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Phase 3 N=44 Randomized Treatment

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

Hepatitis B · Chronic Hepatitis B

Bottom Line

View on ClinicalTrials.gov: NCT00412529 ↗
Enrolled (actual)
44
Serious AEs
2.3%
Results posted
Aug 2011
Primary outcome: Primary: Change in Mean Hepatitis B Virus (HBV) DNA Levels — 10.290; 9.721; 3.669; 3.194 log10 copies/mL

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Entecavir (Drug); Telbivudine (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Novartis Pharmaceuticals
Primary completion
Feb 2008

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Mean Hepatitis B Virus (HBV) DNA Levels		 10.290; 9.721; 3.669; 3.194; -6.621; -6.527 —
SECONDARY
Change in Mean HBV DNA Level		 -3.999; -3.974; -5.273; -4.875; -6.161; -5.976 —
SECONDARY
The Area Under the Curve (AUC) of HBV DNA Change.		 -453.5; -442.6 —
SECONDARY
Change in Alanine Aminotransferase (ALT) Levels		 163.1; 170.2; 55.1; 54.0; -108.0; -116.3 —
SECONDARY
Characterization of Very Early Viral Kinetics: Estimation of Viral Clearance		 0.809; 1.002 —
SECONDARY
Characterization of Very Early Viral Kinetics: Estimation of the Rate of Infected Cell Loss		 0.075; 0.071 —
SECONDARY
Characterization of Very Early Viral Kinetics: Estimation of the Efficiency Factor of Blocking Virus Production		 0.991; 0.992 —
SECONDARY
Number of Patients Who Are Polymerase Chain Reaction (PCR) Negative		 2; 6; 21; 15 —

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00412529). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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