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

This study has been completed.
Sponsor:
Information provided by:
Casa Sollievo della Sofferenza IRCCS
ClinicalTrials.gov Identifier:
NCT01121705
First received: May 4, 2010
Last updated: August 9, 2011
Last verified: June 2009
  Purpose

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


Condition Intervention Phase
Chronic Hepatitis
Drug: Peg Interferon alpha2b + Ribavirin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Casa Sollievo della Sofferenza IRCCS:

Primary Outcome Measures:
  • Sustained virological response (SVR) [ Time Frame: 6 months after the end of treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 360
Study Start Date: January 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: A1. standard duration
Patients were randomly assigned in a 1:1 ratio to two treatment arms. In the standard treatment group (A1), patients were treated for 24 weeks irrespective of the HCV RNA status at week 4 with Peg-interferon alfa-2b at a dose of 1.5 mcg per kilogram of body weight weekly in combination with oral ribavirin administered at a dose of 1000 mg/day for patients with a weight <75 kg or 1200 mg/day for those with a weight of ≥75 kg. Patients enrolled in Arm A1 will be treated for standard 24 weeks duration of treatment with standard dosages of PegInterferon alpha 2b and weight-based dosages of ribavirin.
Experimental: B 1 I or II
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
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

Other Name: variable

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121705

Locations
Italy
Ospedale Civile
Canossa, Italy
Ospedale Casarano
Casarano, Italy
IRCCS "De Bellis"
Castellana Grotte, Italy
Ospedale "Garibaldi"
Catania, Italy
Università Cattolica Sacro Cuore Roma
Rome, Italy
Ospedale "S.Camillo"
Rome, Italy
Ospedale Civile
Sassari, Italy
Ospedale Venosa
Venosa, Italy
Sponsors and Collaborators
Casa Sollievo della Sofferenza IRCCS
Investigators
Study Director: Alessandra Mangia, MD IRCCS - San Giovanni Rotondo
  More Information

Publications:
Responsible Party: Angelo Andriulli, MD, IRCCS "Casa Sollievo della Sofferenza"
ClinicalTrials.gov Identifier: NCT01121705     History of Changes
Other Study ID Numbers: 2007-00437470
Study First Received: May 4, 2010
Last Updated: August 9, 2011
Health Authority: Italy: Ethics Committee

Keywords provided by Casa Sollievo della Sofferenza IRCCS:
genotype 3
Combination treatment
Short treatment

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Ribavirin
Peginterferon alfa-2b
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 20, 2014