Prospective Exploratory Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B

June 21, 2017 updated by: Novartis

A Single Arm, Multicenter, Open-label, 52-week, the Omnibus Extension Study to Evaluate the Safety and Efficacy of Telbivudine in the Fifth Year of Treatment in Chinese Patients With Compensated Chronic Hepatitis B and Are HBV DNA PCR Negative at the End of Year 4 Treatment

This study will explore efficacy and safety of Telbivudine in the fifth year of treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  • Patient completed Omnibus study and will be available to immediately rollover into this study without discontinuation of study drug.
  • Patient was not discontinued from the previous Omnibus study.
  • Male or female, adult patients with CHB (HBeAg positive or HBeAg negative).
  • Patient is willing and able to provide written informed consent to participate in the study.
  • HBV DNA PCR undetectable in recent 12 months.

Exclusion criteria

  • Pregnant or breastfeeding, or has plan of pregnant during study period.
  • Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV), r HIV at screening visit.
  • Patient needs any anti-HBV treatment combination (add-on therapy) or switch to other anti HBV treatment from Telbivudine at investigator's discretion.
  • Patient has any laboratory value abnormality that physicians think he/she may not be suitable to continue the Telbivudine treatment.
  • Patient has any clinically significant concurrent severe or unstable disease conditions that physicians think he/she may have any additional risk or not be suitable to participate the study.
  • Patient has evidence of renal insufficiency defined as patient requiring dialysis or having an estimated creatinine clearance below 50mL/min, as estimated by the cockcroft-Gault formula.
  • Patient is currently abusing alcohol or illicit drugs.
  • Patient is enrolled or plans to enroll in another clinical trial of an investigational agent while participating in this study.
  • All other treatments for hepatitis B, including commercially available treatments indicated for conditions other than chronic hepatitis B that are being investigated to treat or may have activity against HBV (e.g., ribavirin, famciclovir, ganciclovir, etc.)
  • Prolonged use of systemic acyclovir or famciclovir defined as episodic treatment with these agents for periods exceeding 10 days every 3 months, or chronic suppressive therapy.
  • Systemic immunomodulators of any type.
  • Systemic corticosteroids ( topical and inhaled corticosteroids are permitted).
  • Herbal medications known to cause hepatotoxicity (e.g., St. John's Wart, Kava, Jin Bu Huan, Yuzhitang, germander, chaparral, shark cartilage, mistletoe, slim 10, Lipokinetix, etc.).

  • Patient has any of the following laboratory values:

    • Hemoglobin < 9 g/dL for menor <8 g/dL for women.
    • Total WBC <1,500/mm3
    • Absolute neutrophil count (ANC)<1,000/mm3
    • Platelet count <30,000/mm3
    • Serum albumin <2.5g/dL
    • Total bilirubin ≥4×ULN
    • Serum creatinine >1.5×ULN

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
600 mg/day, oral telbivudine for 52 weeks
Drug: Telbivudine
600 mg/day, oral telbivudine for 52 weeks
Other Names:
  • SEBIVO
  • TYZEKA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients experiencing serious adverse events (for all SAEs, and SAEs attributed to study drug). Proportion of patients experiencing adverse events, coded by body system ( all AEs, and AEs attributed to study drug).
Time Frame: At Baseline, Week 24 and Week 52
At Baseline, Week 24 and Week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
For HBeAg-positive patients, Maintained Virologic Response, here defined as HBeAg loss and serum HBV DNA PCR negative (COBAS Amplicor PCR < 300 copies/ml) during the whole study period.
Time Frame: At Baseline, Week 24 and Week 52
At Baseline, Week 24 and Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 27, 2008

First Posted (Estimate)

March 28, 2008

Study Record Updates

Last Update Posted (Actual)

June 22, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLDT600ACN04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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