The Effect of Antiviral Therapy With Pegylated Interferon-alpha on Auditory Disability (HLIPT2010)
This study is not yet open for participant recruitment.
Verified December 2010 by Carmel Medical Center
Sponsor:
Carmel Medical Center
Information provided by (Responsible Party):
Eli Zuckerman, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01265693
First received: December 1, 2010
Last updated: March 25, 2012
Last verified: December 2010
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Purpose
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.
| Condition |
|---|
|
Hearing Loss Sudden Deafness |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | The Effect of Antiviral Therapy With Pegylated Interferon-alpha for Chronic Hepatitis C and B on Auditory Disability: A Prospective Study |
Resource links provided by NLM:
Further study details as provided by Carmel Medical Center:
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: | 100 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2013 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with chronic hepatitis C or B treated with pegylated interferon alpha
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265693
Contacts
| Contact: Eli Zuckerman, M.D. | 97248250052 | elizuc@clalit.org.il |
| Contact: Orly Azulay, RN | 97248250052 | orlyaz@clalit.org.il |
Locations
| Israel | |
| Carmel Medical Center | Not yet recruiting |
| Haifa, Israel, 34262 | |
| Principal Investigator: Eli Zuckerman, M.D. (Prof.) | |
| Sub-Investigator: Yulia Kovalev, MD | |
| Sub-Investigator: Rawie Hazan, MD | |
Sponsors and Collaborators
Carmel Medical Center
Investigators
| Principal Investigator: | Eli Zuckerman, M.D. | Liver Unit, Carmel Medical Center |
More Information
No publications provided
| Responsible Party: | Eli Zuckerman, Director of Liver Unit Carmel Medical Center, Carmel Medical Center |
| ClinicalTrials.gov Identifier: | NCT01265693 History of Changes |
| Other Study ID Numbers: | CMC-10-0076-CTIL |
| Study First Received: | December 1, 2010 |
| Last Updated: | March 25, 2012 |
| Health Authority: | Israel: Ethics Commission |
Additional relevant MeSH terms:
|
Deafness Hearing Loss Hearing Loss, Sudden Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms Interferon-alpha Interferon Alfa-2a |
Antiviral Agents Interferons Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013