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

Primary Purpose

Chronic Venous Leg Ulcers

Status
Unknown status
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
CHRONSEAL
Sponsored by
Kringle Pharma Europe AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Venous Leg Ulcers

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medi3 Innlandet AS, Department Elverum
  • Hudavdelingen Helse
  • Medi 3 Innlandet AS, Department Hamar
  • Colosseumklinikken
  • Vårdcentralen Alvesta
  • Danderyds Sjukhus AB
  • Carema Vårdcentral Gubbängen
  • Department of Dermatology and Infectious diseases
  • Husläkarna i Kungsbacka
  • Department of Dermatology, Lund University hospital
  • Department of Dermatology, University Hospital MAS
  • Gamla Stans Vårdcentral
  • Taptogatans Husläkare
  • Department of Dermatology, Norrlands University hospital
  • Department of Medical Sciences, Section of Dermatology and Venereology, Uppsala University hospital
  • Neptunuskliniken

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Vehicle

Low dose

High dose

Arm Description

Outcomes

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.

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.

Full Information

First Posted
November 24, 2008
Last Updated
February 4, 2010
Sponsor
Kringle Pharma Europe AB
Collaborators
Kringle Pharma, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00797706
Brief Title
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

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
March 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Kringle Pharma Europe AB
Collaborators
Kringle Pharma, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Leg Ulcers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Title
Low dose
Arm Type
Experimental
Arm Title
High dose
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CHRONSEAL
Intervention Description
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria (Run-in period): Caucasian male or clinically sterile female subjects 40 years or older. Ankle brachial index of at least 0.6. Written informed consent obtained. Subject legally competent and able to communicate effectively. Subject likely to co-operate. Uncomplicated venous ulcer as by clinical diagnosis. Full skin ulcer. Localisation above the foot and below the knee (wrist and malleoli included) Duration of at least 3 months. Area 3-20 cm2. Exclusion criteria (Run-in period) Visible signs of infection, black necrosis or discharge in the target ulcer. More than ~20% slough after debridement. Ulcer that by location or extension will either be difficult to follow or to treat according to the protocol. Other known etiology of the target ulcer. Subject having to the discretion of the investigator clinically significant findings on physical examination or vital signs. 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. Concomitant systemic treatment within 14 days prior to start of study medication with immunosuppressives 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 Diabetes Mellitus requiring pharmaceutical treatment. Co-morbidity with a life expectancy less than 6 months. Co-morbidity expected to lower compliance. Diagnosed kidney disease Individuals sensitive to any of the study medication components. 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. Known abuse of alcohol, drugs or pharmaceuticals. Diagnosis of squamous epithelia carcinoma Diagnoses of a serious psychiatric illness which may influence study participation. Inclusion criteria (Randomization) Subject likely to co-operate. Ulcer area reduction less than 50% during run-in period. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Olav Høivik, MD
Organizational Affiliation
Medi 3 Innlandet AS, avd Hamar
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karin Andersson, MD
Organizational Affiliation
Halland County Council, Department of Dermatology and Infectious diseases, Halmstad, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Apelqvist, Assoc. Prof., PhD, MD
Organizational Affiliation
Department of Endocrinology, University Hospital Malmö,
Official's Role
Study Chair
Facility Information:
Facility Name
Medi3 Innlandet AS, Department Elverum
City
Elverum
ZIP/Postal Code
2402
Country
Norway
Facility Name
Hudavdelingen Helse
City
Førde
ZIP/Postal Code
6807
Country
Norway
Facility Name
Medi 3 Innlandet AS, Department Hamar
City
Hamar
ZIP/Postal Code
2317
Country
Norway
Facility Name
Colosseumklinikken
City
Oslo
ZIP/Postal Code
0369
Country
Norway
Facility Name
Vårdcentralen Alvesta
City
Alvesta
ZIP/Postal Code
342 30
Country
Sweden
Facility Name
Danderyds Sjukhus AB
City
Danderyd
ZIP/Postal Code
SE-182 88
Country
Sweden
Facility Name
Carema Vårdcentral Gubbängen
City
Enskede
ZIP/Postal Code
SE-122 45
Country
Sweden
Facility Name
Department of Dermatology and Infectious diseases
City
Halmstad
ZIP/Postal Code
SE-301 85
Country
Sweden
Facility Name
Husläkarna i Kungsbacka
City
Kungsbacka
ZIP/Postal Code
SE-434 30
Country
Sweden
Facility Name
Department of Dermatology, Lund University hospital
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
Facility Name
Department of Dermatology, University Hospital MAS
City
Malmö
ZIP/Postal Code
SE-205 02
Country
Sweden
Facility Name
Gamla Stans Vårdcentral
City
Stockholm
ZIP/Postal Code
SE-111 29
Country
Sweden
Facility Name
Taptogatans Husläkare
City
Stockholm
ZIP/Postal Code
SE-115 26
Country
Sweden
Facility Name
Department of Dermatology, Norrlands University hospital
City
Umeå
ZIP/Postal Code
SE-901 85
Country
Sweden
Facility Name
Department of Medical Sciences, Section of Dermatology and Venereology, Uppsala University hospital
City
Uppsala
ZIP/Postal Code
SE-751 05
Country
Sweden
Facility Name
Neptunuskliniken
City
Varberg
ZIP/Postal Code
SE-432 44
Country
Sweden

12. IPD Sharing Statement

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

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