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

NCT01380938 | Completed Phase 3

• 1 other identifier: EPAT-01-2010
• Study Type: interventional
• Target: 1,150
• Locations: 1 country
• Sites: 35

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.

Conditions

Chronic Hepatitis

Keywords

genotypes 2 and 3; combination treatment; individualized treatment

Outcome Measures

Primary Outcomes (1)

• Sustained virological Response (SVR)

  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 Outcomes (1)

• Rapid virological response (RVR)

  On treatment week 4

Study Arms (3)

Arm C. Standard duration

NO INTERVENTION

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.

Arm A

EXPERIMENTAL

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

Arm B

EXPERIMENTAL

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

Interventions

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)

Also known as: Peginterferon alpha-2a (40 kD) PEGASYS, Copegus or Rebetol, Ribavirin Teva

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (35)

Infectious Diseases Unit

Avellino, Italy

Location

Clinical Medicine Unit "Mater Dei"

Bari, Italy

Location

Università di Bari

Bari, Italy

Location

Medicine Unit

Barletta, Italy

Location

Infectious Diseases Unit "V. Emanuele"

Bisceglie, Italy

Location

Medicine Unit

Canosa di Puglia, Italy

Location

Hepatology Unit

Casarano, Italy

Location

IRCCS "De Bellis"

Castellana Grotte, Italy

Location

Hepatology Unit

Catania, Italy

Location

Infectious Diseases Unit

Catania, Italy

Location

Gastroenterology Unit

Como, Italy

Location

Gastroenterology Unit Arcispedale "S. Anna"

Ferrara, Italy

Location

Gastroenterology Unit

Florence, Italy

Location

Internal Medicine University of Firenze

Florence, Italy

Location

Gastroenterology Unit

Foggia, Italy

Location

Infectious Diseases

Foggia, Italy

Location

Gastroenterology Unit

Galatina, Italy

Location

Infectious Diseases

Lucca, Italy

Location

Gastroenterology Unit

Mottola, Italy

Location

Gastroenterology Unit "Cardarelli"

Napoli, Italy

Location

USL Napoli 1

Napoli, Italy

Location

Hospital "V. Cervello"

Palermo, Italy

Location

Medical Clinic University of Palermo

Palermo, Italy

Location

Infectious Diseases Unit IRCCS "San Matteo"

Pavia, Italy

Location

Campus Biomedico University

Roma, Italy

Location

Hepatology Unit "S. Pertini"

Roma, Italy

Location

Hepatology Unit "san Camillo"

Roma, Italy

Location

Ospedale "Villa Betania"

Roma, Italy

Location

IRCCS "L. Spallanzani"

Rome, Italy

Location

IRCCS "Casa Sollievo della Sofferenza"

San Giovanni Rotondo, 71013, Italy

Location

Infectious Diseases Unit Ospedale Civile

Sassari, Italy

Location

Medicine Unit

Sassari, Italy

Location

Infectious Diseases

Syracuse, Italy

Location

SS. Annunziata

Taranto, Italy

Location

Medicine Unit

Venosa, Italy

Location

Related Publications (4)

• Mangia A, Dalgard O, Minerva N, Verbaan H, Bacca D, Ring-Larsen H, Copetti M, Carretta V, Piazzolla V, Cozzolongo R, Mottola L, Andriulli A. Ribavirin dosage in patients with HCV genotypes 2 and 3 who completed short therapy with peg-interferon alpha-2b and ribavirin. Aliment Pharmacol Ther. 2010 Jun;31(12):1346-53. doi: 10.1111/j.1365-2036.2010.04290.x. Epub 2010 Mar 8.

  PMID: 20222909 BACKGROUND

• Mangia A, Minerva N, Bacca D, Cozzolongo R, Agostinacchio E, Sogari F, Scotto G, Vinelli F, Ricci GL, Romano M, Carretta V, Petruzzellis D, Andriulli A. Determinants of relapse after a short (12 weeks) course of antiviral therapy and re-treatment efficacy of a prolonged course in patients with chronic hepatitis C virus genotype 2 or 3 infection. Hepatology. 2009 Feb;49(2):358-63. doi: 10.1002/hep.22679.

  PMID: 19072829 BACKGROUND

• Andriulli A, Mangia A, Iacobellis A, Ippolito A, Leandro G, Zeuzem S. Meta-analysis: the outcome of anti-viral therapy in HCV genotype 2 and genotype 3 infected patients with chronic hepatitis. Aliment Pharmacol Ther. 2008 Aug 15;28(4):397-404. doi: 10.1111/j.1365-2036.2008.03763.x. Epub 2008 Jun 11.

  PMID: 18549461 BACKGROUND

• Mangia A, Santoro R, Minerva N, Ricci GL, Carretta V, Persico M, Vinelli F, Scotto G, Bacca D, Annese M, Romano M, Zechini F, Sogari F, Spirito F, Andriulli A. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2005 Jun 23;352(25):2609-17. doi: 10.1056/NEJMoa042608.

  PMID: 15972867 BACKGROUND

MeSH Terms

Conditions

Hepatitis, Chronic

Interventions

Ribavirin; peginterferon alfa-2a

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Alessandra Mangia, MD

  IRCCS "Casa Sollievo della Sofferenza"

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: June 27, 2011
• Study Start: December 1, 2018
• Primary Completion: November 30, 2019
• Study Completion: November 30, 2019
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

IT (35)