A randomized, open-label, controlled, multi-center two-year study comparing efficacy and safety of telbivudine LDT600 600 mg PO in combination with peg alpha-2a sq 180 g with peg alpha-2a monotherapy, and with telbivudine monotherapy in treatment na ve patients with HBeAg-positive compensated CHB - ND

Conditions: CHB Chronic Hepatitis B
MedDRA version: 8.1Level: LLTClassification code 10019736Term: Hepatitis B antibody positive

Registration Number: EUCTR2006-004003-18-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

1. Male or female, at least 18 years of age. 2. Documented 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 History of evidence of chronic liver inflammation, documented by previous history of elevated serum ALT at least two elevated ALT values spanning six months or more, documented in available records Elevated serum ALT level 1.3 10 x upper limit of normal ULN at the Screening visit Serum HBV DNA level 8805; 6 log10 copies/mL, as determined by the COBAS Amplicor HBV PCR assay at the central study laboratory at Screening visit Chronic liver inflammation on previous liver biopsy within the previous 24 months in source documents. 3. Is willing and able to comply with the study drug regimen and all other study requirements. 4. 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures or their excipients. 2. Co-infection with HCV, HDV, or HIV. 3. Has any of the following drug therapy Previously been treated in a trial with telbivudine Received nucleoside or nucleotide therapy whether approved or investigational. See Appendix 3. Received any immunomodulatory treatment in the 12 months before Screening for this study.See Appendix 3. Has a medical condition that required prolonged or frequent use of systemic acyclovir or famciclovir. See Appendix 3. Has a medical condition that requires frequent or prolonged use of systemic corticosteroids although inhaled or intra-articular corticosteroids are allowed. Has a medical condition requiring the chronic or prolonged use of potentially hepatotoxic drugs or nephrotoxic drugs. Please refer to Appendix 3. Is currently abusing alcohol or illicit drugs or has a history of alcohol abuse illicit substance abuse within the preceding two years. See Appendix 3. Uses other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer. Is currently receiving methadone. 4. Patient has any of the following History of or clinical signs/symptoms of hepatic decompensation such as ascites, esophageal variceal bleeding, hepatic encephalopathy, or spontaneous bacterial peritonitis. 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 HCC should have the disease ruled out prior to entrance into the study. One or more additional known primary or secondary causes of liver disease other than hepatitis B, including steatohepatitis. Note Gilbert s syndrome and Dubin-Johnson syndrome are not considered exclusion criteria for this study. History of clinical and laboratory evidence of chronic pancreatitis, or demonstrates a clinical and laboratory course consistent with current pancreatitis. Has in the opinion of the investigator any other concurrent 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. If in the opinion of the investigator, the patient is at risk of developing a serious or life-threatening neuropsychiatric condition 5. Has any of the following laboratory values during Screening HGB 11 g/dL for men or 10 g/dL for women Total WBC 3,500/mm3 ANC 1,500.mm3 Platelet count 75,000/mm3 Serum amylase or lipase 8805; 1.5 x ULN Serum albumin 3.3 g/dL Total bilirubin 8805; 2.0 mg/dL ANA 1 320 Prothrombin Time 3 seconds despite vitamin K administration Estimated calculated serum creatinine clearance 50 mL/min using the Cockcroft-Gault method using actual or ideal body weight whichever is less; see Glossary of Terms Cockcroft and Gault 1976 AFP 50 ng/mL 6. Is pregnant or breastfeeding. Women of childbearing potential must have a negative serum 946;-HCG during Screening. 7. Is a 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 a