NCT00467545

Brief Summary

This study is to evaluate the safety of telbivudine for up to 21 months of open-label treatment in patients with chronic hepatitis B who have completed the CLDT600A2407 trial. Patients treated with telbivudine during core phase will continue telbivudine and patients treated with entecavir during core phase will be switched to telbivudine if the patient is willing to enroll this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2007

Typical duration for phase_4

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 30, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

June 23, 2017

Status Verified

May 1, 2012

Enrollment Period

2.4 years

First QC Date

April 27, 2007

Last Update Submit

June 21, 2017

Conditions

Chronic Hepatitis B

Keywords

HBeAg-positivechronic hepatitis Btelbivudine

Outcome Measures

Primary Outcomes (1)

  • Safety of telbivudine (LDT600) up to 21 additional months of open-label treatment in patients with chronic hepatitis B who have completed study CLDT600A2407 assessed by Adverse Events, data of vital signs and other tests

Secondary Outcomes (1)

  • Safety of patients switched from entecavir to telbivudine compared with patients continuing telbivudine assessed by Adverse Events, data of vital signs and other tests

Interventions

telbivudineDRUG

Eligibility Criteria

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

You may qualify if:

  • The patient has completed the previous CLDT600A2407 study and is able to immediately enter this extension study with no study drug discontinuation
  • Patient is willing and able to comply with the study drug regimen and all other study requirements
  • The patient is willing and able to provide written informed consent to participate in the extension study.

You may not qualify if:

  • Patient is pregnant or breastfeeding.
  • Patient is co-infected with HCV, HDV, or HIV.
  • History of malignancy of any organ system, treated or untreated, within the past 5 years with the exception of localized basal cell carcinoma of the skin.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Novartis Investigative Site (705-035)

Daegu, South Korea

Location

Novartis Investigative Site , (420-717)

Gyeonggi-do, South Korea

Location

Novartis Investigative Site , (405-760)

Incheon, South Korea

Location

Novartis Investigative Site , (136-705)

Seoul, South Korea

Location

Novartis Investigative Site , (150-590)

Seoul, South Korea

Location

Novartis Investigative Site

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Telbivudine

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2007

First Posted

April 30, 2007

Study Start

April 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

June 23, 2017

Record last verified: 2012-05

Locations

KR(6)