Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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
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   (Adult, Senior)
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

Locations
Italy
Infectious Diseases Unit
Avellino, Italy
Clinical Medicine Unit "Mater Dei"
Bari, Italy
Università di Bari
Bari, Italy
Medicine Unit
Barletta, Italy
Infectious Diseases Unit "V. Emanuele"
Bisceglie, Italy
Medicine Unit
Canosa di Puglia, Italy
Hepatology Unit
Casarano, Italy
IRCCS "De Bellis"
Castellana, Italy
Hepatology Unit
Catania, Italy
Infectious Diseases Unit
Catania, Italy
Gastroenterology Unit
Como, Italy
Gastroenterology Unit Arcispedale "S. Anna"
Ferrara, Italy
Gastroenterology Unit
Firenze, Italy
Internal Medicine University of Firenze
Firenze, Italy
Gastroenterology Unit
Foggia, Italy
Infectious Diseases
Foggia, Italy
Gastroenterology Unit
Galatina, Italy
Infectious Diseases
Lucca, Italy
Gastroenterology Unit
Mottola, Italy
Gastroenterology Unit "Cardarelli"
Napoli, Italy
USL Napoli 1
Napoli, Italy
Hospital "V. Cervello"
Palermo, Italy
Medical Clinic University of Palermo
Palermo, Italy
Infectious Diseases Unit IRCCS "San Matteo"
Pavia, Italy
Campus Biomedico University
Roma, Italy
Hepatology Unit "S. Pertini"
Roma, Italy
Hepatology Unit "san Camillo"
Roma, Italy
Ospedale "Villa Betania"
Roma, Italy
IRCCS "L. Spallanzani"
Rome, Italy
IRCCS "Casa Sollievo della Sofferenza"
San Giovanni Rotondo, Italy, 71013
Infectious Diseases Unit Ospedale Civile
Sassari, Italy
Medicine Unit
Sassari, Italy
Infectious Diseases
Siracusa, Italy
SS. Annunziata
Taranto, Italy
Medicine Unit
Venosa, Italy
Sponsors and Collaborators
Casa Sollievo della Sofferenza IRCCS
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 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
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 08, 2016