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

RCT Comparing Different Ribavirin Dosages and Durations of Treatment in Combination With Peginterferon in HCV Genotypes 2 and 3 (WRITE)

Sponsors

Lead Sponsor: Casa Sollievo della Sofferenza IRCCS

Collaborator: Casa di Cura Mater Dei
IRCCS L. Spallanzani
Ospedale Francesco Ferrari
Azienda Ospedaliero Universitaria di Sassari
IRCCS Policlinico S. Matteo
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

Source Casa Sollievo della Sofferenza IRCCS
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.

Overall Status Unknown status
Start Date 2010-10-01
Completion Date 2012-08-01
Primary Completion Date 2012-08-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Sustained virological Response (SVR) 6 months after the end of treatment
Secondary Outcome
Measure Time Frame
Rapid virological response (RVR) On treatment week 4
Enrollment 1150
Condition
Intervention

Intervention Type: Drug

Intervention Name: Peginterferon alpha-2a + Ribavirin

Description: 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)

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Alessandra Mangia, MD Study Director IRCCS "Casa Sollievo della Sofferenza"
Overall Contact

Last Name: Alessandra Mangia, MD

Phone: +39-0882-416270

Email: [email protected]

Location
Facility: Status: Contact:
Infectious Diseases Unit | Avellino, Italy Recruiting Salvatore D'Angelo
Infectious Diseases Unit | Avellino, Italy Recruiting Patrizia Maio, MD
Clinical Medicine Unit "Mater Dei" | Bari, Italy Recruiting Ernesto Agostinacchio, MD
Università di Bari | Bari, Italy Recruiting Franco Dammacco, MD
Medicine Unit | Barletta, Italy Recruiting Giuseppe Cuccorese, MD
Infectious Diseases Unit "V. Emanuele" | Bisceglie, Italy Recruiting Ruggiero Francavilla, MD
Medicine Unit | Canosa di Puglia, Italy Recruiting Nicola Minerva, MD
Hepatology Unit | Casarano, Italy Recruiting Donato Bacca, MD
IRCCS "De Bellis" | Castellana, Italy Recruiting Raffaele Cozzolongo, MD
Hepatology Unit | Catania, Italy Recruiting Maurizio Russello, MD
Infectious Diseases Unit | Catania, Italy Recruiting Luciano Nigro, MD
Gastroenterology Unit | Como, Italy Recruiting Giancarlo Spinzi, MD
Gastroenterology Unit Arcispedale "S. Anna" | Ferrara, Italy Recruiting Boccia Sergio, MD
Gastroenterology Unit | Firenze, Italy Recruiting Paolo Forte, MD
Internal Medicine University of Firenze | Firenze, Italy Recruiting Anna L Zignego, MD
Gastroenterology Unit | Foggia, Italy Recruiting Francesco Vinelli, MD
Infectious Diseases | Foggia, Italy Recruiting Gaetano Scotto, MD
Gastroenterology Unit | Galatina, Italy Recruiting Paolo Tundo, MD
Infectious Diseases | Lucca, Italy Recruiting Sauro Luchi, MD
Gastroenterology Unit | Mottola, Italy Recruiting Antonio Termite, MD
Gastroenterology Unit "Cardarelli" | Napoli, Italy Recruiting Giovanni Di Costanzo, MD
USL Napoli 1 | Napoli, Italy Recruiting Mario Colucci, MD
Hospital "V. Cervello" | Palermo, Italy Recruiting Salvo Madonia, MD
Medical Clinic University of Palermo | Palermo, Italy Recruiting Giuseppe Montalto, MD
Infectious Diseases Unit IRCCS "San Matteo" | Pavia, Italy Recruiting Giorgio Barbarini, MD
Campus Biomedico University | Roma, Italy Recruiting Antonio Picardi, MD
Hepatology Unit "S. Pertini" | Roma, Italy Recruiting Mario Romano, MD
Hepatology Unit "san Camillo" | Roma, Italy Recruiting Adriano Pellicelli, MD
Ospedale "Villa Betania" | Roma, Italy Recruiting Mecenate Fabrizio, MD
IRCCS "L. Spallanzani" | Rome, Italy Recruiting Pasquale Narciso, MD
IRCCS "Casa Sollievo della Sofferenza" | San Giovanni Rotondo, 71013, Italy Recruiting Alessandra Mangia, MD +39-0882-416270 [email protected]
Infectious Diseases Unit Ospedale Civile | Sassari, Italy Recruiting Sergio Baudieri, MD
Medicine Unit | Sassari, Italy Recruiting Franco Bandiera, MD
Infectious Diseases | Siracusa, Italy Recruiting Gaetano Scifo, MD
SS. Annunziata | Taranto, Italy Recruiting Fernando Sogari, MD
Medicine Unit | Venosa, Italy Recruiting Vito Carretta, MD
Location Countries

Italy

Verification Date

2012-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Casa Sollievo della Sofferenza IRCCS

Investigator Full Name: Alessandra Mangia

Investigator Title: MD

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Arm C. Standard duration

Type: No Intervention

Description: Patients will be randomly assigned in 3:3:1 ratio to three treatment arms. In the standard treatment group (Arm C), patients will be treated for 24 weeks independently of the HCV RNA status at week 4 with Peginterferon alpha-2a at a dose of 180 mcg weekly in combination with oral ribavirin administered at a dosage of 800 mg/day. Patients enrolled in Arm C will be treated for standard 24 weeks duration of treatment.

Label: Arm A

Type: Experimental

Description: Patients enrolled in Arm A will receive Peginterferon alpha-2a at a dosage of 180 mcg weekly in combination with oral ribavirin administered at a dosage of 1000 mg/day for patients with a body weight < 75 kg or 1200 mg/day for those with a body weight > 75 kg. Patients with week 4 viral clearance (labelled as rapid virological responders, RVR) will be allocated to 12 week treatment duration (Arm A), whereas those without RVR will be treated for 24 weeks (Arm A)

Label: Arm B

Type: Experimental

Description: Patients enrolled in Arm B will receive Peginterferon alpha-2a at a dosage of 180 mcg weekly in combination with oral ribavirin administered at a dosage of 800 mg/day. Patients with week 4 viral clearance (labelled as rapid virological responders, RVR) will be allocated to 12 week treatment duration (Arm B), whereas those without RVR will be treated for 48 weeks (Arm B)

Acronym WRITE
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

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