Clinical trial NCT00412529: Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
Official 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Chronic Hepatitis B
Keywords: HBeAg-positive, chronic hepatitis B
telbivudine
entecavir
viral kinetics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Change in Mean Hepatitis B Virus (HBV) DNA Levels
timeFrame: Baseline (day 1) to Week 12 (day 85)
Secondary outcomes:
measure: Change in Mean HBV DNA Level
timeFrame: Baseline (day 1) to Weeks 2, 4, 8
measure: The Area Under the Curve (AUC) of HBV DNA Change.
timeFrame: From Baseline to Week 12
measure: Change in Alanine Aminotransferase (ALT) Levels
timeFrame: From Baseline to Week 12
measure: Characterization of Very Early Viral Kinetics: Estimation of Viral Clearance
timeFrame: Baseline to 12 weeks
measure: Characterization of Very Early Viral Kinetics: Estimation of the Rate of Infected Cell Loss
timeFrame: Baseline to 12 weeks
measure: Characterization of Very Early Viral Kinetics: Estimation of the Efficiency Factor of Blocking Virus Production
timeFrame: Baseline to 12 weeks
measure: Number of Patients Who Are Polymerase Chain Reaction (PCR) Negative
timeFrame: At Week 12
Other outcomes:
Locations:
city: Bucheon,Kyunggi
country: Korea, Republic of
facility: Holy Family Hospital_Bucheon
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Incheon
country: Korea, Republic of
facility: Gachon Univ. Gil Medical Center Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center_Anam
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Suh DJ, Um SH, Herrmann E, Kim JH, Lee YS, Lee HJ, Lee MS, Lee YJ, Bao W, Lopez P, Lee HC, Avila C, Zeuzem S. Early viral kinetics of telbivudine and entecavir: results of a 12-week randomized exploratory study with patients with HBeAg-positive chronic hepatitis B. Antimicrob Agents Chemother. 2010 Mar;54(3):1242-7. doi: 10.1128/AAC.01163-09. Epub 2009 Dec 22.