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Completed

NCT Number: NCT00412529

Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B

This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple time points over 12 weeks.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Chronic Disease Chronic Hepatitis B Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B, Chronic 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 3

Primary location

Holy Family Hospital_Bucheon, Bucheon,Kyunggi, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female, 18-70 years of age with documented compensated hepatitis B "e" antigen (HBeAg)-positive chronic hepatitis B
  • Able to comply with study regimen and provide written informed consent

Exclusion criteria

  • Pregnant or breastfeeding
  • Unwilling to use double barrier method of contraception
  • Co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
  • Received Hepatitis B therapy in the past
  • Use of immunomodulatory therapy in past 12 months
  • History of or symptoms of hepatic decompensation or pancreatitis
  • Frequent or prolonged use of potentially hepatotoxic or nephrotoxic drugs
  • Concurrent medication likely to preclude compliance with schedule of evaluations
  • Use of other investigational drugs within 30 days of enrollment
  • Abnormal laboratory values during screening

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Entecavir

Drug

Entecavir 0.5 mg once daily for 12 weeks.

telbivudine

Drug

Telbivudine 600 mg once daily for 12 weeks.

Primary outcomes

  1. Change in Mean Hepatitis B Virus (HBV) DNA Levels

    Time frame: Baseline (day 1) to Week 12 (day 85)

    Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.

Secondary outcomes

  1. Change in Mean HBV DNA Level

    Time frame: Baseline (day 1) to Weeks 2, 4, 8

    Baseline HBV DNA is defined as the last pre-dose assessment of HBV DNA.HBV DNA reductions, considered as the repeated measures, from baseline to Weeks 2, 4, 8.

  2. The Area Under the Curve (AUC) of HBV DNA Change.

    Time frame: From Baseline to Week 12

    In AUC efficacy analyses, all the visits from baseline to Week 12 visit (including the planned and the repeated) with a non-missing HBV DNA level were included.

  3. Change in Alanine Aminotransferase (ALT) Levels

    Time frame: From Baseline to Week 12

  4. Characterization of Very Early Viral Kinetics: Estimation of Viral Clearance

    Time frame: Baseline to 12 weeks

    Viral kinetic parameters were estimated with a bi-phasic mathematical model:

    V(t) = (1-ε)pI(t) - cV(t)

    I(t) = (1- η)TV(t) - δI(t)

    V serum viral load, I productively infected cells, ε efficiency factor of blocking virus production, p viral production rate, c viral clearance rate, η efficiency factor of blocking de novo infection, β de novo infection rate, T uninfected target cells, δ rate of infected cell loss. Maximum-likelihood estimation for the viral kinetic parameters entailed fitting a nonlinear differential equation system via the least-squares approach from serum HBV DNA data.

  5. Characterization of Very Early Viral Kinetics: Estimation of the Rate of Infected Cell Loss

    Time frame: Baseline to 12 weeks

    Viral kinetic parameters were estimated with a bi-phasic mathematical model:

    V(t) = (1-ε)pI(t) - cV(t)

    I(t) = (1- η)TV(t) - δI(t)

    V serum viral load, I productively infected cells, ε efficiency factor of blocking virus production, p viral production rate, c viral clearance rate, η efficiency factor of blocking de novo infection, β de novo infection rate, T uninfected target cells, δ rate of infected cell loss. Maximum-likelihood estimation for the viral kinetic parameters entailed fitting a nonlinear differential equation system via the least-squares approach from serum HBV DNA data.

  6. Characterization of Very Early Viral Kinetics: Estimation of the Efficiency Factor of Blocking Virus Production

    Time frame: Baseline to 12 weeks

    Viral kinetic parameters were estimated with a bi-phasic mathematical model of HBV DNA by using compartments of free virus, infected cells, and uninfected target cells. The model parameter of interest was the effectiveness of the drug in blocking virus production from infected cells (efficacy, ε). Blocking efficiency was within the range between 0 and 1.

  7. Number of Patients Who Are Polymerase Chain Reaction (PCR) Negative

    Time frame: At Week 12

    PCR negative was considered <300 copies/mL. PCR positive was considered =>300 copies/mL.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Open-label, Controlled, Multicenter, Exploratory Trial to Characterize the Results of Daily Oral Administration of Telbivudine (LDT600) 600 mg or Entecavir (ETV) 0.5 mg Given Over 12 Weeks on the Kinetics of Hepatitis B Virus (HBV) DNA in Adults With HBeAg-positive, Compensated Chronic Hepatitis B (CHB)

Important dates

Study start
2006
Primary completion
2008
First posted
Dec 18, 2006
Registry last updated
Mar 13, 2015

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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