Combined therapy with Adefovir and Interferon-Pegylated alfa 2a vs Adefovir alone, in patients affected by chronic hepatitis B, HbeAg negative (The PAC (Peg Adefovir Combination) Study). - PAC

AZIENDA OSPEDALIERA DI CASERTA0 个研究点开始时间: 2008年9月26日最近更新: 2012年3月19日

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•Age ≥18 and ≤65 years. Male and female patients HBsAg-positive, HBeAg negative, and anti-HBe-positive patients. HBV-DNA >104 copies/mL (chronic hepatitis B) or > 103 copies/mL (compensated hepatic cirrhosis) High transaminases levels in the last twelve months (ALT > 1,5 x UNL) with continuous or intermittent pattern (at least two positive determinations in last the twelve months). Chronic hepatitis or hepatic cirrhosis Class A CPT, MELD score N/A. Histological diagnosis through biopsy in the18 months following enrolment. It is not demanded for patients with previous histological or clinical evidence of hepatic cirrhosis
•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) no
•F.1.3.1 Number of subjects for this age range

•HBsAg/HBeAg positive subjects Anti-HDV positive subjects Anti-HCV and/or anti-HIV positive subjects Alcohol abuse (>40 gr of alcohol/day for men and 30 gr/day for women) in the last 5 years. Active abuse of drugs for intravenous way (ev) Transaminases levels within the normal range Viremia: HBV <104 copies/ml for chronic hepatitis diagnosis and <103 copies/ml for hepatic cirrhosis diagnosis Treatment with alfa-IFN (standard or pegylated), LAM, ADV, alone or in combination therapy, in the last six months. Serum HBV ADV-resistant mutant pre-treatment, even if ADV has been interrupted for more than six months Contraindications to Adefovir and/or Interferon Decompensated cirrhosis compensated hepatic cirrhosis with gastro-oesophageal varices>F1. HCC diagnosis Pregnancy and breast feeding Concomitant severe diseases (neoplasm, auto-immune disease, kidney pathology with creatininemia > 1.5 mg/dL, psychiatric disorders, any other severe organ pathology) Organ or bone marrow transplantation Recent systemic treatment with steroids, immunosuppressors

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