The Effect of Antiviral Therapy With Pegylated Interferon-alpha on Auditory Disability (HLIPT2010)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Zuckerman, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01265693
First received: December 1, 2010
Last updated: July 20, 2016
Last verified: July 2016
  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 ]

Enrollment: 100
Study Start Date: January 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

Locations
Israel
Carmel Medical Center
Haifa, Israel, 34262
Carmel Medical Center
Haifa, Israel, 34362
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Eli Zuckerman, M.D. Liver Unit, Carmel Medical Center
  More Information

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: July 20, 2016
Health Authority: Israel: Ethics Commission
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sudden
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Interferons
Interferon-alpha
Antiviral Agents
Antineoplastic Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 25, 2016