Different Ribavirin Dosages and Different Duration of Treatment in Combination With PegInterferon in Patients With Genotype 2 and 3 (WRITE)

• Status: Unknown status
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

WRITE study aim at identifying the effectiveness of an innovative individualized schedule of treatment as compared to standard regimen in patients with chronic HCV genotype 2 and 3.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Casa Sollievo della Sofferenza IRCCS
• Collaborators: Arcispedale S. Anna, Ferrara; Azienda Ospedaliera V. Cervello; Azienda Ospedaliera, Lucca; Azienda Ospedaliera, Siracusa; Azienda Ospedaliero Universitaria di Sassari; Azienda Ospedaliero-Universitaria Careggi; Azienda Ospedaliero-Universitaria, Catania; Campus Bio-Medico University; Cardarelli Hospital; Casa di Cura Mater Dei; IRCCS De Bellis, Castellana; IRCCS L. Spallanzani; IRCCS Policlinico S. Matteo; Ospedale Civile Spirito Santo; Ospedale Civile Vittorio Emanuele II, Bisceglie; Ospedale di Canosa di Puglia; Ospedale di Mottola; Ospedale di Venosa; Ospedale Francesco Ferrari; Ospedale Monsignor R. Dimiccoli, Barletta; Ospedale R. Dimiccoli, Barletta; Ospedale San Giuseppe Moscati, Avellino; Ospedale Sandro Pertini, Roma; Ospedale Santa Caterina Novella, Galatina; Ospedale SS. Annunziata, Taranto; Ospedale Valduce, Como; Ospedali Riuniti di Foggia; San Camillo Hospital, Rome; University of Bari; University of Florence; University of Palermo; USL Napoli 1
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Patients with chronic hepatitis C virus (HCV) infection (both HCVAb and HCV RNA positive)

• Patients with HCV genotype 2 or 3

• Age 18-70 years

• Naïve patients or previously treated only with standard interferon monotherapy

• Female patients of childbearing age who agree to avoid pregnancy during the period of treatment and 24 weeks after the end of treatment

Exclusion Criteria:

• Previous treatment with ribavirin

• Cirrhosis (CHILD PUGH B and C)

• Evidence of Hepatocellular carcinoma

• Pregnancy

• Retinopathy class I or II

• Alcohol consumption > 40 gr/day

• Chronic cardiac or respiratory diseases

• HIV or HBsAg or HDV positivity

• Hemoglobin < 8.5 gr/dL

• WBC < 3.500/mm3

• PLT < 80.000/mm3