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

Chronic Hepatitis Clinical Trial

— genotype-3  

Official title:

Multicenter Study on Efficacy of New Therapeutic Schedules With Peg-Interferon alpha2b and Ribavirin in Patients With Genotype 3 Chronic HCV( Hepatitis C Virus) Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01121705
• Other study ID #: 2007-00437470
• Status: Completed
• Phase: Phase 3
• First received: May 4, 2010
• Last updated: August 9, 2011
• Start date: January 2007
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Casa Sollievo della Sofferenza IRCCS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis, Chronic

Intervention

Drug:
• Peg Interferon alpha2b + Ribavirin
B 1 I or II: Experimental variable duration of treatment group according with RVR. In case of RVR present patients will be treated for 12 weeks. Patients without RVR will be treated for 24 (B1I) or 36 (B1II)weeks: different duration of treatment for patients without RVR

Locations

Country	Name	City	State
Italy	Ospedale Civile	Canossa
Italy	Ospedale Casarano	Casarano
Italy	IRCCS "De Bellis"	Castellana Grotte
Italy	Ospedale "Garibaldi"	Catania
Italy	Ospedale "S.Camillo"	Rome
Italy	Università Cattolica Sacro Cuore Roma	Rome
Italy	Ospedale Civile	Sassari
Italy	Ospedale Venosa	Venosa

Sponsors (1)

Lead Sponsor	Collaborator
Casa Sollievo della Sofferenza IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response (SVR)	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.	6 months after the end of treatment	No