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

This study is currently recruiting participants.
Verified April 2013 by Nanfang Hospital of Southern Medical University
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: NA
Last verified: April 2013
History: No changes posted

April 9, 2013
April 9, 2013
March 2013
June 2016   (final data collection date for primary outcome measure)
Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Therapy for Patients Previously Treated in Dragon Study

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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Hepatitis B
  • Inadequate Response
  • Nucleos(t)Ide Analogues Treatment
Drug: Entecavir, Adefovir
  • Active Comparator: Group I
    oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks
    Intervention: Drug: Entecavir, Adefovir
  • Active Comparator: Group II
    oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
    Intervention: Drug: Entecavir, Adefovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
360
Not Provided
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Jinlin Hou, MD 86-20-61641941 jlhousmu@yahoo.com.cn
Contact: Jian Sun 86-20-62787432 sunjian@fimmu.com
China
 
NCT01829685
MOH-06
Yes
Nanfang Hospital of Southern Medical University
Nanfang Hospital of Southern Medical University
Major Science and Technology Special Project of China Eleventh Five-year
Principal Investigator: Jinlin Hou, MD Nanfang Hospital of Southern Medical University
Nanfang Hospital of Southern Medical University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP