Chronic Venous Leg UlcersPhase 1/2NCT00797706
Phase I/II Dose Ranging CHRONSEAL® Study in Venous Leg Ulcers
A Phase 1/2 study testing CHRONSEAL in people with Chronic Venous Leg Ulcers, run by Kringle Pharma Europe AB at 16 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Venous Leg Ulcers
- What is being tested?
- CHRONSEAL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 16 sitesin 2 countries
- Study dates
- Nov 2008to Mar 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Subject likely to co-operate.
- Ulcer area reduction less than 50% during run-in period.
- Ulcer area 3-20 cm2.
Who cannot join
- 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.
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- 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.
- 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
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
Sweden12 sites
Vårdcentralen Alvesta
Alvesta, 342 30
Danderyds Sjukhus AB
Danderyd, SE-182 88
Carema Vårdcentral Gubbängen
Enskede, SE-122 45
Department of Dermatology and Infectious diseases
Halmstad, SE-301 85
Husläkarna i Kungsbacka
Kungsbacka, SE-434 30
Department of Dermatology, Lund University hospital
Lund, SE-221 85
Department of Dermatology, University Hospital MAS
Malmö, SE-205 02
Gamla Stans Vårdcentral
Stockholm, SE-111 29
Taptogatans Husläkare
Stockholm, SE-115 26
Department of Dermatology, Norrlands University hospital
Umeå, SE-901 85
Department of Medical Sciences, Section of Dermatology and Venereology, Uppsala University hospital
Uppsala, SE-751 05
Neptunuskliniken
Varberg, SE-432 44
Norway4 sites
Medi3 Innlandet AS, Department Elverum
Elverum, 2402
Hudavdelingen Helse
Førde, 6807
Medi 3 Innlandet AS, Department Hamar
Hamar, 2317
Colosseumklinikken
Oslo, 0369
About this study
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
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.
- Conditions
- Chronic Venous Leg Ulcers
- Being tested
- CHRONSEAL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHRONSEALDrug
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | Not described Receives: Drug: CHRONSEAL |
| Low dose | Experimental | Not described Receives: Drug: CHRONSEAL |
| High dose | Experimental | Not described Receives: Drug: CHRONSEAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From start of treatment to 12 weeks post treatment
Secondary outcomes (1)
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.
Measured: From start of treatment to 12 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous Leg UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kringle Pharma Europe AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kringle Pharma, Inc.
- Investigators
- Hans Olav Høivik, MD, Principal investigator, Medi 3 Innlandet AS, avd HamarKarin Andersson, MD, Principal investigator, Halland County Council, Department of Dermatology and Infectious diseases, Halmstad, SwedenJan Apelqvist, Assoc. Prof., PhD, MD, Study chair, Department of Endocrinology, University Hospital Malmö,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00797706
- Sponsor's protocol ID
- CS-201
- Other IDs
- EudraCT No. 2007-002695-34
- Status last verified
- Feb 2010
- First submitted
- 24 Nov 2008
- Last updated
- 5 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00797706
- Acronym / sponsor ID
- CS-201
- Conditions
- Chronic Venous Leg Ulcers
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Kringle Pharma Europe ABIndustry (pharma, biotech, devices)
- Collaborators
- Kringle Pharma, Inc.
- Study start
- Nov 2008
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 25 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: CHRONSEAL |
| Low dose | Experimental | Drug: CHRONSEAL |
| High dose | Experimental | Drug: CHRONSEAL |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHRONSEALCream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions | Drug | High dose, Low dose, Vehicle |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Olav Høivik, MD principal investigator
Medi 3 Innlandet AS, avd Hamar
Karin Andersson, MD principal investigator
Halland County Council, Department of Dermatology and Infectious diseases, Halmstad, Sweden
Jan Apelqvist, Assoc. Prof., PhD, MD study chair
Department of Endocrinology, University Hospital Malmö,
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CHRONSEAL in people with Chronic Venous Leg Ulcers, run by Kringle Pharma Europe AB at 16 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Sweden, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2010.