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Hepatitis BPhase 3NCT00412529

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

A Phase 3 study testing Entecavir and Telbivudine in people with Hepatitis B and Chronic Hepatitis B, run by Novartis Pharmaceuticals at 8 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis B, Chronic Hepatitis B
What is being tested?
Entecavir and Telbivudine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
8 sitesSouth Korea
Study dates
Dec 2006to Feb 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

South Korea8 sites

  • Holy Family Hospital_Bucheon

    Bucheon,Kyunggi

  • Inje University Busan Paik Hospital

    Busan

  • Yeungnam University Medical Center

    Daegu

  • Gachon Univ. Gil Medical Center Hospital

    Incheon

  • Asan Medical Center

    Seoul

  • Kangnam Sacred Heart Hospital

    Seoul

  • Korea University Medical Center_Anam

    Seoul

  • The Catholic University of Korea

    Seoul

Other trials in South Korea

About this study

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)

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.

Being tested
Entecavir, Telbivudine
Keywords
HBeAg-positive, chronic hepatitis B, telbivudine, entecavir, viral kinetics
Medical subject headings
Hepatitis B, Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EntecavirDrug

    Entecavir 0.5 mg once daily for 12 weeks.

  • TelbivudineDrug

    Telbivudine 600 mg once daily for 12 weeks.

Study groups in NCT00412529
Study groupRoleWhat they receive
TelbivudineExperimentalNot described
Receives: Drug: Telbivudine
EntecavirActive comparatorNot described
Receives: Drug: Entecavir

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Baseline (day 1) to Week 12 (day 85)

Secondary outcomes (7)

  1. Change in Mean HBV DNA Level

    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.

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

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

    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.

    Measured: From Baseline to Week 12

  3. Change in Alanine Aminotransferase (ALT) Levels

    Measured: From Baseline to Week 12

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

    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.

    Measured: Baseline to 12 weeks

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

    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.

    Measured: Baseline to 12 weeks

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

    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.

    Measured: Baseline to 12 weeks

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

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

    Measured: At Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2006 (estimated)
  2. Study startDec 2006
  3. Primary completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00412529
Sponsor's protocol ID
CLDT600A2407
Status last verified
Feb 2015
First submitted
15 Dec 2006
Last updated
13 Mar 2015

Publications

  • 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.

    PubMed 20028815

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Entecavir and Telbivudine in people with Hepatitis B and Chronic Hepatitis B, run by Novartis Pharmaceuticals at 8 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mean Hepatitis B Virus (HBV) DNA Levels (time frame: Baseline (day 1) to Week 12 (day 85)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00412529, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2015.

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