Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B

Phase 1

• Conditions: chronic hepatitis B; MedDRA version: 19.0Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-001444-20-Outside-EU/EEA
• Lead Sponsor: Beijing Novartis Pharma Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05-18
• Last Update Posted: 23 May 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 2211

Inclusion Criteria

•Male or female 16 to 65 year of age
•Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
•Willing and able to comply with the study drug regimen
•Written informed consent before any assessment

Are the trial subjects under 18? yes
Number of subjects for this age range: 26
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2153
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

•Patient has a history of/or clinical signs/symptoms of hepatic decompensation
•Patient has a history of HCC or findings suggestive of possible HCC
•Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
•History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
•Patient has received IFN or other immunomodulatory treatment with 12 months before screening
•Previous treatment history with NRTIs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified