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.
Information provided by:
Novartis Identifier:
First received: March 26, 2008
Last updated: June 16, 2011
Last verified: June 2011

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:


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

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
Please refer to this study by its identifier: NCT00646503

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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceticals 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
Polymerase Chain reaction

Additional relevant MeSH terms:
Hepatitis B, Chronic
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 processed this record on April 15, 2014