The Effect of Antiviral Therapy With Pegylated Interferon-alpha on Auditory Disability
HLIPT2010
1 other identifier
observational
100
1 country
2
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 auditory disability caused by interferon alpha.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2011
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 23, 2010
CompletedStudy Start
First participant enrolled
January 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2015
CompletedJuly 24, 2018
July 1, 2018
4.1 years
December 1, 2010
July 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
to assess the rate of auditory disability induced by pegylated interferon alpha for HCV and HBV.
Two years
Secondary Outcomes (1)
to investigate the outcome of auditory disability induced by pegylated interferon alpha for HCV and HBV.
Two years
Eligibility Criteria
Patients with chronic hepatitis C or B treated with pegylated interferon alpha
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Carmel Medical Center
Haifa, 34262, Israel
Carmel Medical Center
Haifa, 34362, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eli Zuckerman, M.D.
Liver Unit, Carmel Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Liver Unit Carmel Medical Center
Study Record Dates
First Submitted
December 1, 2010
First Posted
December 23, 2010
Study Start
January 9, 2011
Primary Completion
March 1, 2015
Study Completion
March 26, 2015
Last Updated
July 24, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share