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

Double-blind, Randomized, Placebo-controlled Study on Efficacy, Safety and Tolerability of Ancrod in Patients With Sudden Sensorineural Hearing Loss (SSHL)

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01621256

Enrollment

Registered

2012-06-18

Start date

2013-05-31

Completion date

2018-10-30

Last updated

2018-12-21

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

Conditions

Deafness, Ear Diseases, Hearing Disorders, Hearing Loss, Hearing Loss, Sensorineural

Brief summary

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

Interventions

DRUGAncrod

Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections

DRUGSaline solution

Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in PTA (pure tone audiogram) in the affected ear	From baseline to Day 8

Secondary

Measure	Time frame
Change in speech recognition in the affected ear	From baseline to Day 8

Other

Measure	Time frame
Patient assessment of change in hearing impairment	From baseline to Day 8, Day 30 and Day 90
Change in fibrinogen concentration	From baseline to Day 2 and Day 8
Change in biomarkers	From baseline to Day 8

Countries

Czechia, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026