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OpenTrials
Completed

NCT Number: NCT01621256

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

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

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Key information

Conditions

Hearing Loss Deafness Ear Diseases Hearing Disorders Hearing Loss, Sensorineural Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Site CZ, Hradec Králové, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ancrod

Drug

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

Other names: Viprinex, NM-V

Saline Solution

Drug

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

Other names: Placebo

Primary outcomes

  1. Change in PTA (pure tone audiogram) in the affected ear

    Time frame: From baseline to Day 8

Secondary outcomes

  1. Change in speech recognition in the affected ear

    Time frame: From baseline to Day 8

Other outcomes

  1. Patient assessment of change in hearing impairment

    Time frame: From baseline to Day 8, Day 30 and Day 90

  2. Change in fibrinogen concentration

    Time frame: From baseline to Day 2 and Day 8

  3. Change in biomarkers

    Time frame: From baseline to Day 8

Sponsors and collaborators

Lead sponsor

Nordmark Arzneimittel GmbH & Co. KG

Industry

Collaborators

  • ClinSupport GmbH
  • LCR Leading Clinical Research s.r.o.
  • MWI Medizinisches Wirtschaftsinstitut GmbH
  • ProjectPharm s.r.o.
  • X-act Cologne Clinical Research GmbH

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 18, 2012
Registry last updated
Dec 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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