Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-pā¦ (NCT02132130) | Clinical Trial Compass
CompletedPhase 1/2
Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss
United States22 participantsStarted 2014-06-23
Plain-language summary
The goal of the study was to evaluate the safety, tolerability, and the potential ability of CGF166 delivered through IL-infusion to improve hearing. CGF166 is a recombinant adenovirus 5 (Ad5) vector containing a cDNA encoding the human Atonal transcription factor (Hath1).
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Written informed consent must be obtained before any assessment is performed.
ā. For all Parts A, B and C of the study, male or female patients, 18 to 75 years old, inclusive, with severe-to-profound bilateral hearing loss or unilateral hearing loss with intact vestibular function in the nonoperative ear. Non-fluctuating severe-to-profound hearing loss is required for the study ear and is defined as:
ā. Candidate ear ("study ear"): Minimal residual hearing based on the pure tone average of 0.5, 1, 2, and 4 kHz thresholds of ā¤110 dB HL
ā. Candidate ear ("study ear"): Pure tone audiometric thresholds of ā„50 dB HL for each testable octave frequency of 0.125 and 0.250 kHz, ā„70 dB HL for each testable octave frequency from 0.5 through 8 kHz and sentence recognition scores ā¤50% at screening.
Exclusion criteria
ā. Patients with hearing loss caused by genetic/developmental disorders, e.g., cochlea aplasia
ā. Patients with existing conductive hearing loss or mixed hearing loss as judged by the Principal Investigator following a thorough review of all of the trial hearing assessments;
ā. Patients with a history of cochlear implant in the study ear
ā. Hearing loss due to any other cause that would not be expected to respond to hair cell regeneration, for example mechanical trauma or central auditory lesions or lack of an auditory nerve
ā. Patients who will require ototoxic drugs as routine therapy over the course of the study, for example cystic fibrosis patients
What they're measuring
1
Number of Participants With Adverse Events
Timeframe: week 52
2
Number of Adverse Events
Timeframe: week 52
3
Summary of Pure Tone Audiometry in Treated Ear Compared to Pretreatment Values
. Any contraindication to the planned surgery or anesthesia as determined by the surgeon or anesthesiologist
ā. Previous surgery in the study ear
ā. Any otological history, such as chronic otitis, cholesteatoma, tympanic membrane perforation, that suggests poor candidacy for cochlear implant or inner ear surgery or suggests potential interference with study auditory or vestibular function tests