NCT01380951

Brief Summary

Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2011

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

1.6 years

First QC Date

June 23, 2011

Last Update Submit

June 23, 2011

Conditions

Liver CirrhosisChronic Hepatitis B

Keywords

liver cirrhosischronic hepatitis Bantiviral therapytelbivudine

Outcome Measures

Primary Outcomes (1)

  • Serum HBV DNA

    serum HBV DNA negativity and decline from baseline at week 48

    48 weeks

Secondary Outcomes (2)

  • Serum HBeAg

    48 weeks

  • Child-pugh score

    48 weeks

Study Arms (1)

telbivudine

EXPERIMENTAL
Drug: telbivudine

Interventions

telbivudineDRUG

telbivudine 600mg/d 96 weeks

Also known as: Sebivo
telbivudine

Eligibility Criteria

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

You may qualify if:

  • liver cirrhosis with CHB
  • without history of antiviral therapy or discontinued antiviral therapy for more than 6 months
  • for patients with compensated liver cirrhosis: HBV DNA≥4log copies/ml if HBeAg positive,HBV DNA≥3log copies/ml if HBeAg negative
  • for patients with uncompensated liver cirrhosis:HBV DNA positive

You may not qualify if:

  • coinfection with HCV,HDV and HIV
  • AFP≥100mg/L or HCC diagnosed by iconography
  • with severe cardiovascular, respiratory and endocrinology diseases or autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Fifth People's Hospital of Suzhou

Suzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisHepatitis B, Chronic

Interventions

Telbivudine

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisChronic DiseaseDisease Attributes

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Chuanwu Zhu, Doctor

    The Fifth People's Hospital of Suzhou

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 23, 2011

First Posted

June 27, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2013

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

CN(1)