EUCTR2007-002695-34-SE进行中（未招募）不适用
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 - Phase I/II Dose Ranging CHRONSEAL® Study in venous leg ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •RUN-IN PERIOD
- •INCLUSION CRITERIA - SUBJECT
- •1.Caucasian male or clinically sterile female subjects (postmenopausal > 12 months (confirmed as FSH > 30 mU/ml if in doubt), hysterectomy or tubal ligation)
- •2.40 years or older.
- •3.Ankle brachial index of at least 0.6.
- •4.Written informed consent obtained, and a copy provided to the subject.
- •5.Subject legally competent and able to communicate effectively with the study personnel.
- •6.Subject likely to co-operate.
- •INCLUSION CRITERIA - TARGET ULCER (= the worst ulcer to fulfil the inclusion criteria)
- •7.Uncomplicated venous ulcer as by clinical diagnosis.
- •8.Full skin ulcer.
- •9.Localisation above the foot and below the knee (wrist and malleole included)
- •10.Duration of at least 3 months.
- •11.Area 3-20 cm2.
- •RANDOMISATION (after fulfilled run-in period)
- •INCLUSION CRITERIA - SUBJECT
- •1.Subject likely to co-operate.
- •INCLUSION CRITERIA - TARGET ULCER
- •2.Ulcer area reduction less than 50% during run-in period.
- •3.Ulcer area 3-20 cm2.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •RUN-IN PERIOD
- •EXCLUSION CRITERIA - TARGET ULCER (= the worst ulcer to fulfil inclusion criteria)
- •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 e.g. placement difficult for photography, multiple close ulcers, or tissue undermining/sinus tracts.
- •4.Other known etiology of the target ulcer e.g. malignancy, vasculitis or severe clinical overt ischemia.
- •EXCLUSION CRITERIA - SUBJECT
- •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 invasive squamos epithelia carcinoma
- •17.Diagnoses of a serious psychiatric illness which may influence study participation.
- •RANDOMISATION (after fulfilled run-in period)
- •EXCLUSION CRITERIA - TARGET ULCER
- •1.Visible signs of infection, black necrosis or discharge in the target ulcer.
- •2.More than ~20% of the ulcer area slough after debridement.
- •EXCLUSION CRITERIA - SUBJECT
- •3.Subject having to the discretion of the investigator clinically significant findings on vital signs or laboratory values.
- •4.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.
- •5.Concomitant systemic treatment within 14 days prior to start of study medication with immunosuppressives
- •6.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
- •7.Co-morbidity expected to lower compliance.
- •8.Diagnosed kidney disease.
- •9.Individuals sensitive to any of the study medication components.
- •10.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.
研究者
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