NCT00970216

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and antiviral efficacy of telbivudine by maintained suppression of hepatitis B virus (HBV) DNA (\<=300 copies/ml or 60IU/ml, undetectable by current polymerase chain reaction (PCR) - based assays) in HBeAg positive/negative patients at physician's general practice.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2009

Longer than P75 for all trials

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

February 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2009

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2 months until next milestone

Results Posted

Study results publicly available

February 29, 2016

Completed
Last Updated

February 29, 2016

Status Verified

January 1, 2016

Enrollment Period

6.9 years

First QC Date

September 1, 2009

Results QC Date

January 31, 2016

Last Update Submit

January 31, 2016

Conditions

Chronic Hepatitis B

Keywords

HBV DNA non-detectability

Outcome Measures

Primary Outcomes (1)

  • HBV-DNA < 300 Copies/mL in 48 Weeks

    48 weeks

Interventions

TelbivudineDRUG

Post-marketing observation for chronic hepatitis B patients receiving Telbivudine treatment

Also known as: Sebivo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male or female patients, at least 18 years of age diagnosed with chronic hepatitis B with liver disease and telbivudine is prescribed by physicians based on clinical justification. And patients are able to communicate well, provide written informed consent, and willing to participate in the entire study.

You may qualify if:

  • Male or female, at least 18 years of age.
  • Documented chronic hepatitis B defined by all of the following:
  • Clinical history compatible with chronic hepatitis B.
  • Detectable serum hepatitis B surface antigen \>= 6 months at screening visit, with either HBeAg positive or negative.
  • Willing and able to comply with the observational drug regimen and all other study requirements.
  • Willing and able to provide written informed consent to participate in the study.

You may not qualify if:

  • Females who are pregnant,intending to become pregnant or breast feeding.
  • Patients with co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus.
  • Patients with hypersensitivity to telbivudine or to any of the excipients.
  • One or more known primary or secondary causes of liver disease other than hepatitis B (e.g., alcoholism, steatohepatitis, autoimmune hepatitis, hemochromatosis, alpha-1 anti-trypsin deficiency, Wilson's disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease). Gilbert's syndrome and Dubin-Johnson syndrome will not exclude patients from participation in this trial.
  • Enrolled or planning to be enrolled in another clinical trial of an investigational agent while participating in this study.
  • Unable to receive safety and tolerability assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

LinKou, Taoyuan County, Taiwan

Location

Related Publications (1)

  • Lin CL, Chien RN, Yeh C, Hsu CW, Chang ML, Chen YC, Yeh CT. Significant renoprotective effect of telbivudine during preemptive antiviral therapy in advanced liver cancer patients receiving cisplatin-based chemotherapy: a case-control study. Scand J Gastroenterol. 2014 Dec;49(12):1456-64. doi: 10.3109/00365521.2014.962604. Epub 2014 Oct 6.

    PMID: 25283499DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum will be stored at screening/baseline and complete study after corresponding with inclusion/exclusion criteria.

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

Results Point of Contact

Title
Chau-Ting Yeh
Organization
Chang Gung Memorial Hospital
chautingy@gmail.com
88633281200

Study Officials

  • Chau-ting Yeh, MD,PhD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2009

First Posted

September 2, 2009

Study Start

February 1, 2009

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 29, 2016

Results First Posted

February 29, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)