NCT00781105

Brief Summary

The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the proportion of patients achieving undetectable HBV DNA at week 52.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2008

Typical duration for phase_4

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

August 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2010

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

2.1 years

First QC Date

October 27, 2008

Last Update Submit

February 20, 2017

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis BAdultHBV DNA suppressionTelbivudine

Outcome Measures

Primary Outcomes (1)

  • HBV DNA PCR negativity rate

    at 52 weeks

Secondary Outcomes (6)

  • HBV DNA PCR negativity rate

    at week 24

  • DNA reduction

    from baseline to Weeks 12, 24, 36, 52

  • HBeAg loss rate

    at week 52

  • HBeAg seroconversion rate

    at week 52

  • ALT normalization rate

    at weeks 24 and 52

  • +1 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL
Drug: Telbivudine

Interventions

TelbivudineDRUG

600 mg/day, oral tablets, once daily, 52 weeks

1

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female 16 to 65 year of age
  • Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
  • Willing and able to comply with the study drug regimen
  • Written informed consent before any assessment

You may not qualify if:

  • Patient has a history of/or clinical signs/symptoms of hepatic decompensation
  • Patient has a history of HCC or findings suggestive of possible HCC
  • Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
  • History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
  • Patient has received IFN or other immunomodulatory treatment with 12 months before screening
  • Previous treatment history with NRTIs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Beijing, China

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

  • Jia Jidong, Dr.

    Beijing Friendship Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2008

First Posted

October 28, 2008

Study Start

August 1, 2008

Primary Completion

September 16, 2010

Study Completion

September 16, 2010

Last Updated

February 23, 2017

Record last verified: 2017-02

Locations

CN(1)