Clinical trial NCT00797706: Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Venous Leg Ulcers
Lead sponsor: Kringle Pharma Europe AB
Sponsor class: INDUSTRY
Collaborators: name: Kringle Pharma, Inc.
First posted: 2008-11-25
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: From start of treatment to 12 weeks post treatment
Secondary outcomes:
measure: 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.
timeFrame: From start of treatment to 12 weeks post treatment
Other outcomes:
Locations:
city: Elverum
country: Norway
facility: Medi3 Innlandet AS, Department Elverum
city: Førde
country: Norway
facility: Hudavdelingen Helse
city: Hamar
country: Norway
facility: Medi 3 Innlandet AS, Department Hamar
city: Oslo
country: Norway
facility: Colosseumklinikken
city: Alvesta
country: Sweden
facility: Vårdcentralen Alvesta
city: Danderyd
country: Sweden
facility: Danderyds Sjukhus AB
city: Enskede
country: Sweden
facility: Carema Vårdcentral Gubbängen
city: Halmstad
country: Sweden
facility: Department of Dermatology and Infectious diseases
city: Kungsbacka
country: Sweden
facility: Husläkarna i Kungsbacka
city: Lund
country: Sweden
facility: Department of Dermatology, Lund University hospital
city: Malmö
country: Sweden
facility: Department of Dermatology, University Hospital MAS
city: Stockholm
country: Sweden
facility: Gamla Stans Vårdcentral
city: Stockholm
country: Sweden
facility: Taptogatans Husläkare
city: Umeå
country: Sweden
facility: Department of Dermatology, Norrlands University hospital
city: Uppsala
country: Sweden
facility: Department of Medical Sciences, Section of Dermatology and Venereology, Uppsala University hospital
city: Varberg
country: Sweden
facility: Neptunuskliniken
Study officials:
affiliation: Medi 3 Innlandet AS, avd Hamar
name: Hans Olav Høivik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Halland County Council, Department of Dermatology and Infectious diseases, Halmstad, Sweden
name: Karin Andersson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Endocrinology, University Hospital Malmö,
name: Jan Apelqvist, Assoc. Prof., PhD, MD
role: STUDY_CHAIR
References: