NCT01621256

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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2013

Longer than P75 for phase_1

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 18, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2018

Completed
Last Updated

December 21, 2018

Status Verified

December 1, 2018

Enrollment Period

5.4 years

First QC Date

June 12, 2012

Last Update Submit

December 20, 2018

Conditions

Hearing LossDeafnessHearing Loss, SensorineuralHearing DisordersEar Diseases

Outcome Measures

Primary Outcomes (1)

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

    From baseline to Day 8

Secondary Outcomes (1)

  • Change in speech recognition in the affected ear

    From baseline to Day 8

Other Outcomes (3)

  • 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

Study Arms (2)

Ancrod

EXPERIMENTAL

Ancrod

Drug: Ancrod

Saline solution

PLACEBO COMPARATOR

Saline solution

Drug: Saline solution

Interventions

AncrodDRUG

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

Also known as: Viprinex, NM-V
Ancrod
Saline solutionDRUG

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

Also known as: Placebo
Saline solution

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Site CZ

Hradec Králové, Czechia

Location

Site CZ

Prague, Czechia

Location

Site D

Göttingen, Germany

Location

Site D

Hamburg, Germany

Location

Site D

Hanover, Germany

Location

Site D

Landsberg am Lech, Germany

Location

Site D

München, Germany

Location

MeSH Terms

Conditions

Hearing LossDeafnessHearing Loss, SensorineuralHearing DisordersEar Diseases

Interventions

AncrodSaline Solution

Condition Hierarchy (Ancestors)

Otorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Venombin ASerine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesCrotalid VenomsViper VenomsSnake VenomsVenomsComplex MixturesToxins, BiologicalBiological FactorsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Martin Canis, MD PhD

    Department for Otorhinolaryngology, LM University Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2012

First Posted

June 18, 2012

Study Start

May 1, 2013

Primary Completion

September 18, 2018

Study Completion

October 30, 2018

Last Updated

December 21, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

CZ(2)DE(5)