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NCT Number: NCT01380938

Different Ribavirin Dosages and Different Duration of Treatment in Combination With PegInterferon in Patients With Genotype 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.

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Key information

Conditions

Chronic Hepatitis Chronic Disease Digestive System Diseases Disease Attributes Hepatitis Hepatitis, Chronic Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Infectious Diseases Unit, Avellino, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peginterferon alpha-2a + Ribavirin

Drug

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. Rapid virological response (RVR)

    Time frame: On treatment week 4

    proportion of patients with undetectable HCV RNA 4 weeks after the start of treatment

Sponsors and collaborators

Lead sponsor

Casa Sollievo della Sofferenza IRCCS

Other

Collaborators

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

Registry information

Official study title

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

Acronym: WRITE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 27, 2011
Registry last updated
Mar 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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