A Phase 3 interventional study of Peginterferon alpha-2a + Ribavirin in Chronic Hepatitis, sponsored by Casa Sollievo della Sofferenza IRCCS. Completed at 35 sites in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-03-24.
Sponsored by Casa Sollievo della Sofferenza IRCCS · Phase 3, Interventional, and Treatment
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.
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.
Exclusion Criteria:
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.
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
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
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
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).
Time frame: 6 months after the end of treatment
Rapid virological response (RVR)
proportion of patients with undetectable HCV RNA 4 weeks after the start of treatment
Time frame: On treatment week 4
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Casa Sollievo della Sofferenza IRCCS