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

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ClinicalTrials.gov Identifier: NCT01121705
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : August 10, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis Drug: Peg Interferon alpha2b + Ribavirin Phase 3

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : January 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121705


Locations
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, Italy
Sponsors and Collaborators
Casa Sollievo della Sofferenza IRCCS
Investigators
Study Director: Alessandra Mangia, MD IRCCS - San Giovanni Rotondo

Publications:
Responsible Party: Angelo Andriulli, MD, IRCCS "Casa Sollievo della Sofferenza"
ClinicalTrials.gov Identifier: NCT01121705     History of Changes
Other Study ID Numbers: 2007-00437470
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: August 10, 2011
Last Verified: June 2009

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs