Chronic Hepatitis
Conditions
Keywords
genotypes 2 and 3, combination treatment, individualized treatment
Brief 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.
Detailed description
The investigators are going to compare weight-based dosages of ribavirin, in combination with Peginterferon alpha-2a, with standard fixed dosages of 800 mg. Patients will be evaluated at week 4 with an assay of sensitivity of 15 IU/ml. Patients with week 4 response will discontinue treatment at week 12 in both arms. Patients with HCV RNA still detectable at week 4 and receiving 1000-1200 mg of ribavirin in arm A will discontinue treatment at week 24, whereas patients with HCV RNA still detectable at week 4 and receiving 800 mg of ribavirin in arm B will be treated till week 48. A standard treatment arm (C) including patients treated for 24 weeks with Peginterferon alpha-2a and fixed 800 mg ribavirin dosage will be used as control arm.
Interventions
DRUGPeginterferon 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
Casa di Cura Mater Dei
IRCCS L. Spallanzani
Ospedale Francesco Ferrari
Azienda Ospedaliero Universitaria di Sassari
Fondazione IRCCS Policlinico San Matteo di Pavia
Arcispedale S. Anna, Ferrara
Azienda Ospedaliero-Universitaria, Catania
Ospedale di Venosa
Ospedale Monsignor R. Dimiccoli, Barletta
IRCCS De Bellis, Castellana
USL Napoli 1
Ospedale San Giuseppe Moscati, Avellino
Cardarelli Hospital
Ospedale Civile Vittorio Emanuele II, Bisceglie
Azienda Ospedaliero-Universitaria Careggi
Azienda Ospedaliera V. Cervello
Ospedale Civile Spirito Santo
Ospedale di Canosa di Puglia
University of Palermo
San Camillo Hospital, Rome
Campus Bio-Medico University
Ospedale Sandro Pertini, Roma
Ospedali Riuniti di Foggia
Ospedale SS. Annunziata, Taranto
Ospedale di Mottola
Ospedale Santa Caterina Novella, Galatina
University of Florence
Ospedale Valduce, Como
University of Bari
Azienda Ospedaliera, Siracusa
Azienda Ospedaliera, Lucca
Casa Sollievo della Sofferenza IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained virological Response (SVR) | 6 months after the end of treatment | The primary measure of efficacy will be HCV RNA not detectable in serum samples 24 weeks after the end of therapy (SVR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rapid virological response (RVR) | On treatment week 4 | proportion of patients with undetectable HCV RNA 4 weeks after the start of treatment |
Countries
Italy
Outcome results
None listed