NCT01380938

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,150 (actual)
• Sponsor: Casa Sollievo della Sofferenza IRCCS · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Chronic Hepatitis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2018-12-01
• Primary completion: 2019-11-30
• Completion: 2019-11-30
• First posted: 2011-06-27
• Last updated: 2022-03-24

Locations

35 sites across 1 country: Italy