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Phase IIa Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers
This study is currently recruiting participants.
Verified by Tripep AB, December 2008
First Received: November 24, 2008   Last Updated: December 21, 2008   History of Changes
Sponsors and Collaborators: Tripep AB
Kringle Pharma, Inc.
Information provided by: Tripep AB
ClinicalTrials.gov Identifier: NCT00797706
  Purpose

The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL intended for future treatment of chronic venous leg ulcers has an ulcer size reduction effect and if it is safe and tolerated when administered to individuals suffering from venous leg ulcers.


Condition Intervention Phase
Chronic Venous Leg Ulcers
Drug: CHRONSEAL
Phase II

MedlinePlus related topics: Leg Injuries and Disorders
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title: Efficacy and Safety of CHRONSEAL® (5-Amino-Acid Deleted Recombinant Human Hepatocyte Growth Factor (KP-dHGF)), in Subjects With Venous Leg Ulcers. A Double-Blind, Vehicle Controlled, Parallel Groups, Randomized, Dose Range, Proof of Concept Study.

Further study details as provided by Tripep AB:

Primary Outcome Measures:
  • To investigate the treatment effect on ulcer area reduction of CHRONSEAL® cream, containing 3 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To investigate the effects of CHRONSEAL® cream on the changes in ulcer condition [ Time Frame: From start of treatment to 12 weeks post treatment ] [ Designated as safety issue: Yes ]
  • To investigate the effects of CHRONSEAL® cream on the safety and local tolerance [ Time Frame: From start of treatment to 12 weeks post treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: November 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Vehicle: Placebo Comparator Drug: CHRONSEAL
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
Low dose: Experimental Drug: CHRONSEAL
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
High dose: Experimental Drug: CHRONSEAL
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria (Run-in period):

  1. Caucasian male or clinically sterile female subjects
  2. 40-85 years of age.
  3. Ankle brachial index of at least 0.8.
  4. Written informed consent obtained.
  5. Subject legally competent and able to communicate effectively.
  6. Subject likely to co-operate and attend the clinic.
  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 any of the following:

    • Corticosteroids or immunosuppressives

    • Continuous treatment with NSAIDs or aspirin (aspirin above 75 mg)

  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 and attend the clinic at the appointed times during the rest of the study.
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00797706

Locations
Norway
Medi 3 Innlandet AS, Department Hamar Recruiting
Hamar, Norway, 2317
Contact: Hans Olav Høivik, MD     +47 62 52 05 60     hans.olav.hoivik@medi3-innlandet.nhn.no    
Principal Investigator: Hans Olav Høivik, MD            
Colosseumklinikken Recruiting
Oslo, Norway, 0369
Contact: Dagfinn Aarskog, MD     +47 23 19 60 40     aarskog@colosseumlegene.no    
Principal Investigator: Dagfinn Aarskog, MD            
Medi3 Innlandet AS, Department Elverum Recruiting
Elverum, Norway, 2402
Contact: Sigbjørn Elle, MD     +47 62 42 84 00     sigbjorn.elle@medi3-innlandet.nhn.no    
Principal Investigator: Sigbjørn Elle, MD            
Hudavdelingen Helse, Førde Recruiting
Førde, Norway, 6807
Contact: Øystein Vatne, MD     +47 57 83 93 66     oystein.vatne@helse-forde.no    
Principal Investigator: Øystein Vatne, MD            
Sweden
Department of Dermatology, Norrlands University hospital Not yet recruiting
Umeå, Sweden, 901 85
Contact: Anette Laestadius, MD     +46 90 785 20 38     Anette.Laestadius@vll.se    
Principal Investigator: Anette Laestadius, MD            
Department of Dermatology, Lund University hospital Not yet recruiting
Lund, Sweden, 221 85
Contact: Katarina Lundqvist, PhD, MD     +46 46 17 21 13     katarina.lundqvist@skane.se    
Principal Investigator: Katarina Lundqvist, PhD, MD            
Department of Medical Sciences, Section of Dermatology and Venereology, Uppsala University hospital Not yet recruiting
Uppsala, Sweden, 751 05
Contact: Ola Rollman, PhD, MD     +46 18 611 50 86     ola.rollman@medsci.uu.se    
Principal Investigator: Ola Rollman, PhD, MD            
Department of Dermatology and Infectious diseases Not yet recruiting
Halmstad, Sweden, 301 85
Contact: Karin Andersson, MD     +46 35 13 42 50     karin.andersson@lthalland.se    
Principal Investigator: Karin Andersson, MD            
Sponsors and Collaborators
Tripep 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

No publications provided

Responsible Party: Tripep AB ( Jan Nilsson/CEO )
Study ID Numbers: CS-201, EudraCT No. 2007-002695-34
Study First Received: November 24, 2008
Last Updated: December 21, 2008
ClinicalTrials.gov Identifier: NCT00797706     History of Changes
Health Authority: Norway: Norwegian Medicines Agency;   Sweden: Medical Products Agency

Study placed in the following topic categories:
Skin Diseases
Ulcer
Mitogens
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:
Pathologic Processes
Skin Diseases
Ulcer
Skin Ulcer
Leg Ulcer

ClinicalTrials.gov processed this record on May 07, 2009