Different Ribavirin Dosages and Different Duration of Treatment in Combination With PegInterferon in Patients With Genotype 2 and 3 (WRITE)
NCT ID: NCT01380938
Last Updated: 2022-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1150 participants
INTERVENTIONAL
2018-12-01
2019-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
No interventions assigned to this group
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)
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)
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)
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)
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Casa di Cura Mater Dei
UNKNOWN
IRCCS L. Spallanzani
UNKNOWN
Ospedale Francesco Ferrari
OTHER
Azienda Ospedaliero Universitaria di Sassari
OTHER
Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Arcispedale S. Anna, Ferrara
UNKNOWN
Azienda Ospedaliero-Universitaria, Catania
UNKNOWN
Ospedale di Venosa
UNKNOWN
Ospedale Monsignor R. Dimiccoli, Barletta
OTHER
IRCCS De Bellis, Castellana
UNKNOWN
USL Napoli 1
UNKNOWN
Ospedale San Giuseppe Moscati, Avellino
UNKNOWN
Cardarelli Hospital
OTHER
Ospedale Civile Vittorio Emanuele II, Bisceglie
UNKNOWN
Azienda Ospedaliero-Universitaria Careggi
OTHER
Azienda Ospedaliera V. Cervello
OTHER
Ospedale Civile Spirito Santo
OTHER
Ospedale di Canosa di Puglia
UNKNOWN
University of Palermo
OTHER
San Camillo Hospital, Rome
OTHER
Campus Bio-Medico University
OTHER
Ospedale Sandro Pertini, Roma
OTHER
Ospedali Riuniti di Foggia
OTHER
Ospedale SS. Annunziata, Taranto
UNKNOWN
Ospedale di Mottola
UNKNOWN
Ospedale Santa Caterina Novella, Galatina
UNKNOWN
University of Florence
OTHER
Ospedale Valduce, Como
UNKNOWN
University of Bari
OTHER
Azienda Ospedaliera, Siracusa
UNKNOWN
Azienda Ospedaliera, Lucca
UNKNOWN
Casa Sollievo della Sofferenza IRCCS
OTHER
Responsible Party
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Alessandra Mangia
MD
Principal Investigators
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Alessandra Mangia, MD
Role: STUDY_DIRECTOR
IRCCS "Casa Sollievo della Sofferenza"
Locations
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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 Grotte, , Italy
Hepatology Unit
Catania, , Italy
Infectious Diseases Unit
Catania, , Italy
Gastroenterology Unit
Como, , Italy
Gastroenterology Unit Arcispedale "S. Anna"
Ferrara, , Italy
Gastroenterology Unit
Florence, , Italy
Internal Medicine University of Firenze
Florence, , 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
Infectious Diseases Unit Ospedale Civile
Sassari, , Italy
Medicine Unit
Sassari, , Italy
Infectious Diseases
Syracuse, , Italy
SS. Annunziata
Taranto, , Italy
Medicine Unit
Venosa, , Italy
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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EPAT-01-2010
Identifier Type: -
Identifier Source: org_study_id
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