- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01121705
Efficacy Study of New Therapeutic Schedules in Naive Hepatitis C Virus (HCV) Patients Infected With Genotype 3 (HCV-3) (genotype-3)
August 9, 2011 updated by: Casa Sollievo della Sofferenza IRCCS
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
The study aimed at evaluating whether current 24 weeks length of combination treatment is appropriate or not for patients with HCV genotype 3 infection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
360
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Canossa, Italy
- Ospedale Civile
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Casarano, Italy
- Ospedale Casarano
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Castellana Grotte, Italy
- IRCCS "De Bellis"
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Catania, Italy
- Ospedale "Garibaldi"
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Rome, Italy
- Ospedale "S.Camillo"
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Rome, Italy
- Università Cattolica Sacro Cuore Roma
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Sassari, Italy
- Ospedale Civile
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Venosa, Italy
- Ospedale Venosa
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
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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
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sustained virological response (SVR)
Time Frame: 6 months after the end of treatment
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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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6 months after the end of treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Alessandra Mangia, MD, IRCCS - San Giovanni Rotondo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
May 4, 2010
First Submitted That Met QC Criteria
May 10, 2010
First Posted (Estimate)
May 12, 2010
Study Record Updates
Last Update Posted (Estimate)
August 10, 2011
Last Update Submitted That Met QC Criteria
August 9, 2011
Last Verified
June 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Ribavirin
- Interferon alpha-2
- Peginterferon alfa-2b
Other Study ID Numbers
- 2007-00437470
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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