Patients affected by chronic hepatitis B, HbeAg negative MedDRA version: 9.1 Level: LLT Classification code 10008910 Term: Chronic hepatitis B
Conditions
Interventions
Trade Name: HEPSERA
Pharmaceutical Form: Tablet
INN or Proposed INN: Adefovir dipivoxil
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Trade Name: PEGASYS*SC
Sponsors
AZIENDA OSPEDALIERA DI CASERTA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of study drug efficacy with respect to virological, serological, and histological response of combined therapy treatment with Peg-IFN alfa 2a (sc.)and Adefovir 10 mg/die for 48 weeks, followed by Adefovir 10 mg/die alone for further 96 weeks versus Adefovir 10 mg/die alone for 144 weeks in subjects with chronic hepatitis B, HBeAg negative;Secondary Objective: Biochemistry response- defined as transaminasis normalization; Serological response- defined as seroconversion to HBsAg negative or to anti-HBs positive; ccDNA intrahepatics levels reductions; Histological response- defined as at least 2 score points of the Histological Activity Index (according to Knodell) and at least 1 score point (according to Scheuer) of fibrosis reduction; Development of virological breakthrough (HBV-DNA increased over 1 log) Appearance of clinical events Evidence of N236T and A181V mutations;Primary end point(s): Evaluation of virological response, defined as serum HBV-DNA negativization investigated with High Sensitivity Real-time methods at weeks: 24, 48, 72, 96, 120, and 144 | — |
Countries
Italy
Outcome results
None listed