chronic hepatitis B MedDRA version: 19.0 Level: PT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Sebivo
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: TELBIVUDINE
CAS Number: 3424-98-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60
Sponsors
Beijing Novartis Pharma Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study was to evaluate the antiviral efficacy of Telbivudine with percentage of patients achieving HBV DNA<300 copies/mL at week 52.;Secondary Objective: The secondary objectives of the study were as follows: 1. To assess percentage of patients achieving HBV DNA<300 copies/mL at Week 24. 2. To assess the reduction in HBV DNA from baseline at Weeks 12, 24, 36 and 52. 3. To assess percentage of patients with HBeAg loss / seroconversion at Week 52 in HBeAg positive patients at baseline. 4. To assess percentage of patients with ALT normalization at Weeks 24 and 52 in patients with elevated ALT at baseline. 5. To assess percentage of patients with HBsAg loss / seroconversion at Week 52. 6. To assess percentage of patients with virologic breakthrough at Week 52. 7. To assess percentage of patients with treatment-emergent genotypically confirmed resistance associated with virologic breakthrough at Week 52. 8. To assess the safety endpoints, including incidence of clinical adverse events and graded laboratory abnormalities at Week 52.;Primary end point(s): HBV DNA PCR negativity rate ;Timepoint(s) of evaluation of this end point: At week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) HBV DNA PCR negativity rate 2) DNA reduction 3) HBeAg loss rate 4) HBeAg seroconversion rate 5) ALT normalization rate 6) Incidence of AE (SAE,etc), Graded lab abnormalities ;Timepoint(s) of evaluation of this end point: 1) At week 24 2) From baseline to weeks 12, 24, 36, 52 3) At week 52 4) At week 52 5) At weeks 24 and 52 6) At week 52 | — |
Countries
China
Contacts
Public ContactClinical Trial Information Desk
Novartis Pharma AG
Outcome results
None listed