A Phase 1/2 interventional study of Ancrod and Saline solution in Hearing Loss, Deafness and Hearing Loss, Sensorineural, sponsored by Nordmark Arzneimittel GmbH & Co. KG. Completed at 7 sites in 2 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-12-21.
Sponsored by Nordmark Arzneimittel GmbH & Co. KG · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine whether ancrod is effective and safe in the treatment of sudden sensorineural hearing loss (SSHL).
796 studies on the registry are indexed under Hearing Loss; 193 are open to participants now.
This study's enrollment of 31 is below the median of 44 across 561 interventional studies indexed under Hearing Loss.
Browse Hearing Loss studies →Nordmark Arzneimittel GmbH & Co. KG is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ancrod
Drug: Ancrod
Saline solution
Drug: Saline solution
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Also known as: Viprinex, NM-V
Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
Also known as: Placebo
Change in PTA (pure tone audiogram) in the affected ear
Time frame: From baseline to Day 8
Change in speech recognition in the affected ear
Time frame: From baseline to Day 8
Patient assessment of change in hearing impairment
Time frame: From baseline to Day 8, Day 30 and Day 90
Change in fibrinogen concentration
Time frame: From baseline to Day 2 and Day 8
Change in biomarkers
Time frame: From baseline to Day 8
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ancrod
Nordmark Arzneimittel GmbH & Co. KG