EUCTR2018-000536-10-PL进行中（未招募）1 期
A Study in Patients with Hard-to-Heal Venous Leg Ulcers to Measure Efficacy and Safety of Locally Administered LL-37; A Phase IIb, Double-blind, Randomised, Placebo-controlled, Multi-centre Trial - HEAL LL-37
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 159
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
- •1. Capable and voluntarily giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Provision of signed and dated written ICF must be prior to any mandatory study specific procedures, sampling and analyses.
- •2. Male or female =18 years of age at the time of signing the ICF
- •3. Female patients must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) until the last dose of LL-37/matching placebo to prevent pregnancy. In addition, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
- •4. Negative pregnancy test (women of child-bearing potential only)
- •5. Lower leg ulcers presumed to be caused by venous insufficiency
- •6. Target leg ulcer that has failed to heal within a minimum of 6 weeks of compression therapy
- •7. Ankle-brachial pressure index (ABI) >0.70 at screening
- •8. Ulcer localisation above the foot and below the knee (ankle and malleoli included)
- •9. Surface area of target ulcer 2 to 40 cm2 at screening
- •10. Ulcer essentially free of necrotic tissue
- •11. Ability to tolerate compression bandaging
- •12. Appropriate state of health to participate in the study, as determined by the investigator. This will be determined by medical history, physical examination and clinical laboratory evaluations
- •13. Willing to attend study visits and judged able to comply with the protocol requirements
- •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 79
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. Other known predominant aetiology than VLU of the target ulcer, such as trauma
- •2. Malignant disease (excluding basal cell carcinoma) unless in remission for 5 years
- •3. P-albumin <25 g/L or HbA1c >10%
- •4. Presence of active psoriasis skin lesions within 1.5 cm of the ulcer area
- •5. Ulcer which by location or extension is either difficult to assess or treat according to the protocol
- •6. Presence of a non-study ulcer within 2 cm of the target VLU
- •7. Exposure of bone, tendon or fascia within the target ulcer
- •8. Clinical signs or symptoms of an infection of the target ulcer, erysipelas, or osteomyelitis requiring systemic antibiotic treatment
- •9. Systemic immunosuppressive drugs with the exception of low-dose oral steroids: glucocorticoids corresponding to oral prednisolone =10 mg/day are allowed provided that drug treatment has been initiated not earlier than 4 weeks prior to the screening visit and at that time point, is expected to be maintained at similar dose level throughout the study period. Also, mineral corticoids are permitted.
- •10. Known hypersensitivity to any component of the study drug or standard ulcer dressing allowed during study treatment period or follow-up period
- •11. Systemic treatment with antibiotics within 7 days prior to screening visit
- •12. Participation in another clinical study within 7 days prior to screening visit
- •13. Treatment with any of the following medications on the target ulcer on the day of screening: topical antibiotics, potassium permanganate
- •14. Presence of heavy ulcer exudation that requires more frequent dressing changes than are allowed in the study (i.e. twice weekly) as judged by the investigator
- •15. For women only: currently pregnant (confirmed by positive pregnancy test) or breast-feeding
- •16. Any clinically significant disease judged by the investigator to affect the patient’s capability to participate in the study or to possibly influence the evaluation of study data
- •Additional criterion to be checked at randomisation visit:
- •17. Reduction in the target ulcer area per week during run-in period:
- •a. >7% for an ulcer with an initial area of >10 cm2
- •b. >10% for an ulcer with an initial area of =2 to =10 cm2
研究者
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