Status:
COMPLETED
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
Lead Sponsor:
Novartis
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will explore efficacy and safety of Telbivudine in the fifth year of treatment.
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00646503
Start Date
March 1 2008
End Date
September 1 2009
Last Update
June 22 2017
Active Locations (1)
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1
Novartis Investigative Site
Beijing, China