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Efficacy Optimizing Research of Lamivudine Therapy (EXPLORE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Major Science and Technology Special Project of China Eleventh Five-year
GlaxoSmithKline
Information provided by:
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01088009
First received: March 15, 2010
Last updated: March 2, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.


Condition Intervention Phase
Compensated Chronic Hepatitis B
 Drug: lamivudine
Drug: lamivudine, adefovir
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Open-label, Multi-centre Study to Compare Three Chronic Hepatitis B (CHB) Treatment Strategies Over a 2year Period in Chinese HBeAg Positive CHB Patients

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • the proportion of virological breakthrough with confirmed Lamivudine resistant mutants [ Time Frame: during 104 weeks study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104 [ Time Frame: baseline, week 104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with ALT normalization at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with HBeAg loss and seroconversion at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with HBsAg loss and seroconversion rates at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]

Estimated Enrollment: 360
Study Start Date: March 2010
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: early add-on Drug: lamivudine
patients in this arm will receive oral lamivudine 100mg,daily for 24 weeks; if patients with HBV DNA higher than 1000 copies/ml at week 24, add on adefovir to week 104; otherwise, keep lamivudine monotherapy to week 104
Active Comparator: SOC
Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
 Drug: lamivudine
Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
De-novo combination
patients in this arm will receive oral lamivudine 100mg and adefovir 10mg for 104 weeks
 Drug: lamivudine, adefovir
patients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg for 104 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female aged 18-65 years;
  • Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
  • Serum HBsAg and HBeAg positive at study screening; Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months;

Exclusion Criteria:

  • History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
  • other protocol defined inclusion/exclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088009

  Show 24 Study Locations
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Major Science and Technology Special Project of China Eleventh Five-year
GlaxoSmithKline
Investigators
Principal Investigator: JinLin Hou, MD Nanfang Hospital,Southern Medical University
  More Information

No publications provided

Responsible Party: Jinlin Hou, Nanfang hospital
ClinicalTrials.gov Identifier: NCT01088009     History of Changes
Other Study ID Numbers: MOH-02
Study First Received: March 15, 2010
Last Updated: March 2, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Nanfang Hospital of Southern Medical University:
chronic hepatitis B

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

ClinicalTrials.gov processed this record on May 16, 2013