3E Extension Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Major Science and Technology Special Project of China 12th Five-year
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01834508
First received: April 14, 2013
Last updated: June 17, 2014
Last verified: June 2014

April 14, 2013
June 17, 2014
March 2013
June 2016   (final data collection date for primary outcome measure)
Percentages of patients achieving HBV DNA< 300copies/mL at week 144 [ Time Frame: Week 144 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01834508 on ClinicalTrials.gov Archive Site
  • Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 [ 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
 
3E Extension Study
A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Plus Adefovir Combination Treatment for Patients Previously Treated in EXPLORE, EXCEL and EFFORT Ex Study

The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
Treatment group
Intervention: Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
600
December 2016
June 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT 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 information is only displayed when the study is recruiting subjects
China
 
NCT01834508
MOH-07
Yes
Nanfang Hospital of Southern Medical University
Nanfang Hospital of Southern Medical University
Major Science and Technology Special Project of China 12th Five-year
Not Provided
Nanfang Hospital of Southern Medical University
June 2014

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