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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00797706
• Other study ID #: CS-201
• Secondary ID: EudraCT No. 2007
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• First received: November 24, 2008
• Last updated: February 4, 2010
• Start date: November 2008
• Est. completion date: March 2010

Study information

• Verified date: February 2010
• Source: Kringle Pharma Europe AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencySweden: Medical Products Agency
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion criteria (Run-in period):

1. Caucasian male or clinically sterile female subjects

2. 40 years or older.

3. Ankle brachial index of at least 0.6.

4. Written informed consent obtained.

5. Subject legally competent and able to communicate effectively.

6. Subject likely to co-operate.

7. Uncomplicated venous ulcer as by clinical diagnosis.

8. Full skin ulcer.

9. Localisation above the foot and below the knee (wrist and malleoli included)

10. Duration of at least 3 months.

11. Area 3-20 cm2.

Exclusion criteria (Run-in period)

1. Visible signs of infection, black necrosis or discharge in the target ulcer.

2. More than ~20% slough after debridement.

3. Ulcer that by location or extension will either be difficult to follow or to treat according to the protocol.

4. Other known etiology of the target ulcer.

5. Subject having to the discretion of the investigator clinically significant findings on physical examination or vital signs.

6. Concomitant systemic or topical treatment within 14 days prior to start of study medication with antibiotics or antiseptics for treatment of ulcer infection in target ulcer.

7. Concomitant systemic treatment within 14 days prior to start of study medication with immunosuppressives

8. Concomitant topical treatment within 14 days prior to start of study medication with any of the following:

• NSAIDs, aspirin

• Growth factors, or other biologically active agents

• Products containing chlorhexidine, potassium permanganate, iodine or silver

9. Diabetes Mellitus requiring pharmaceutical treatment.

10. Co-morbidity with a life expectancy less than 6 months.

11. Co-morbidity expected to lower compliance.

12. Diagnosed kidney disease

13. Individuals sensitive to any of the study medication components.

14. Subject having received an investigational drug product, or been enrolled in other investigational drug protocols within a period of 30 days prior to receiving the first dose of the study medication.

15. Known abuse of alcohol, drugs or pharmaceuticals.

16. Diagnosis of squamous epithelia carcinoma

17. Diagnoses of a serious psychiatric illness which may influence study participation.

Inclusion criteria (Randomization)

1. Subject likely to co-operate.

2. Ulcer area reduction less than 50% during run-in period.

3. Ulcer area 3-20 cm2.

Exclusion criteria (Randomization)

1.& 2. = Run-in period criteria 1. & 2.

3. Subject having to the discretion of the investigator clinically significant findings on vital signs or laboratory values.

4.-10. = Run-in period criteria 6., 7., 8., 11., 12., 13., & 14

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

Intervention

Drug:
• CHRONSEAL
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions

Locations

Country	Name	City	State
Norway	Medi3 Innlandet AS, Department Elverum	Elverum
Norway	Hudavdelingen Helse	Førde
Norway	Medi 3 Innlandet AS, Department Hamar	Hamar
Norway	Colosseumklinikken	Oslo
Sweden	Vårdcentralen Alvesta	Alvesta
Sweden	Danderyds Sjukhus AB	Danderyd
Sweden	Carema Vårdcentral Gubbängen	Enskede
Sweden	Department of Dermatology and Infectious diseases	Halmstad
Sweden	Husläkarna i Kungsbacka	Kungsbacka
Sweden	Department of Dermatology, Lund University hospital	Lund
Sweden	Department of Dermatology, University Hospital MAS	Malmö
Sweden	Gamla Stans Vårdcentral	Stockholm
Sweden	Taptogatans Husläkare	Stockholm
Sweden	Department of Dermatology, Norrlands University hospital	Umeå
Sweden	Department of Medical Sciences, Section of Dermatology and Venereology, Uppsala University hospital	Uppsala
Sweden	Neptunuskliniken	Varberg

Sponsors (2)

Lead Sponsor	Collaborator
Kringle Pharma Europe AB	Kringle Pharma, Inc.

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To investigate safety and local tolerance of CHRONSEAL® cream containing 2 different concentrations of API, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle.		From start of treatment to 12 weeks post treatment	Yes
Secondary	To investigate the treatment effect on ulcer area reduction and changes of ulcer condition of CHRONSEAL® cream, containing 2 different concentrations API, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle.		From start of treatment to 12 weeks post treatment	No