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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Chronic Venous Leg Ulcers	Drug: CHRONSEAL	Phase 1; Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	75 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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
Study Start Date :	November 2008
Estimated Primary Completion Date :	March 2010
Estimated Study Completion Date :	March 2010

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Vehicle	Drug: CHRONSEAL; Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
Experimental: Low dose	Drug: CHRONSEAL; Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
Experimental: High dose	Drug: CHRONSEAL; Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions

Outcome Measures

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Primary Outcome Measures :

1. 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. [ Time Frame: From start of treatment to 12 weeks post treatment ]

Secondary Outcome Measures :

1. 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. [ Time Frame: From start of treatment to 12 weeks post treatment ]

Eligibility Criteria

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Ages Eligible for Study:	40 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

Norway
Medi3 Innlandet AS, Department Elverum
Elverum, Norway, 2402
Hudavdelingen Helse
Førde, Norway, 6807
Medi 3 Innlandet AS, Department Hamar
Hamar, Norway, 2317
Colosseumklinikken
Oslo, Norway, 0369
Sweden
Vårdcentralen Alvesta
Alvesta, Sweden, 342 30
Danderyds Sjukhus AB
Danderyd, Sweden, SE-182 88
Carema Vårdcentral Gubbängen
Enskede, Sweden, SE-122 45
Department of Dermatology and Infectious diseases
Halmstad, Sweden, SE-301 85
Husläkarna i Kungsbacka
Kungsbacka, Sweden, SE-434 30
Department of Dermatology, Lund University hospital
Lund, Sweden, SE-221 85
Department of Dermatology, University Hospital MAS
Malmö, Sweden, SE-205 02
Gamla Stans Vårdcentral
Stockholm, Sweden, SE-111 29
Taptogatans Husläkare
Stockholm, Sweden, SE-115 26
Department of Dermatology, Norrlands University hospital
Umeå, Sweden, SE-901 85
Department of Medical Sciences, Section of Dermatology and Venereology, Uppsala University hospital
Uppsala, Sweden, SE-751 05
Neptunuskliniken
Varberg, Sweden, SE-432 44

Sponsors and Collaborators

Kringle Pharma Europe AB

Kringle Pharma, Inc.

Investigators

Principal Investigator:	Hans Olav Høivik, MD	Medi 3 Innlandet AS, avd Hamar
Principal Investigator:	Karin Andersson, MD	Halland County Council, Department of Dermatology and Infectious diseases, Halmstad, Sweden
Study Chair:	Jan Apelqvist, Assoc. Prof., PhD, MD	Department of Endocrinology, University Hospital Malmö,

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Prof. Anders Vahlne/CEO, Kringle Pharma Europe AB
ClinicalTrials.gov Identifier:	NCT00797706 History of Changes
Other Study ID Numbers:	CS-201; EudraCT No. 2007-002695-34
First Posted:	November 25, 2008
Last Update Posted:	February 5, 2010
Last Verified:	February 2010

Additional relevant MeSH terms:

Ulcer; Leg Ulcer; Varicose Ulcer; Pathologic Processes; Skin Ulcer	Skin Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases