Clinical Trial: The Effect of Antiviral Therapy With Pegylated Interferon-alpha on Auditory Disability
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: The Effect of Antiviral Therapy With Pegylated Interferon-alpha for Chronic Hepatitis C and B on Auditory Disability: A Prospective Study
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.
Detailed Summary:
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 pegylated interferon alpha for hepatitis C virus (HCV) and hepatitisB virus (HBV).
Secondary end-point: to investigate the outcome of auditory disability induced by pegylated interferon alpha for HCV and HBV.
Type/design of trial to be conducted: Prospective, longitudinal and controlled trial.
In each participant, base line conventional auditory assessment will be performed as well as during and at the end of treatment. The results will be compared to base-line measurements.
At base line (pre treatment), all participants will undergo a thorough conventional audiological assessment including clinical assessment by an ear, nose and throat (E.N.T) specialist and pure-tone audiometry (air conduction and if necessary also bone conduction), speech reception threshold and discrimination. In case of conductive defect detection, tympanometry will be added to auditory assessment.
Pure-tone audiometry will be re-performed at week 12 of anti-viral treatment and at the end of therapy: at week 24 in genotype 2/3 patients or at week 48 or 72 in genotype 1 patients. Additional unscheduled audiometry tests will be performed at any time during the study if a participant will complain of hearing loss or tinnitus, or as follow-up assessment in patients with treatment-induced hearing loss (as scheduled by the E.N.T specialist (co-investigator).
The following audiometric parameters will be collected:
Current Primary Outcome: to assess the rate of auditory disability induced by pegylated interferon alpha for HCV and HBV. [ Time Frame: Two years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: to investigate the outcome of auditory disability induced by pegylated interferon alpha for HCV and HBV. [ Time Frame: Two years ]
Original Secondary Outcome: Same as current
Information By: Carmel Medical Center
Dates:
Date Received: December 1, 2010
Date Started: January 2011
Date Completion:
Last Updated: July 20, 2016
Last Verified: July 2016
