Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Telbivudine in Chronic Hepatitis B

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00970216
Recruitment Status : Completed
First Posted : September 2, 2009
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment
Chronic Hepatitis B Drug: Telbivudine

Detailed Description:

Primary objective: To evaluate the antiviral efficacy of telbivudine by maintained suppression of HBV DNA(<=300 copies/ml or 60 IU/ml,undetectable by current PCR-based assays) in HBeAg positive patients from Week 24 to Week 48.

Methodology: This will be an open-label, prospective, observational, single-center and single arm post marketing surveillance study.

Number of patients: It is estimated to enroll 240 intent-to-treat patients in Taiwan.

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 160 participants
Time Perspective: Prospective
Official Title: A Prospective, Observational, Single-center Post-marketing Surveillance Study of Telbivudine in Chronic Hepatitis B Adults With HBeAg Positive/Negative.
Study Start Date : February 2009
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Telbivudine

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Drug: Telbivudine
    Post-marketing observation for chronic hepatitis B patients receiving Telbivudine treatment
    Other Name: Sebivo

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. HBV-DNA < 300 Copies/mL in 48 Weeks [ Time Frame: 48 weeks ]

Biospecimen Retention:   Samples With DNA
Serum will be stored at screening/baseline and complete study after corresponding with inclusion/exclusion criteria.

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  1. Male or female, at least 18 years of age.

  2. 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.
  3. Willing and able to comply with the observational drug regimen and all other study requirements.
  4. Willing and able to provide written informed consent to participate in the study.

Exclusion Criteria:

  1. Females who are pregnant,intending to become pregnant or breast feeding.
  2. Patients with co-infection with hepatitis C virus, hepatitis D virus or human immunodeficiency virus.
  3. Patients with hypersensitivity to telbivudine or to any of the excipients.
  4. 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.
  5. Enrolled or planning to be enrolled in another clinical trial of an investigational agent while participating in this study.
  6. Unable to receive safety and tolerability assessments.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970216


Locations
Layout table for location information
Taiwan
Chang Gung Memorial Hospital
LinKou, Taoyuan County, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chau-ting Yeh, MD,PhD Chang Gung Memorial Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT00970216    
Other Study ID Numbers: PMST-Y-1
First Posted: September 2, 2009    Key Record Dates
Results First Posted: February 29, 2016
Last Update Posted: February 29, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Chang Gung Memorial Hospital:
HBV DNA non-detectability
Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections
Telbivudine
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action