NCT00128544

Brief Summary

This study is being conducted to compare the effectiveness of the combination of valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2005

Geographic Reach
3 countries

3 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

May 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 10, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

June 16, 2017

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

August 8, 2005

Last Update Submit

June 15, 2017

Conditions

Hepatitis B

Interventions

telbivudineDRUG
valtorcitabineDRUG

Eligibility Criteria

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

You may qualify if:

  • Clinical history compatible with compensated chronic hepatitis B

You may not qualify if:

  • Patient is pregnant or breastfeeding
  • Patient is co-infected with hepatitis C virus, hepatitis D virus or HIV
  • Patient has previously received lamivudine, adefovir dipivoxil or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide at anytime.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Pokfulam, Hong Kong

Location

Unknown Facility

Auckland, New Zealand

Location

Unknown Facility

Singapore, Singapore

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Telbivudine

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 10, 2005

Study Start

May 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

June 16, 2017

Record last verified: 2017-06

Locations

NZ(1)SG(1)HK(1)