Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers

Chronic Venous Leg Ulcers Clinical Trial

Official title: 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 Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Venous Leg Ulcers
• Leg Ulcer
• Ulcer
• Varicose Ulcer

• NCT number: NCT00797706
• Study type: Interventional
• Source: Kringle Pharma Europe AB
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: November 2008
• Completion date: March 2010