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

November 24, 2008
February 4, 2010
November 2008
March 2010   (final data collection date for primary outcome 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. [ Time Frame: From start of treatment to 12 weeks post treatment ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00797706 on ClinicalTrials.gov Archive Site
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 ]
  • 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 ]
Not Provided
Not Provided
 
Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Venous Leg Ulcers
Drug: CHRONSEAL
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
  • Placebo Comparator: Vehicle
    Intervention: Drug: CHRONSEAL
  • Experimental: Low dose
    Intervention: Drug: CHRONSEAL
  • Experimental: High dose
    Intervention: Drug: CHRONSEAL
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
March 2010
March 2010   (final data collection date for primary outcome measure)

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

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway,   Sweden
 
NCT00797706
CS-201, EudraCT No. 2007-002695-34
No
Prof. Anders Vahlne/CEO, Kringle Pharma Europe AB
Kringle Pharma Europe AB
Kringle Pharma, Inc.
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,
Kringle Pharma Europe AB
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP