The Effect of Antiviral Therapy With Pegylated Interferon-alpha on Auditory Disability (HLIPT2010)
Verified November 2013 by Carmel Medical Center
Information provided by (Responsible Party):
Eli Zuckerman, Carmel Medical Center
First received: December 1, 2010
Last updated: February 5, 2015
Last verified: November 2013
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 auditory disability caused by interferon alpha.
||Observational Model: Cohort
Time Perspective: Prospective
||The Effect of Antiviral Therapy With Pegylated Interferon-alpha for Chronic Hepatitis C and B on Auditory Disability: A Prospective Study
Primary Outcome Measures:
- to assess the rate of auditory disability induced by pegylated interferon alpha for HCV and HBV. [ Time Frame: Two years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- to investigate the outcome of auditory disability induced by pegylated interferon alpha for HCV and HBV. [ Time Frame: Two years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 80 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Patients with chronic hepatitis C or B treated with pegylated interferon alpha
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01265693
|Carmel Medical Center
|Haifa, Israel, 34262 |
|Principal Investigator: Eli Zuckerman, M.D. (Prof.) |
|Sub-Investigator: Yulia Kovalev, MD |
|Sub-Investigator: Rawie Hazan, MD |
|Carmel Medical Center
|Haifa, Israel, 34362 |
|Contact: Eli Zuckerman, M.D. 97248250053 ext 3053 email@example.com |
Carmel Medical Center
||Eli Zuckerman, M.D.
||Liver Unit, Carmel Medical Center
No publications provided
ClinicalTrials.gov processed this record on February 27, 2015
||Eli Zuckerman, Director of Liver Unit Carmel Medical Center, Carmel Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 1, 2010
||February 5, 2015
||Israel: Ethics Commission