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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00646503
First received: March 26, 2008
Last updated: June 16, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Hepatitis B, Chronic
Drug: Telbivudine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
600 mg/day, oral telbivudine for 52 weeks
Drug: Telbivudine
600 mg/day, oral telbivudine for 52 weeks
Other Names:
  • SEBIVO
  • TYZEKA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646503

Locations
China
Novartis Investigative Site
Beijing, China
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceticals
ClinicalTrials.gov Identifier: NCT00646503     History of Changes
Other Study ID Numbers: CLDT600ACN04
Study First Received: March 26, 2008
Last Updated: June 16, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Novartis:
Hepatitis B, Chronic
Telbivudine
Polymerase Chain reaction

Additional relevant MeSH terms:
Hepatitis B, Chronic
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Telbivudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014