Efficacy Study of New Therapeutic Schedules in Naive Hepatitis C Virus (HCV) Patients Infected With Genotype 3 (HCV-3)

Phase 3

Completed

• Conditions: Chronic Hepatitis
• Interventions: Drug: Peg Interferon alpha2b + Ribavirin

• Registration Number: NCT01121705
• Lead Sponsor: Casa Sollievo della Sofferenza IRCCS

Brief Summary

The study aimed at evaluating whether current 24 weeks length of combination treatment is appropriate or not for patients with HCV genotype 3 infection.

Detailed Description

Patients are randomized to standard length of treatment or to a variable duration: 12 weeks for patients with undetectable HCVRNA at week 4 or 24 or 36 weeks for those with detectable HCV RNA at week 4.

Study Timeline

• Study Start: 2007-01
• Status Verified: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-12
• Last Update Submitted: 2011-08-09
• Last Update Posted: 2011-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Naive HCV patients
• HCVRNA positive
• Normal TSH
• ANA <1:160

Exclusion Criteria

• Portal hypertension
• Renal failure
• HBsAg or HIV
• Alcohol consumption >30 g/day
• Active IV drug use
• Chronic systemic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B 1 I or II	Peg Interferon alpha2b + Ribavirin	In the variable treatment group, patients with a virologic response at week 4 will receive treatment for 12 weeks and those without a virologic response at 4 weeks treatment for 36 weeks. Patients without RVR will be treated for 24 or 36 weeks and labelled (B1I) or (B1II, respectively Intervention: different durations of treatment for patients without RVR

Primary Outcome Measures

Name	Time	Method
Sustained virological response (SVR)	6 months after the end of treatment	The primary measure of efficacy will be HCV RNA not detectable in the serum 24 weeks after the end of therapy (SVR). In addition, virological response at the end of treatment and relapse rates will be calculated for each groups. Two analyses will be performed: 1) intention-to-treat analysis; 2) per-protocol analysis.

Trial Locations

Locations (7)

Ospedale Civile; 🇮🇹 Sassari, Italy

Ospedale Casarano; 🇮🇹 Casarano, Italy

Ospedale "Garibaldi"; 🇮🇹 Catania, Italy

Ospedale Venosa; 🇮🇹 Venosa, Italy

IRCCS "De Bellis"; 🇮🇹 Castellana Grotte, Italy

Ospedale "S.Camillo"; 🇮🇹 Rome, Italy

Università Cattolica Sacro Cuore Roma; 🇮🇹 Rome, Italy