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

February 4, 2010 updated by: Kringle Pharma Europe AB

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.

Study Overview

Status

Unknown

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Elverum, Norway, 2402
        • Medi3 Innlandet AS, Department Elverum
      • Førde, Norway, 6807
        • Hudavdelingen Helse
      • Hamar, Norway, 2317
        • Medi 3 Innlandet AS, Department Hamar
      • Oslo, Norway, 0369
        • Colosseumklinikken
      • Alvesta, Sweden, 342 30
        • Vårdcentralen Alvesta
      • Danderyd, Sweden, SE-182 88
        • Danderyds sjukhus AB
      • Enskede, Sweden, SE-122 45
        • Carema Vårdcentral Gubbängen
      • Halmstad, Sweden, SE-301 85
        • Department of Dermatology and Infectious diseases
      • Kungsbacka, Sweden, SE-434 30
        • Husläkarna i Kungsbacka
      • Lund, Sweden, SE-221 85
        • Department of Dermatology, Lund University hospital
      • Malmö, Sweden, SE-205 02
        • Department of Dermatology, University Hospital MAS
      • Stockholm, Sweden, SE-111 29
        • Gamla Stans Vårdcentral
      • Stockholm, Sweden, SE-115 26
        • Taptogatans Husläkare
      • Umeå, Sweden, SE-901 85
        • Department of Dermatology, Norrlands University hospital
      • Uppsala, Sweden, SE-751 05
        • Department of Medical Sciences, Section of Dermatology and Venereology, Uppsala University hospital
      • Varberg, Sweden, SE-432 44
        • Neptunuskliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
Experimental: Low dose
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
Experimental: High dose
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From start of treatment to 12 weeks post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From start of treatment to 12 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

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,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Anticipated)

March 1, 2010

Study Completion (Anticipated)

March 1, 2010

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Estimate)

February 5, 2010

Last Update Submitted That Met QC Criteria

February 4, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • CS-201
  • EudraCT No. 2007-002695-34

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Venous Leg Ulcers

3
Subscribe