investigators

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): NCT01829685


Locations
China, Beijing
Beijing Ditan Hospital
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
Shengyang, 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
Major Science and Technology Special Project of China Eleventh Five-year
Investigators
Principal Investigator: Jinlin Hou, MD Nanfang Hospital of Southern Medical University

Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01829685     History of Changes
Other Study ID Numbers: MOH-06
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: June 19, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
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