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

March 9, 2022 updated by: Alessandra Mangia, Casa Sollievo della Sofferenza IRCCS

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Avellino, Italy
        • Infectious Diseases Unit
      • Bari, Italy
        • Clinical Medicine Unit "Mater Dei"
      • Bari, Italy
        • Universita Di Bari
      • Barletta, Italy
        • Medicine Unit
      • Bisceglie, Italy
        • Infectious Diseases Unit "V. Emanuele"
      • Canosa di Puglia, Italy
        • Medicine Unit
      • Casarano, Italy
        • Hepatology Unit
      • Castellana, Italy
        • IRCCS "De Bellis"
      • Catania, Italy
        • Hepatology Unit
      • Catania, Italy
        • Infectious Diseases Unit
      • Como, Italy
        • Gastroenterology Unit
      • Ferrara, Italy
        • Gastroenterology Unit Arcispedale "S. Anna"
      • Firenze, Italy
        • Gastroenterology Unit
      • Firenze, Italy
        • Internal Medicine University of Firenze
      • Foggia, Italy
        • Gastroenterology Unit
      • Foggia, Italy
        • Infectious Diseases
      • Galatina, Italy
        • Gastroenterology Unit
      • Lucca, Italy
        • Infectious Diseases
      • Mottola, Italy
        • Gastroenterology Unit
      • Napoli, Italy
        • Gastroenterology Unit "Cardarelli"
      • Napoli, Italy
        • USL Napoli 1
      • Palermo, Italy
        • Hospital "V. Cervello"
      • Palermo, Italy
        • Medical Clinic University of Palermo
      • Pavia, Italy
        • Infectious Diseases Unit IRCCS "San Matteo"
      • Roma, Italy
        • Campus Biomedico University
      • Roma, Italy
        • Hepatology Unit "S. Pertini"
      • Roma, Italy
        • Hepatology Unit "san Camillo"
      • Roma, Italy
        • Ospedale "Villa Betania"
      • Rome, Italy
        • IRCCS "L. Spallanzani"
      • San Giovanni Rotondo, Italy, 71013
        • IRCCS "Casa Sollievo della Sofferenza"
      • Sassari, Italy
        • Infectious Diseases Unit Ospedale Civile
      • Sassari, Italy
        • Medicine Unit
      • Siracusa, Italy
        • Infectious Diseases
      • Taranto, Italy
        • Ss. Annunziata
      • Venosa, Italy
        • Medicine Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained virological Response (SVR)
Time Frame: 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).
6 months after the end of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rapid virological response (RVR)
Time Frame: On treatment week 4
proportion of patients with undetectable HCV RNA 4 weeks after the start of treatment
On treatment week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Casa Sollievo della Sofferenza IRCCS

Collaborators

University of Palermo
University of Florence
Campus Bio-Medico University
IRCCS Policlinico S. Matteo
Azienda Ospedaliero-Universitaria Careggi
University of Bari
San Camillo Hospital, Rome
Ospedale Sandro Pertini, Roma
Azienda Ospedaliero Universitaria di Sassari
Ospedale Civile Spirito Santo
Azienda Ospedaliera V. Cervello
Ospedali Riuniti di Foggia
Ospedale Valduce, Como
Ospedale Monsignor R. Dimiccoli, Barletta
Cardarelli Hospital
Ospedale Francesco Ferrari
Ospedale di Canosa di Puglia
Ospedale di Venosa
Ospedale SS. Annunziata, Taranto
Casa di Cura Mater Dei
IRCCS L. Spallanzani
Arcispedale S. Anna, Ferrara
Azienda Ospedaliero-Universitaria, Catania
IRCCS De Bellis, Castellana
USL Napoli 1
Ospedale San Giuseppe Moscati, Avellino
Ospedale Civile Vittorio Emanuele II, Bisceglie
Ospedale di Mottola
Ospedale Santa Caterina Novella, Galatina
Azienda Ospedaliera, Siracusa
Azienda Ospedaliera, Lucca

Investigators

  • Study Director: Alessandra Mangia, MD, IRCCS "Casa Sollievo della Sofferenza"

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2018

Primary Completion (ACTUAL)

November 30, 2019

Study Completion (ACTUAL)

November 30, 2019

Study Registration Dates

First Submitted

June 23, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (ESTIMATE)

June 27, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 24, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPAT-01-2010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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