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Hearing Loss - Healing Genes
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Hearing Loss

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Safety, Tolerability and Efficacy for CGF166 in Patients With Unilateral or Bilateral Severe-to-profound Hearing Loss

A Three-part, Multicenter, Open Label, Single Dose Study to Assess the Safety, Tolerability, and Efficacy of Intra Labyrinthine (IL) CGF166 in Patients With Severe-to-profound Hearing Loss


Phase 1/2

DESCRIPTION:
Doctors at Novartis study centers in KA and OR seek patients with unilateral or bilateral severe-to-profound hearing loss to trial an investigational gene therapy, called CGF166, that uses a viral shell to deliver a gene that can prompt growth of inner-ear hair filaments and possibly improve hearing. The study would require a single intra-labyrinthine (inner-ear) infusion of the drug, then 24 months of follow up to track any negative reactions and hearing improvements.


PATIENT MUST:

  • Up to 18 to 75 years of age
  • Have 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:
    • PTA within 10 dB of the PTA obtained at least 11 months previously
    • Word recognition within 20% of previous test at least 11 months previously
  • Meet residual hearing criteria and vestibular function in the ear that will be studied

THE STUDY INVOLVES:

  1. Prescreening to confirm eligibility of the patient to participate.
  2. Single intra-labyrinthine (inner-ear) infusion of the drug to a single “study ear”.
  3. Follow up will continue for up to 2 years.

LOCATIONS AND CONTACTS:
The study sites are in Kansas City, KA, and Portland, OR. To learn where, contact the trial coordinator below.

CONTACTS:
Novartis Pharmaceuticals  |  1-888-669-6682  |  [email protected]
 
SPONSOR INFORMATION:
Novartis Pharmaceuticals
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT02132130

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