Treatment with Peg-interferon alfa-2a and ribavirin in patients with hepatitis HCV-related, with or without HIV co-infection, and end stage renal disease on dialysis - ND

• Conditions: Chonic hepatitis HCV-related; MedDRA version: 9.1Level: SOCClassification code 10019805; MedDRA version: 9.1Level: SOCClassification code 10038359

• Registration Number: EUCTR2010-023245-30-IT
• Lead Sponsor: ISTITUTO NAZIONALE DELLE MALATTIE INFETTIVE LAZZARO SPALLANZANI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-24
• Last Update Posted: 23 May 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Chronic hepatitis C
- End stage renal disease(eGFR < 50ml/min/1.73 mq di s.c.) in dialysis;
- Possibility to enter a transplantation list;
- Absence of pregnancy or breastfeeding;
- signature of informed consent;
- availability to use appropiate contraceptive method.
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

- Age< 18 years or >65 years;
- Patients oin treatment with immunomodulant or antineoplastic drugs;
- cirrhosis;
- Hematopoietic system disorders;
- Baseline Hb<8 gr/dl and/or Neutrophyls count<1000/mmc and/or platelet count<100000/mmc;
- History of epilepsy, psychiatric disorders, cardiovascular diseases in the last 6 months befor study entry, decompensated diabetes, respiratory disorders;
- Immunologic diseases that require steroid therapy;
- Ocular diseases;
- Acute infectious diseases;
- Transplanted patients;
- Allergy to study drugs.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified