Treatment of adult patients with HBeAg-positive chronic hepatitis B MedDRA version: 14.1 Level: LLT Classification code 10008910 Term: Chronic hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Sebivo 600 mg Filmtabletten
Product Name: Sebivo
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Telbivudin
CAS Number: 3424-98-4
Concentration unit: mg milligram(s)
Concentra
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet all of the following inclusion criteria: 1. Male or female, at least 18 years of age. 2. Documented HBeAg positive CHB defined by all of the following: • Clinical history compatible with CHB • Detectable serum HBsAg at the Screening visit and at least 6 months prior • HBeAg positive at the Screening visit • HBeAb negative at the Screening visit • Serum HBV DNA level = 5 log10 copies/mL, as determined by the COBAS Amplicor HBV PCR assay (LLOD = 300 copies / mL) at the central study laboratory at Screening visit • Evidence of chronic liver inflammation, documented by previous history of elevated serum ALT and /or AST levels (at least two elevated ALT or AST values spanning six months or more, documented in available records) with or without prior liver biopsy that is consistent with CHB • For patients with cirrhosis, clinical history compatible with compensated liver disease • Elevated serum ALT level (1.3 – 10 x ULN) at the Screening visit 3. Patient is willing and able to comply with the study drug regimen and all other study requirements. 4. The patient is willing and able to provide written informed consent to participate in the study. 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 103 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study for any of the following reasons: 1. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures. 2. Patient is pregnant or breastfeeding. 3. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means. The exception of the aforementioned criteria will be given if they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/ml (IU/L) or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or have been surgically sterilized (e.g., bilateral tubal ligation) or the patient must agree to use two methods of birth control. This is any combination of hormonal contraception (implantable, patch, oral or injection), IUD, male or female condom with spermicidal gel, diaphragm, sponge or cervical cap. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-HCG) during Screening. 4. Is a male who is capable of reproduction, defined as all men physiologically capable of producing sperm, including men whose career, lifestyle, or sexual orientation precludes intercourse with a female partner and men who have been sterilized (vasectomy) or whose partners have been sterilized by surgical bilateral oophorectomy with or without hysterectomy, bilateral tubal ligation or other means, UNLESS the female partner meets the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/ml (IU/L) or the patient must agree to use two methods of birth control. This is any combination of hormonal contraception (implantable, patch ,oral or injection), IUD, male or female condom with spermicidal gel, diaphragm, sponge or cervical cap. 5. Patient is co-infected with HCV, HDV, or HIV. 6. Patients who have previously been involved in a trial with telbivudine. 7. Patient has received nucleoside or nucleotide drugs whether approved or investigational at any time. 8. Patient has received IFN or other immunomodulatory treatment in the 6 months before Screening for this study. 9. Patient has a history of or clinical signs/symptoms of hepatic decompensation such as ascites, esophageal variceal bleeding, hepatic encephalopathy, hepatorenal syndrome, hepatic hydrothorax, hepatopulmonary syndrome or spontaneous bacterial peritonitis, among others. 10. Patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir. 11. Patient has a history of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin. Patients with previous findings suggestive of possible hepatocellular carcinoma (HCC), should have the disease ruled out prior to entrance into the study. 12. Patient has one or more additional known primary or secondary causes of liver disease other than CHB, including steatohepatitis and autoimmune hepatitis among other liver diseases. Gilbert’s syndrome and Dubin-Johnson syndrome are no
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine if telbivudine early non-responders can achieve an antiviral response with the addition of tenefovir;Secondary Objective: The key secondary objectives of the study are: 1. To estimate the rate of virologic breakthrough up to week 48 and week 104 2. To assess the rate of treatment-emergent genotypically confirmed HBV resistance associated with viral breakthrough up to weeks 48 and 104 Other secondary objectives of the study include: 3. Assessment of HBV DNA non-detectability, reduction in HBV DNA from baseline and sustained reduction in HBV DNA over the course of study 4. Assessment of HBeAg loss and HBeAg seroconversion (defined as loss of HBeAg and development of HBeAb) over course of study 5. To describe the ALT normalization rate at weeks 52 and 104 ;Primary end point(s): Proportion of patients (response rate) who achieve HBV DNA non-detectability at week 52 | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH, Medical Competence Center
Outcome results
None listed