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: November 17, 2013
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:
||December 2014 (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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 firstname.lastname@example.org |
Carmel Medical Center
||Eli Zuckerman, M.D.
||Liver Unit, Carmel Medical Center
No publications provided
||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
||November 17, 2013
||Israel: Ethics Commission
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2014
Nervous System Diseases
Signs and Symptoms
Physiological Effects of Drugs