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临床试验/PER-050-99
PER-050-99已完成未知

RANDOMIZED, PARTIALLY BLIND STUDY, ON THE COMBINATION OF ORAL LOBUCAVIR INTERFERED ALPHACOMPARED WITH ALPHA INTERFERON AS MONOTHERAPY, OR LOBUCAVIR AS MONOTHERAPY, IN SUBJECTS CHRONICLY INFECTED WITH HEPATITIS B VIRUS

BRISTOL MYERS SQUIBB PERÚ S.A.,0 个研究点目标入组 0 人开始时间: 1998年5月1日最近更新:
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适应症

试验速览

阶段
未知
状态
已完成
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • •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 seconds longer than normal control
  • •A. Serum albumin> 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.

排除标准

  • •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 <10.0 g / dl
  • •Platelet count <70,000 / mm ^
  • •Absolute granulocyte count <1,500 cells / mm ^
  • •Lipase> 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.

研究者

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