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

This study is currently recruiting participants.
Verified November 2013 by Carmel Medical Center
Information provided by (Responsible Party):
Eli Zuckerman, Carmel Medical Center Identifier:
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.

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 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description


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


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 identifier: NCT01265693

Contact: Eli Zuckerman, M.D. 97248250052
Contact: Orly Azulay, RN 97248250052

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         
Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Eli Zuckerman, M.D.    97248250053 ext 3053   
Sponsors and Collaborators
Carmel Medical Center
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 Identifier: NCT01265693     History of Changes
Other Study ID Numbers: CMC-10-0076-CTIL
Study First Received: December 1, 2010
Last Updated: November 17, 2013
Health Authority: Israel: Ethics Commission

Additional relevant MeSH terms:
Hearing Loss
Hearing Loss, Sudden
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Interferon Alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on April 17, 2014