None listed
Conditions
Interventions
Lobucavir Type of group
400 mg lobucavir QD is administered for 45 weeks
Group name:Interferon Type of group
Placebo QD PO is administered for 8 weeks, then placebo QD PO + 10 MU of Interferon TIW sc isadministered for 16 weeks and finally placebo QD PO is administered for 24 more weeks.
Sponsors
BRISTOL MYERS SQUIBB PERÚ S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: • Men or women over 16 years of age with chronic hepatitis B infection who have not received more than 2 weeks of prior therapy with interferon alfa or other agents with anti-HBV activity (eg, adefovir, lamivudine, famciclovir, or thymosin) . • Documented chronic hepatitis B, namely: A. AgHBs in serum for> 24 weeks B. AgHBe in serum for 12 weeks C. HBV DNA> 3 MEq / ml (10.7 pg / ml) by the method of hybridization of the D. Chiron´s DNAb, on two determinations separated by at least 4 weeks. • Liver biopsy demonstrating histopathology consistent with chronic hepatitis B, within the year prior to enrollment. Subjects whose biopsies demonstrate cirrhosis will also be eligible, provided they have compensated liver disease. • Subjects must have compensated liver disease according to the following criteria: • Protombine time 3.0 g / dl B. Bilirubin <3 mg / dl C. ALT (SGPT) between the range of 1.3 to 7.5 x the upper limit of normal • Serum level of alpha fetoprotein £ 20 ng / ml. (Subjects with a high alpha fetoprotein level can be enrolled if a repeated value obtained 4 weeks later does not demonstrate a continuous elevation of the alpha fetoprotein level, and if the ultrasound or computed tomography (CT) of the liver performed prior to enrollment do not show a focal lesion suggesting carcinoma). • All potentially fertile women (WOCBP) must have obtained a negative result in the pregnancy test performed in serum or urine (minimum sensitivity 25 IU / I of p-HCG) 48 hours before the start of the study medication.
Exclusion criteria
Exclusion criteria: • Have received immunosuppressive therapy (including systemic spheroids at doses> 20 mg daily of prednisone or equivalent) or agents with activity against hepatitis B, within 24 weeks before admission to the study • HIV infection according to antecedents, physical examination or serological tests • Serum creatinine> 1.5 x the normal upper limit • Hemoglobin 1.3 x the upper normal limit, or clinical symptoms of pancreatitis, or recent history of pancreatitis (within 24 weeks) • History or evidence of hepatic encephalopathy, high digestive hemorrhage due to varicose veins, or significant ascites (requiring diuretics or paracentesis) • Subjects with other forms of liver disease according to history, liver biopsy or serological tests (eg, coinfection with hepatitis C or • Known history of hepatocellular carcinoma, or physical or radiographic evidence of a liver mass • Previous treatment with lobucavir • Current abuse of alcohol or drugs • History of psychiatric condition, especially depression, since interferon can exacerbate these conditions. • Sexually active subjects who are not surgically sterile are reluctant to practice a safe method of contraception (oral, injectable or implantable contraceptive drugs, intrauterine device) • (IUD), diaphragm or prophylactic with jelly or spermicidal ointment, or sexual abstinence) during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Reduce HBV or HBeAg DNA titers to undetectable levels in serum by the end of the 48 weeks of the dosing period The proportion of patients who have a sustained response (HBV DNA or non-detectable HBeAg) 24 weeks after completing the dosing Measure:Efficacy Timepoints:24 to 48 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical observations and laboratory data collected from the time of the initial dose, during the dosage, and for 24 weeks after completing the dosage will be compared with the baseline pre-dose values established. If toxicities are observed, we will try to discern if they are related, possibly related, or not related to the administration of the study drug. Measure:Safety Timepoints:During dosing and after 24 weeks of completion. | — |
Outcome results
None listed