Status:
COMPLETED
The Effect of Antiviral Therapy With Pegylated Interferon-alpha on Auditory Disability
Lead Sponsor:
Carmel Medical Center
Conditions:
Hearing Loss
Sudden Deafness
Eligibility:
All Genders
18-80 years
Brief Summary
The aim of the study is to assess the effect of antiviral therapy with pegylated interferon alpha for hepatitis C and B on auditory disability as there are reports in the English literature on auditor...
Detailed Description
The population to be studied: Patients with chronic hepatitis C or B treated by pegylated interferon- alpha. Trial Design Primary end-point: to assess the rate of auditory disability induced by pegyl...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients with chronic hepatitis C virus infection who will receive anti viral treatment consists of PEG-IFN-alpha-2a or 2b combined with ribavirin,
- Patients with chronic hepatitis B who receive anti-viral treatment with PEG-IFN-alpha 2a (Pegasys)
- Age 18-70 who are eligible for anti viral treatment.
- Patients who attend and are treated in the Liver Unit of Haifa and Western
- Galilee District of Clalit Health Services and Carmel Medical Center will be recruited.
- Patients with all HCV genotypes will be included and will be treated by the standard-of-care therapy for hepatitis C: 48 weeks for genotypes 1 or 4.
- Patients and 24 weeks for genotypes 2 or 3.
- Virological response will be determined at week 12 of treatment. In non-responders therapy will be discontinued.
- In those patients with genotype 1 and "'slow virological response", 72 weeks of therapy will be considered. Included will be also patients with chronic hepatitis B receiving PEG-IFN alpha 2a for up to 48 weeks.
Exclusion
Key Trial Info
Start Date :
January 9 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 26 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01265693
Start Date
January 9 2011
End Date
March 26 2015
Last Update
July 24 2018
Active Locations (2)
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1
Carmel Medical Center
Haifa, Israel, 34262
2
Carmel Medical Center
Haifa, Israel, 34362