Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-25 @ 1:28 AM
NCT ID:
NCT01267994
Eligibility Criteria:
Inclusion Criteria:
* Bilateral sensorineural hearing loss with an active decline in hearing in one ear
* No audiometric improvement with 28-30 days of oral prednisone or other corticosteroid, including an initial dose of 60mg per day for 14 days
* Enrollment within 14 days of completion of corticosteroid therapy
* Age 13 years and older
* No evidence of neutropenia (low white blood cell count)
* No evidence of retrocochlear pathology (ie. acoustic neuroma/vestibular schwannoma)
* May have concurrent, systemic autoimmune disease
Exclusion Criteria:
* Age over 75, or less than 13
* Neutropenia
* Renal insufficiency
* Pregnant females
* Unilateral hearing loss
* Patients with any immunodeficiency syndrome
* Patients receiving methotrexate or any TNF (tumor necrosis factor) antagonist therapy
* Patients with chronic infections
* Patients treated for a malignancy within the past 3 years
* Patients with a latex allergy
* Patients with an inner ear anomaly
* Patients with retrocochlear pathology
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
75 Years
Study:
NCT01267994
Study Brief:
Protocol Section:
NCT01267994