Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss

• Status: Completed
• Trial end date: 2018-10-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nordmark Arzneimittel GmbH & Co. KG
• Collaborators: ClinSupport GmbH; LCR Leading Clinical Research s.r.o.; MWI Medizinisches Wirtschaftsinstitut GmbH; ProjectPharm s.r.o.; X-act Cologne Clinical Research GmbH
• Treatments: Ancrod; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB

• Symmetric hearing prior to onset of SSHL

• Enrollment has to be accomplished within 7 days after SSHL onset

Exclusion Criteria:

• Bilateral SSHL

• Incomplete recovery after previous SSHL

• Previously existing, known retrocochlear hearing loss

• Any history of any ear operation or local inflammatory disease in the past one year

• History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL

• History of Meniere's disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops.

• Treatment with steroids for any reason within the preceding 30 days.

• Body weight > 140 kg