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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00148863 |
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Date of registration:
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07/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Interferon Gamma With Peg-Interferon Alpha 2a and Ribavirin in Non Responders Patients With Chronic Hepatitis C
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Scientific title:
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Pilot Study on Interferon Gamma in Association With Peg-Interferon Alpha 2a and Ribavirin Among Patients With a Chronic Hepatitis C and Non Responders to the Association of Peg-Interferon Alpha 2b or 2a and Ribavirin ANRS HC16 Gammatri |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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65 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00148863 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Patrice Couzigou, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hôpital du Haut-Lévêque, Pessac, France |
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Name:
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Geneviève Chêne, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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INSERM U593, Bordeaux, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Positive anti-HCV antibodies
- Positive HCV RNA (quantitative method)
- Previous treatment with Peg-interferon alpha 2b 1.0 to 1.5 micro g/kg (during at
least 12 weeks) with ribavirin (at least 800 mg/day during at least 12 weeks),stopped
since at least 3 months
- Without lower dosage during previous treatment
- Non responder to the previous treatment with Peg-interferon alpha 2b and ribavirin,
with detectable HCV RNA at W24 or decrease of less than 2 log10 copies/ml at W12 or
decrease greater than 2 log10 but detectable HCV RNA
- Metavir over F2 on the most recent biopsy
- ALT increase over normal value twice during last 6 months
Exclusion Criteria:
- HIV infection
- Psychiatric pathology
- Alcool consummation
- Cirrhosis
- Pregnancy or plan of pregnancy
- Breastfeeding
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hepatitis C, Chronic
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Intervention(s)
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Drug: Interferon gamma (drug)
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Drug: Ribavirin (drug)
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Drug: Peg-interferon alpha 2a (drug)
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Primary Outcome(s)
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Virological response as defined by an HCV RNA measure non detectable at W28 with qualitative PCR (centralized measure)
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Secondary Outcome(s)
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Biochemical response at W72 (ALT below normal value)
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Quality of life
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Virological response at W72
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Immunologic response (CD4 and CD8 HCV specific)
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Safety
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Secondary ID(s)
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ANRS HC16 Gammatri
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2004-005033-19
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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