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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Major Science and Technology Special Project of China Eleventh Five-year
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01829685
First received: April 9, 2013
Last updated: June 17, 2014
Last verified: June 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group [ Time Frame: Week 144 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group. [ Time Frame: Week 48 & 96 ] [ Designated as safety issue: No ]
  • The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144. [ Time Frame: Week 48 & 96 &144 ] [ Designated as safety issue: No ]
  • Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144. [ Time Frame: Week 48 & 96 & 144 ] [ Designated as safety issue: No ]
  • Percentage of patients with ALT normalization at week 48/96/144 [ Time Frame: Week 48 & 96 & 144 ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: March 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  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: NCT01829685

Locations
China, Beijing
Beijing Ditan Hospital
Beijing, Beijing, China
Beijing Friendship Hospital Attached To The Capital Medical University
Beijing, Beijing, China
People's Hospital Under Beijnig University
Beijing, Beijing, China
Department of infectious disease, First Hospital of Peking 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
GuangDong Provincial People's hospital
GuangZhou, Guangdong, China
Department of Infectious Disease, Nanfang 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
Shanghai Ruijin Hospital
Shanghai, Shanghai, China
Changhai Hospital affiliated to Second Military Medical University
Shanghai, Shanghai, China
Huashan Hospital,Fudan University
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
  More Information

No publications provided

Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01829685     History of Changes
Other Study ID Numbers: MOH-06
Study First Received: April 9, 2013
Last Updated: June 17, 2014
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014