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

Primary Purpose

Hearing Loss, Deafness, Hearing Loss, Sensorineural

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Ancrod
Saline solution
Sponsored by
Nordmark Arzneimittel GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hearing Loss

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Site CZ
  • Site CZ
  • Site D
  • Site D
  • Site D
  • Site D
  • Site D

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ancrod

Saline solution

Arm Description

Ancrod

Saline solution

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in speech recognition in the affected ear

Full Information

First Posted
June 12, 2012
Last Updated
December 20, 2018
Sponsor
Nordmark Arzneimittel GmbH & Co. KG
Collaborators
ClinSupport GmbH, MWI Medizinisches Wirtschaftsinstitut GmbH, ProjectPharm s.r.o., LCR Leading Clinical Research s.r.o., X-act Cologne Clinical Research GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01621256
Brief Title
Efficacy, Safety, and Tolerability of Ancrod in Patients With Sudden Hearing Loss
Official Title
Double-blind, Randomized, Placebo-controlled Study on Efficacy, Safety and Tolerability of Ancrod in Patients With Sudden Sensorineural Hearing Loss (SSHL)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
September 18, 2018 (Actual)
Study Completion Date
October 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordmark Arzneimittel GmbH & Co. KG
Collaborators
ClinSupport GmbH, MWI Medizinisches Wirtschaftsinstitut GmbH, ProjectPharm s.r.o., LCR Leading Clinical Research s.r.o., X-act Cologne Clinical Research GmbH

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Deafness, Hearing Loss, Sensorineural, Hearing Disorders, Ear Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ancrod
Arm Type
Experimental
Arm Description
Ancrod
Arm Title
Saline solution
Arm Type
Placebo Comparator
Arm Description
Saline solution
Intervention Type
Drug
Intervention Name(s)
Ancrod
Other Intervention Name(s)
Viprinex, NM-V
Intervention Description
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Intervention Type
Drug
Intervention Name(s)
Saline solution
Other Intervention Name(s)
Placebo
Intervention Description
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Primary Outcome Measure Information:
Title
Change in PTA (pure tone audiogram) in the affected ear
Time Frame
From baseline to Day 8
Secondary Outcome Measure Information:
Title
Change in speech recognition in the affected ear
Time Frame
From baseline to Day 8
Other Pre-specified Outcome Measures:
Title
Patient assessment of change in hearing impairment
Time Frame
From baseline to Day 8, Day 30 and Day 90
Title
Change in fibrinogen concentration
Time Frame
From baseline to Day 2 and Day 8
Title
Change in biomarkers
Time Frame
From baseline to Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Canis, MD PhD
Organizational Affiliation
Department for Otorhinolaryngology, LM University Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Site CZ
City
Hradec Králové
Country
Czechia
Facility Name
Site CZ
City
Praha
Country
Czechia
Facility Name
Site D
City
Göttingen
Country
Germany
Facility Name
Site D
City
Hamburg
Country
Germany
Facility Name
Site D
City
Hannover
Country
Germany
Facility Name
Site D
City
Landsberg am Lech
Country
Germany
Facility Name
Site D
City
München
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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