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

Hearing Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621256
• Other study ID #: NM-V-101
• Secondary ID: 2012-000066-37
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 2013
• Est. completion date: October 30, 2018

Study information

• Verified date: December 2018
• Source: Nordmark Arzneimittel GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 30, 2018
• Est. primary completion date: September 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ancrod
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
• Saline solution
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections

Locations

Country	Name	City	State
Czechia	Site CZ	Hradec Králové
Czechia	Site CZ	Praha
Germany	Site D	Göttingen
Germany	Site D	Hamburg
Germany	Site D	Hannover
Germany	Site D	Landsberg am Lech
Germany	Site D	München

Sponsors (6)

Lead Sponsor	Collaborator
Nordmark Arzneimittel GmbH & Co. KG	ClinSupport GmbH, LCR Leading Clinical Research s.r.o., MWI Medizinisches Wirtschaftsinstitut GmbH, ProjectPharm s.r.o., X-act Cologne Clinical Research GmbH

Countries where clinical trial is conducted

Czechia,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient assessment of change in hearing impairment		From baseline to Day 8, Day 30 and Day 90
Other	Change in fibrinogen concentration		From baseline to Day 2 and Day 8
Other	Change in biomarkers		From baseline to Day 8
Primary	Change in PTA (pure tone audiogram) in the affected ear		From baseline to Day 8
Secondary	Change in speech recognition in the affected ear		From baseline to Day 8