NCT00640588

Brief Summary

This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

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

March 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 21, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

March 17, 2008

Last Update Submit

March 24, 2017

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis B, chronicViral kineticsTelbivudineAdefovirCompliance

Outcome Measures

Primary Outcomes (1)

  • HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks

    at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks

Secondary Outcomes (1)

  • Liver function assessed at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks HBV genotype measured at baseline

    at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks

Study Arms (2)

1

EXPERIMENTAL

Telbivudine

Drug: Telbivudine

2

ACTIVE COMPARATOR

Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks

Drug: oral adefovir

Interventions

TelbivudineDRUG

Arm 1: 600 mg/day, oral telbivudina for 24 weeks

Also known as: Sebivo, Tyzeka, Hepsera
1
oral adefovirDRUG

Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks

Also known as: adefovir
2

Eligibility Criteria

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

You may qualify if:

  • Male or female, at least 18 years of age.
  • Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria.

You may not qualify if:

  • Co-infection with HCV, HDV, or HIV.
  • Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir.
  • History of hepatic decompensation
  • History of malignancy
  • Patient has one or more additional known primary or secondary causes of liver disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Barcelona, Spain

Location

MeSH Terms

Conditions

Hepatitis B, ChronicPatient Compliance

Interventions

Telbivudineadefovir dipivoxiladefovir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 21, 2008

Study Start

March 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

ES(1)