Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000066-37 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ClinSupport GmbH | INDUSTRY |
| MWI Medizinisches Wirtschaftsinstitut GmbH | UNKNOWN |
| ProjectPharm s.r.o. | UNKNOWN |
| LCR Leading Clinical Research s.r.o. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ancrod | Experimental | Ancrod |
|
| Saline solution | Placebo Comparator | Saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ancrod | Drug | Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in PTA (pure tone audiogram) in the affected ear | From baseline to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in speech recognition in the affected ear | From baseline to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Martin Canis, MD PhD | Department for Otorhinolaryngology, LM University Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site CZ | Hradec Králové | Czechia | ||||
| Site CZ |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| UNKNOWN |
| X-act Cologne Clinical Research GmbH | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
| Saline solution | Drug | Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections |
|
|
| From baseline to Day 8 |
| Prague |
| Czechia |
| Site D | Göttingen | Germany |
| Site D | Hamburg | Germany |
| Site D | Hanover | Germany |
| Site D | Landsberg am Lech | Germany |
| Site D | München | Germany |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| D003638 | Deafness |
| D006319 | Hearing Loss, Sensorineural |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| ID | Term |
|---|---|
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000721 | Ancrod |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D020791 | Venombin A |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D003435 | Crotalid Venoms |
| D014757 | Viper Venoms |
| D012910 | Snake Venoms |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided