NCT00412529

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2006

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 18, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

August 12, 2011

Completed
Last Updated

March 13, 2015

Status Verified

February 1, 2015

Enrollment Period

1.2 years

First QC Date

December 15, 2006

Results QC Date

December 2, 2010

Last Update Submit

February 23, 2015

Conditions

Hepatitis BChronic Hepatitis B

Keywords

HBeAg-positive, chronic hepatitis Btelbivudineentecavirviral kinetics

Outcome Measures

Primary Outcomes (1)

  • Change in Mean Hepatitis B Virus (HBV) DNA Levels

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

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

Secondary Outcomes (7)

  • Change in Mean HBV DNA Level

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

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

    From Baseline to Week 12

  • Change in Alanine Aminotransferase (ALT) Levels

    From Baseline to Week 12

  • Characterization of Very Early Viral Kinetics: Estimation of Viral Clearance

    Baseline to 12 weeks

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

    Baseline to 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Telbivudine

EXPERIMENTAL
Drug: Telbivudine

Entecavir

ACTIVE COMPARATOR
Drug: Entecavir

Interventions

EntecavirDRUG

Entecavir 0.5 mg once daily for 12 weeks.

Entecavir
TelbivudineDRUG

Telbivudine 600 mg once daily for 12 weeks.

Telbivudine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Holy Family Hospital_Bucheon

Bucheon,Kyunggi, South Korea

Location

Inje University Busan Paik Hospital

Busan, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Gachon Univ. Gil Medical Center Hospital

Incheon, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Kangnam Sacred Heart Hospital

Seoul, South Korea

Location

Korea University Medical Center_Anam

Seoul, South Korea

Location

The Catholic University of Korea

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 20028815RESULT

Related Links

MeSH Terms

Conditions

Hepatitis BHepatitis B, Chronic

Interventions

entecavirTelbivudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2006

First Posted

December 18, 2006

Study Start

December 1, 2006

Primary Completion

February 1, 2008

Last Updated

March 13, 2015

Results First Posted

August 12, 2011

Record last verified: 2015-02

Locations

KR(8)