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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01121705
Other study ID # 2007-00437470
Secondary ID
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


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
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