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

Active, not recruiting

Conditions: Patients affected by chronic hepatitis B, HbeAg negative
MedDRA version: 9.1Level: LLTClassification code 10008910Term: Chronic hepatitis B

Registration Number: EUCTR2007-005332-83-IT

Lead Sponsor: AZIENDA OSPEDALIERA DI CASERTA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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