A randomized, open-label, controlled, mutli-center two-year study comparing efficacy and safety of telbivudine (LDT600) 600 mg PO in combination with peg alpha-2a sq 180 µg with peg alpha-2a montherapy, and with telbivudine monotherapy in treatment naïve patients with HBeAg-positive CHB
- Conditions
- Treatment of naïve patients with HBeAg-positive compensated chronic hepatitis BMedDRA version: 8.1Level: LLTClassification code 10008910Term: Chronic hepatitis B
- Registration Number
- EUCTR2006-004003-18-FR
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
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 = 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.
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
1.Co-infection with HCV, HDV, or HIV.
2.Has any of the following drug therapy:
•Previously been treated in a trial with telbivudine
•Received nucleoside or nucleotide therapy whether approved or investigational.
•Received any immunomodulatory treatment in the 12 months before Screening for this study. Has a medical condition that required prolonged or frequent use of systemic acyclovir or famciclovir. 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.
•Is currently abusing alcohol or illicit drugs or has a history of alcohol abuse illicit substance abuse within the preceding two years.
•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 methodone.
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
- History of hyper sensitivity toahy of the study drugs with similar chemical structures or their excipients
- Pregnant or breastfeeding
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 = 1.5 x ULN
•Serum albumin <3.3 g/dL
•Total bilirubin = 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;
•AFP > 50 ng/mL
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method