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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Casa Sollievo della Sofferenza IRCCS.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Casa di Cura Mater Dei
IRCCS L. Spallanzani
Ospedale Francesco Ferrari, Casarano
Azienda Ospedaliero Universitaria di Sassari
IRCCS Policlinico S. Matteo
Arcispedale S. Anna, Ferrara
Azienda Ospedaliero-Universitaria, Catania
Ospedale di Venosa
Ospedale 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
Information provided by (Responsible Party):
Alessandra Mangia, Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier:
NCT01380938
First received: June 23, 2011
Last updated: April 14, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis
Drug: Peginterferon alpha-2a + Ribavirin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: RCT Comparing Different Ribavirin Dosages and Durations of Treatment in Combination With Peginterferon in HCV Genotypes 2 and 3 (WRITE)

Resource links provided by NLM:


Further study details as provided by Casa Sollievo della Sofferenza IRCCS:

Primary Outcome Measures:
  • Sustained virological Response (SVR) [ Time Frame: 6 months after the end of treatment ] [ Designated as safety issue: No ]
    The primary measure of efficacy will be HCV RNA not detectable in serum samples 24 weeks after the end of therapy (SVR).


Secondary Outcome Measures:
  • Rapid virological response (RVR) [ Time Frame: On treatment week 4 ] [ Designated as safety issue: No ]
    proportion of patients with undetectable HCV RNA 4 weeks after the start of treatment


Estimated Enrollment: 1150
Study Start Date: October 2010
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm C. Standard duration

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.

Experimental: Arm A

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)

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)

Other Names:
  • Peginterferon alpha-2a (40 kD) PEGASYS
  • Copegus or Rebetol, Ribavirin Teva
Experimental: Arm B

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)

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)

Other Names:
  • Peginterferon alpha-2a (40 kD) PEGASYS
  • Copegus or Rebetol, Ribavirin Teva

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01380938

Contacts
Contact: Alessandra Mangia, MD +39-0882-416270 a.mangia@operapadrepio.it

Locations
Italy
Infectious Diseases Unit Recruiting
Avellino, Italy
Contact: Patrizia Maio, MD         
Infectious Diseases Unit Recruiting
Avellino, Italy
Contact: Salvatore D'Angelo         
Clinical Medicine Unit "Mater Dei" Recruiting
Bari, Italy
Contact: Ernesto Agostinacchio, MD         
Università di Bari Recruiting
Bari, Italy
Contact: Franco Dammacco, MD         
Medicine Unit Recruiting
Barletta, Italy
Contact: Giuseppe Cuccorese, MD         
Infectious Diseases Unit "V. Emanuele" Recruiting
Bisceglie, Italy
Contact: Ruggiero Francavilla, MD         
Medicine Unit Recruiting
Canosa di Puglia, Italy
Contact: Nicola Minerva, MD         
Hepatology Unit Recruiting
Casarano, Italy
Contact: Donato Bacca, MD         
IRCCS "De Bellis" Recruiting
Castellana, Italy
Contact: Raffaele Cozzolongo, MD         
Infectious Diseases Unit Recruiting
Catania, Italy
Contact: Luciano Nigro, MD         
Hepatology Unit Recruiting
Catania, Italy
Contact: Maurizio Russello, MD         
Gastroenterology Unit Recruiting
Como, Italy
Contact: Giancarlo Spinzi, MD         
Gastroenterology Unit Arcispedale "S. Anna" Recruiting
Ferrara, Italy
Contact: Boccia Sergio, MD         
Internal Medicine University of Firenze Recruiting
Firenze, Italy
Contact: Anna L Zignego, MD         
Gastroenterology Unit Recruiting
Firenze, Italy
Contact: Paolo Forte, MD         
Gastroenterology Unit Recruiting
Foggia, Italy
Contact: Francesco Vinelli, MD         
Infectious Diseases Recruiting
Foggia, Italy
Contact: Gaetano Scotto, MD         
Gastroenterology Unit Recruiting
Galatina, Italy
Contact: Paolo Tundo, MD         
Infectious Diseases Recruiting
Lucca, Italy
Contact: Sauro Luchi, MD         
Gastroenterology Unit Recruiting
Mottola, Italy
Contact: Antonio Termite, MD         
Gastroenterology Unit "Cardarelli" Recruiting
Napoli, Italy
Contact: Giovanni Di Costanzo, MD         
USL Napoli 1 Recruiting
Napoli, Italy
Contact: Mario Colucci, MD         
Medical Clinic University of Palermo Recruiting
Palermo, Italy
Contact: Giuseppe Montalto, MD         
Hospital "V. Cervello" Recruiting
Palermo, Italy
Contact: Salvo Madonia, MD         
Infectious Diseases Unit IRCCS "San Matteo" Recruiting
Pavia, Italy
Contact: Giorgio Barbarini, MD         
Ospedale "Villa Betania" Recruiting
Roma, Italy
Contact: Mecenate Fabrizio, MD         
Campus Biomedico University Recruiting
Roma, Italy
Contact: Antonio Picardi, MD         
Hepatology Unit "S. Pertini" Recruiting
Roma, Italy
Contact: Mario Romano, MD         
Hepatology Unit "san Camillo" Recruiting
Roma, Italy
Contact: Adriano Pellicelli, MD         
IRCCS "L. Spallanzani" Recruiting
Rome, Italy
Contact: Pasquale Narciso, MD         
IRCCS "Casa Sollievo della Sofferenza" Recruiting
San Giovanni Rotondo, Italy, 71013
Contact: Alessandra Mangia, MD    +39-0882-416270    a.mangia@operapadrepio.it   
Contact: Leonardo Mottola, PhD    +39-0882-416271    leonardomottola@yahoo.it   
Infectious Diseases Unit Ospedale Civile Recruiting
Sassari, Italy
Contact: Sergio Baudieri, MD         
Medicine Unit Recruiting
Sassari, Italy
Contact: Franco Bandiera, MD         
Infectious Diseases Recruiting
Siracusa, Italy
Contact: Gaetano Scifo, MD         
SS. Annunziata Recruiting
Taranto, Italy
Contact: Fernando Sogari, MD         
Medicine Unit Recruiting
Venosa, Italy
Contact: Vito Carretta, MD         
Sponsors and Collaborators
Casa Sollievo della Sofferenza IRCCS
Casa di Cura Mater Dei
IRCCS L. Spallanzani
Ospedale Francesco Ferrari, Casarano
Azienda Ospedaliero Universitaria di Sassari
IRCCS Policlinico S. Matteo
Arcispedale S. Anna, Ferrara
Azienda Ospedaliero-Universitaria, Catania
Ospedale di Venosa
Ospedale 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
Investigators
Study Director: Alessandra Mangia, MD IRCCS "Casa Sollievo della Sofferenza"
  More Information

Publications:
Responsible Party: Alessandra Mangia, MD, Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier: NCT01380938     History of Changes
Other Study ID Numbers: EPAT-01-2010
Study First Received: June 23, 2011
Last Updated: April 14, 2012
Health Authority: Italy: Ministry of Health

Keywords provided by Casa Sollievo della Sofferenza IRCCS:
genotypes 2 and 3
combination treatment
individualized treatment

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 01, 2014