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3E Extension Study (3E Ex)

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: NCT01834508
Recruitment Status : Unknown
Verified June 2014 by Nanfang Hospital of Southern Medical University.
Recruitment status was:  Active, not recruiting
First Posted : April 18, 2013
Last Update Posted : June 19, 2014
Sponsor:
Collaborator:
Major Science and Technology Special Project of China 12th Five-year
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2013
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

Arms and Interventions
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Arm Intervention/treatment
Treatment group Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks


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

Secondary Outcome Measures :
  1. Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 [ 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 ]

Eligibility Criteria
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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 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
Contacts and Locations
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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): NCT01834508


Locations
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Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Major Science and Technology Special Project of China 12th Five-year
More Information
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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01834508    
Other Study ID Numbers: MOH-07
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: June 19, 2014
Last Verified: June 2014
Keywords provided by Nanfang Hospital of Southern Medical University:
Experienced Treatment
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis B, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Blood-Borne Infections
Communicable Diseases
Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
 Hepatitis, Viral, Human
Hepatitis, Chronic
Entecavir
Adefovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action