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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Kringle Pharma Europe AB.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Kringle Pharma, Inc.
Information provided by:
Kringle Pharma Europe AB
ClinicalTrials.gov Identifier:
NCT00797706
First received: November 24, 2008
Last updated: February 4, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Chronic Venous Leg Ulcers
Drug: CHRONSEAL
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Kringle Pharma Europe AB:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: November 2008
Estimated Study Completion Date: March 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years and older
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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797706

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

No publications provided

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
Study First Received: November 24, 2008
Last Updated: February 4, 2010
Health Authority: Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Varicose Ulcer
Cardiovascular Diseases
Pathologic Processes
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014