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Completed

NCT Number: NCT00625560

Continuing Lamivudine vs Switching to Entecavir in Patients With Detectable HBV DNA

This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 1 mg QD from lamivudine versus maintaining lamivudine 100 mg QD treatment in HBV-infected subjects currently receiving lamivudine monotherapy.

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Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pusan National University School of Medicine, Busan, South Korea

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About this study

Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than Lamivudine in nucleoside-naïve CHB patients. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to full viral suppression to undetectable level by PCR method. The prompt switch from Lamivudine to Entecavir in patients who have insufficient hepatitis B virus suppression (HBV DNA ≥ 60 IU/mL) may preclude development of drug resistance. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with ≥ HBV DNA 60 IU/mL level and HBeAg positive at baseline.

Exclusion criteria

  • All subjects will be tested for presence of M204V/I mutations in the YMDD motif at baseline. Subjects with M204V/I mutations in the YMDD motif at baseline are not eligible for the study.
  • Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.
  • Subjects should have ALT < 10 x ULN, and no evidence of hepatocellular carcinoma.
  • Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
  • Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.

Treatment and study plan

Entecavir

Drug

entecavir 1.0 mg QD

Other names: Baraclude 1.0mg

Lamivudine

Drug

lamivudine 100 mg QD

Other names: Zeffix 100mg

Primary outcomes

  1. Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy

    Time frame: at Week 96

Secondary outcomes

  1. Percentage number of patients with HBV DNA < 60 IU/mL while on randomized therapy

    Time frame: at Week 48

  2. Percentage number of patients who developed drug resistant mutations while on randomized therapy

    Time frame: at Week 48 and Week 96

  3. Change from baseline in mean HBV DNA

    Time frame: at Week 48 and 96

  4. Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion

    Time frame: at Week 48 and 96

  5. Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough Safety assessment

    Time frame: Follow up period

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Collaborators

  • Pusan National University Hospital

Registry information

Official study title

Randomized, Open-Labelled Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Continuing Lamivudine Therapy or Switching to Entecavir in Subjects With Chronic Hepatitis B With Detectable HBV DNA

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Feb 28, 2008
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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