drugset / Trial / NCT01699347
Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432
NaSingle-groupOpen-labelTreatment
Summary
Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head and neck region. The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood tests. The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up will be of short term - till 30 days post injection and long term - follow-up wil be till 2 years.
Timeline
- Start
- 2012-09
- Primary completion
- 2014-01
- Completion
- 2016-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OK-432 | Unknown | 0.2 mg | Other |
Indications
No indication recorded.