Treatment in HBeAg-negative chronic hepatitis B patients MedDRA version: 16.0 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
Current Sponsor code: LDT600
Other descriptive name: Sebivo
Concentration unit: mg mil
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Documented compensated HBeAg negative CHB defined by all of the following: •Detectable serum HBsAg at the screening visit and at least 6 months prior to the screening visit •HBeAg negative at the screening visit with positive HBeAb •Serum HBV DNA > 2000 IU/mL, as determined by the COBAS Taqman HBV DNA PCR assay at the central laboratory at screening visit •Serum ALT level > 1×ULN and 1×ULN within the last 6 months (EASL guidelines 2009; Lok and McMahon 2009) •Available liver histology report within 12 months before screening with diagnosis of chronic hepatitis B. Patients without evaluable liver histology report within 12 months of screening are eligible if: 1) they have clinical evidence of compensated liver cirrhosis; or 2) non-invasive methods which are recommended by guidelines and updated clinical practice and that support diagnosis of moderate to severe liver inflammation and/or fibrosis (i.e. Fibroscan) (EASL guidelines 2009; Lok and McMahon 2009) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. •Sexually active males must use a condom during intercourse while taking study drug and for 12 days after stopping study medication and should not father a child in this period. •Patients co-infected with HCV, HDV, or HIV. •Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time. •Patient has received IFN or other immunomodulatory treatment within six months before the screening visit. Precluded therapies include, but are not limited to any exposure to interferons, Thymosin, IL-12, or any types of immunological therapy. •Patient has a medical condition that requires frequent use of systemic acyclovir or famcyclovir, etc. •Patient has a medical condition that requires frequent use of systemic corticosteroids, however topical and inhaled corticosteroids are allowed. •Patient has clinical signs/symptoms of hepatic decompensation with Child-Pugh score of B or C. •History of malignancy of any organ system •Patient has one or more additional known primary or secondary causes of liver disease, other than CHB, including severe steatohepatitis and autoimmune hepatitis among other liver diseases. •Patient is currently abusing illicit drugs, or has a history of illicit substance abuse within the preceding two years. •Patients with a history of alcohol abuse will be required to be abstinent from alcohol 6 months prior to screening or at the investigator’s discretion, and during the course of the study. •Patients without a history of alcohol abuse with alcohol consumption of >30g ethanol/day for men and >15g ethanol/day for women twice a week during the course of the study. •Patient has a history of clinical and laboratory evidence of chronic renal insufficiency defined as an estimated serum creatinine clearance < 50 mL/min using either Cockcroft-Gault or MDRD; or with a lower serum phosphate < 1.5 mg/dL. •Patient has a medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs. •Patient has a medical condition requiring the use of chemotherapy. •History of any other acute or chronic medical condition that in the opinion of the investigator would make the patient unsuitable for inclusion into the study. •Patient has any other concomitant medical or social condition likely to preclude compliance with the schedule of evaluations in the protocol, or likely to confound the efficacy or safety observations of the study. •Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. •Patient has a history of myopathy, myositis, or persistent muscle weakness. •Patient has any of the following laboratory values during the screening period: •Hemoglobin =11 g/dL(110g/L) for men or =10 g/dL (100g/L) for women • Total WBC =3500/mm3 (3.5× 109 /L) • Absolute neutrophil count (ANC) =1,500/mm3 (1.5×109/L) • Platelet count = 75,000/mm3 (75× 109 /L) • Serum amylases or lipase = 2 × ULN
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to compare the efficacy of Roadmap-Concept-based telbivudine treatment versus Roadmap-Concept-based tenofovir treatment in HBeAg-negative CHB patients. The rate of HBV DNA < 300 copies/mL (51 IU/mL) at week 52 will be used for the comparison of the efficacy. The hypothesis is that the aggregated rate of HBV DNA <300 copies/mL (51 IU/mL) at week 52 of Telbivudine (ARM 1) is non-inferior to Tenofovir (ARM 2).;Secondary Objective: The key secondary objective of the study is to assess the antiviral efficacy, as evaluated by rate of patients achieving HBV DNA < 300 copies/mL (51 IU/mL) at Week 104.;Primary end point(s): Primary efficacy endpoint is the rate of HBV DNA < 300 copies/mL at week 52.;Timepoint(s) of evaluation of this end point: Week 52 | — |
Countries
Austria, Bulgaria, Germany, Greece, Italy, Russian Federation, Spain, Turkey
Contacts
Public ContactProject Manager
PPD
Outcome results
None listed