Trials / Unknown
UnknownNCT00797706
Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers
A Phase I/II Double-Blind, Dose Ranging, Vehicle Controlled, Randomized, Parallel Groups, Safety, Tolerability and Efficacy Study of CHRONSEAL® (5-amino-acid Deleted Recombinant Human Hepatocyte Growth Factor (KP-dHGF)), in Subjects With Venous Leg Ulcers
- Status
- Unknown
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- Kringle Pharma Europe AB · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL intended for future treatment of chronic venous leg ulcers is safe and tolerated and if it has an ulcer size reduction effect when administered to individuals suffering from venous leg ulcers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CHRONSEAL | Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions |
Timeline
- Start date
- 2008-11-01
- Primary completion
- 2010-03-01
- Completion
- 2010-03-01
- First posted
- 2008-11-25
- Last updated
- 2010-02-05
Locations
16 sites across 2 countries: Norway, Sweden
Source: ClinicalTrials.gov record NCT00797706. Inclusion in this directory is not an endorsement.