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?Idiopathic sudden sensorineural hearing loss treatment by Infliximab injection (TNF-alfa blocker)? - ND

?Idiopathic sudden sensorineural hearing loss treatment by Infliximab injection (TNF-alfa blocker)? - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-004074-10-IT
Enrollment
Unknown
Registered
2008-01-04
Start date
2007-11-27
Completion date
Unknown
Last updated
2014-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic sudden hearing loss MedDRA version: 9.1 Level: HLT Classification code 10027666 Term: Ear disorders NEC

Interventions

Trade Name: REMICADE Pharmaceutical Form: Solution for injection INN or Proposed INN: Infliximab Concentration unit: mg milligram(s) Concentration type: equal Concentration number: .3-

Sponsors

POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: idiopathic sudden sensorineural hearing loss (severe or profound pure tone average) no responders to protocol therapy; caucasian race subjects; age range 20-80 years; female and males. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: familiar history of hearing loss; immunodeficiency disease; severe heart and vascular disease; pharmacological intolerance; cases responders to protocol therapy.

Design outcomes

Primary

MeasureTime frame
Main Objective: to evaluate therapeutic effect;Secondary Objective: nd;Primary end point(s): nd—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026