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

Sponsor

Nordmark Arzneimittel GmbH & Co. KG (Industry)

Overall Status

Completed

CT.gov ID

NCT01621256

Collaborator

ClinSupport GmbH (Industry), MWI Medizinisches Wirtschaftsinstitut GmbH (Other), ProjectPharm s.r.o. (Other), LCR Leading Clinical Research s.r.o. (Other), X-act Cologne Clinical Research GmbH (Industry)

Enrollment

Locations

Arms

Duration (Months)

4.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss Deafness Hearing Loss, Sensorineural Hearing Disorders Ear Diseases	Drug: Ancrod Drug: Saline solution	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2013

Actual Primary Completion Date :

Sep 18, 2018

Actual Study Completion Date :

Oct 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ancrod Ancrod	Drug: Ancrod Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections Other Names: Viprinex NM-V
Placebo Comparator: Saline solution Saline solution	Drug: Saline solution Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections Other Names: Placebo

Arm

Intervention/Treatment

Experimental: Ancrod

Ancrod

Drug: Ancrod

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

Other Names:

Viprinex

NM-V

Placebo Comparator: Saline solution

Saline solution

Drug: Saline solution

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

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

Change in PTA (pure tone audiogram) in the affected ear [From baseline to Day 8]

Secondary Outcome Measures

Change in speech recognition in the affected ear [From baseline to Day 8]

Other Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	Site CZ	Hradec Králové	Czechia
2	Site CZ	Praha	Czechia
3	Site D	Göttingen	Germany
4	Site D	Hamburg	Germany
5	Site D	Hannover	Germany
6	Site D	Landsberg am Lech	Germany
7	Site D	München	Germany