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

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.

Conditions

• Chronic Hepatitis

Interventions

DRUG

Peginterferon alpha-2a + Ribavirin

Administration of ribavirin at a dosage of 1000 or 1200 mg per day based on body weight \< or \> 75 kg for 24 weeks (Arm A). Treatment duration of 48 weeks with standard fixed dose of ribavirin (800 mg/day) (Arm B). These schedules will be compared with diagram of standard therapy with 800 mg daily of ribavirin for 24 weeks (Arm C)

Sponsors & Collaborators

• Casa di Cura Mater Dei

  collaborator UNKNOWN

• IRCCS L. Spallanzani

  collaborator UNKNOWN

• Ospedale Francesco Ferrari

  collaborator OTHER

• Azienda Ospedaliero Universitaria di Sassari

  collaborator OTHER

• Fondazione IRCCS Policlinico San Matteo di Pavia

  collaborator OTHER

• Arcispedale S. Anna, Ferrara

  collaborator UNKNOWN

• Azienda Ospedaliero-Universitaria, Catania

  collaborator UNKNOWN

• Ospedale di Venosa

  collaborator UNKNOWN

• Ospedale Monsignor R. Dimiccoli, Barletta

  collaborator OTHER

• IRCCS De Bellis, Castellana

  collaborator UNKNOWN

• USL Napoli 1

  collaborator UNKNOWN

• Ospedale San Giuseppe Moscati, Avellino

  collaborator UNKNOWN

• Cardarelli Hospital

  collaborator OTHER

• Ospedale Civile Vittorio Emanuele II, Bisceglie

  collaborator UNKNOWN

• Azienda Ospedaliero-Universitaria Careggi

  collaborator OTHER

• Azienda Ospedaliera V. Cervello

  collaborator OTHER

• Ospedale Civile Spirito Santo

  collaborator OTHER

• Ospedale di Canosa di Puglia

  collaborator UNKNOWN

• University of Palermo

  collaborator OTHER

• San Camillo Hospital, Rome

  collaborator OTHER

• Campus Bio-Medico University

  collaborator OTHER

• Ospedale Sandro Pertini, Roma

  collaborator OTHER

• Ospedali Riuniti di Foggia

  collaborator OTHER

• Ospedale SS. Annunziata, Taranto

  collaborator UNKNOWN

• Ospedale di Mottola

  collaborator UNKNOWN

• Ospedale Santa Caterina Novella, Galatina

  collaborator UNKNOWN

• University of Florence

  collaborator OTHER

• Ospedale Valduce, Como

  collaborator UNKNOWN

• University of Bari

  collaborator OTHER

• Azienda Ospedaliera, Siracusa

  collaborator UNKNOWN

• Azienda Ospedaliera, Lucca

  collaborator UNKNOWN

• Casa Sollievo della Sofferenza IRCCS

  lead OTHER

Principal Investigators

• Alessandra Mangia, MD · IRCCS "Casa Sollievo della Sofferenza"

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-12-01

Primary Completion

2019-11-30

Completion

2019-11-30

Countries

• Italy

Study Locations