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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)

Primary Purpose

Chronic Hepatitis

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Peg Interferon alpha2b + Ribavirin
Sponsored by
Casa Sollievo della Sofferenza IRCCS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis focused on measuring genotype 3, Combination treatment, Short treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ospedale Civile
  • Ospedale Casarano
  • IRCCS "De Bellis"
  • Ospedale "Garibaldi"
  • Ospedale "S.Camillo"
  • Università Cattolica Sacro Cuore Roma
  • Ospedale Civile
  • Ospedale Venosa

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

A1. standard duration

B 1 I or II

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2010
Last Updated
August 9, 2011
Sponsor
Casa Sollievo della Sofferenza IRCCS
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1. Study Identification

Unique Protocol Identification Number
NCT01121705
Brief Title
Efficacy Study of New Therapeutic Schedules in Naive Hepatitis C Virus (HCV) Patients Infected With Genotype 3 (HCV-3)
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Casa Sollievo della Sofferenza IRCCS

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis
Keywords
genotype 3, Combination treatment, Short treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
360 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1. standard duration
Arm Type
No Intervention
Arm Description
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.
Arm Title
B 1 I or II
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Peg Interferon alpha2b + Ribavirin
Other Intervention Name(s)
variable
Intervention Description
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
Primary Outcome Measure Information:
Title
Sustained virological response (SVR)
Description
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.
Time Frame
6 months after the end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandra Mangia, MD
Organizational Affiliation
IRCCS - San Giovanni Rotondo
Official's Role
Study Director
Facility Information:
Facility Name
Ospedale Civile
City
Canossa
Country
Italy
Facility Name
Ospedale Casarano
City
Casarano
Country
Italy
Facility Name
IRCCS "De Bellis"
City
Castellana Grotte
Country
Italy
Facility Name
Ospedale "Garibaldi"
City
Catania
Country
Italy
Facility Name
Ospedale "S.Camillo"
City
Rome
Country
Italy
Facility Name
Università Cattolica Sacro Cuore Roma
City
Rome
Country
Italy
Facility Name
Ospedale Civile
City
Sassari
Country
Italy
Facility Name
Ospedale Venosa
City
Venosa
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
18549461
Citation
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.
Results Reference
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Learn more about this trial

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

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