NCT00275652

Brief Summary

This trial is being done to see if the investigational drug, LdT (Telbivudine), is safe and effective in the treatment of hepatitis B infection. In addition to this, we will be looking at the comparison of the effects (good and bad) of LdT and lamivudine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2004

Typical duration for phase_3

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

June 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

March 23, 2011

Status Verified

March 1, 2011

Enrollment Period

3.2 years

First QC Date

January 10, 2006

Last Update Submit

March 22, 2011

Conditions

Hepatitis BCirrhosis

Outcome Measures

Primary Outcomes (5)

  • A composite endpoint called "clinical response" which is defined as HBV DNA <10 4 copies/ml and normal ALT and improvement, or stabilization in CTP score.

  • Durability of clinical response

  • Proportion of patients achieving improvement, stabilization, and worsening in CTP score

  • Proportion of patients with normal ALT

  • Improvements in serum albumin levels, in patients with hypoalbuminemia pre-treatment

Secondary Outcomes (5)

  • Time to clinical response

  • Duration of clinical response

  • Proportion of patients achieving improvement, stabilization, and worsening in CTP score

  • Improvement, stabilization, and worsening in a modified CTP score.

  • ALT normalization.

Interventions

LdT (Telbivudine) and lamivudineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Patients with chronic hepatitis b with evidence of cirrhosis, who are at least 18 to 70 years old, may be eligible to participate in this study.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hepatitis BFibrosis

Interventions

TelbivudineLamivudine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • W. Ray Kim, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 12, 2006

Study Start

June 1, 2004

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

March 23, 2011

Record last verified: 2011-03

Locations

US(1)