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

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

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Key information

Conditions

Chronic Hepatitis Chronic Disease Digestive System Diseases Disease Attributes Hepatitis Hepatitis, Chronic Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Ospedale Civile, Sassari, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peg Interferon alpha2b + Ribavirin

Drug

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

Other names: variable

Primary outcomes

Sustained virological response (SVR)

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Casa Sollievo della Sofferenza IRCCS

Other

Registry information

Official study 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

Acronym: genotype-3

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: May 12, 2010
Registry last updated: Aug 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed