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

Novartis

Status and phase

Completed

Phase 4

Conditions

Hepatitis B, Chronic

Treatments

Drug: Telbivudine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00646503

CLDT600ACN04

Details and patient eligibility

About

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

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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