NCT01528306撤回2 期
An Exploratory, Cross-Over Study of the Safety of HP802-247 Applied to Open Wounds of Subjects With Dystrophic Epidermolysis Bullosa
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Healthpoint
- 主要终点
- Time to healing
研究概览
简要总结
This is a pilot study designed to see if HP802-247, an investigational treatment with living human skin cells, helps to heal blisters or wounds in subjects with Dystrophic Epidermolysis Bullosa (DEB). The durability of the skin in healed wounds treated with HP802-247 will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written consent must be obtained from a parent or legally authorized representative. Assent will be obtained according to local requirements.
- •Subjects with a clinical diagnosis of DEB with recurring blisters, ≥ 2 years of age at Screening. Subjects may be of either sex and of any race or skin type provided that their skin color, in the opinion of the Investigator, will not interfere with the study assessments.
- •A parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits.
- •A parent or legally authorized representative must be able to follow instructions.
- •Have an open wound for ≤ 72 hours that:
- •is still open and has not scabbed or crusted over
- •has no dermatologic disease and/or condition in the treatment area (other than DEB with recurring blisters), including active or recent infection (within 7 days) that may be exacerbated by treatment, require treatment with antibiotics / antifungals /antivirals, require a surgical intervention, or cause difficulty with examination
- •is ≥ 4 cm² and ≤ 48 cm2 in total area (open portion)
- •Females of childbearing potential (defined as post-menarcheal as documented in the medical history) may participate in the study if they meet all of the following conditions:
- •they are not breast feeding;
- •they have a negative urine pregnancy test at Week 1 Period 1;
- •they agree to undertake scheduled urine pregnancy tests at Week 1 for Periods 1, 2, & 3 and at study exit
- •they do not intend to become pregnant during the study;
- •they are using adequate birth control methods and they agree to continue using those methods for the duration of the study
- •A parent or legally authorized representative must be willing and able to ensure subject is present for all required study visits (for minor subjects)
- •A parent or legally authorized representative must be able to follow instructions (for minor subjects)
排除标准
- •Contraindications or hypersensitivity to the use of the test article, their components (e.g., aprotinin, fibrinogen), or substances used in the manufacture of the test article (e.g., penicillin, streptomycin, amphotericin B, bovine serum albumin).
- •Therapy with another investigational agent within thirty (30) days of the Screening Visit, or during the study.
- •Have uncontrolled intercurrent or chronic illness that, in the opinion of the Investigator, would limit compliance with study requirements, represents a potential safety risk, or require treatment with an excluded drug/treatment.
- •The Investigator or Medical Monitor may declare any subject ineligible for a valid medical reason.
结局指标
主要结局
Time to healing
时间窗: 4 weeks
Time to healing, defined as the number of days between wound onset (caregiver reported) and complete epithelialization (Investigator assessed).
次要结局
- Percent of change in wound area(4 weeks for each of 3 treatment periods)
- Wound pain as measured by faces pain scale(4 weeks for each of 3 treatment periods)
- Persistence of healing(4 weeks for each of 3 treatment periods)
- Burning and stinging upon application(4 weeks for each of 3 treatment periods)
研究者
相似试验
进行中（未招募）
不适用
First In Human Study for Small to Medium-sized Abdominal Aortic Aneurysm (AAA)Dilation AortaAbdominal Aortic AneurysmAAANCT05133492Nectero Medical, Inc.46
进行中（未招募）
不适用
A pilot study to investigate the safety and efficacy of a combined treatment with Gemcitabine and Sulfasalazine in pancreatic ductal adenocarcinomaPancreatic ductal adenocarcinoma, non resectableMedDRA version: 9.1Level: LLTClassification code 10033600Term: Pancreatic adenocarcinoma non-resectableEUCTR2006-005104-14-DEniversitätsklinikum Schleswig-Holstein20
进行中（未招募）
不适用
Study of NanoKnife for Ablation of Prostate Cancer in Intermediate Risk PatientsProstate CancerNCT01972867Angiodynamics, Inc.6
终止
3 期
Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg UlcersVenous UlcerVenous Stasis UlcerUlcerNCT01853384Healthpoint252
已完成
1 期
Platelet rich plasma transplantation for the tooth transplantatioJPRN-jRCTc030190276Tobita Morikuni2