drugset / Trial / NCT01380938
Different Ribavirin Dosages and Different Duration of Treatment in Combination With PegInterferon in Patients With Genotype 2 and 3 (WRITE)
Phase 3
Completed
1150 enrolled
Casa Sollievo della Sofferenza IRCCS
Azienda Ospedaliera V. Cervello · collabAzienda Ospedaliera, Lucca · collabAzienda Ospedaliera, Siracusa · collabAzienda Ospedaliero Universitaria di Sassari · collabAzienda Ospedaliero-Universitaria Careggi · collabAzienda Ospedaliero-Universitaria, Catania · collabCampus Bio-Medico University · collabCardarelli Hospital · collabCasa di Cura Mater Dei · collabFondazione IRCCS Policlinico San Matteo di Pavia · collabIRCCS De Bellis, Castellana · collabIRCCS L. Spallanzani · collabOspedale Civile Spirito Santo · collabOspedale Civile Vittorio Emanuele II, Bisceglie · collabOspedale Francesco Ferrari · collabOspedale Monsignor R. Dimiccoli, Barletta · collabOspedale SS. Annunziata, Taranto · collabOspedale San Giuseppe Moscati, Avellino · collabOspedale Sandro Pertini, Roma · collabOspedale Santa Caterina Novella, Galatina · collabOspedale di Canosa di Puglia · collabOspedale di Mottola · collabOspedale di Venosa · collabOspedali Riuniti di Foggia · collabS. Anna Hospital · collabSan Camillo Hospital, Rome · collabUSL Napoli 1 · collabUniversity of Bari · collabUniversity of Florence · collabUniversity of Palermo · collabValduce Hospital · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2018-12-01
- Primary completion
- 2019-11-30
- Completion
- 2019-11-30
Publications
- Background 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Peginterferon alfa-2a | Protein / enzyme biologic | 180 ug | — |
| Subject | Ribavirin | Small molecule | 800 mg | Oral |
| Subject | Ribavirin | Small molecule | 1000 mg | Oral |
| Subject | Ribavirin | Small molecule | 1200 mg | Oral |