NL-OMON46073撤回不适用
A Multi-center Study to Evaluate the Pharmacokinetics of Diacerein and Rhein and the Safety of Diacerein after Maximum Use, Topical Administration of CCP-020 (Diacerein 1% ointment) to Patients with Epidermolysis Bullosa (EB) - CCP2101
Castle Creek Pharmaceuticals, LLC0 个研究点目标入组 8 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •1. Subject/caregiver is able to comprehend and willing to sign an Informed Consent and/or Assent Form.
- •2. Subject is male or female at least 12 years of age (Cohort 1) or at least 6 months of age to 11 years, inclusive (Cohort 2) at screening.
- •3. The subject must weigh at least 9 kg (19.8 lbs) at Screening.
- •4. Subject has a documented genetic mutation consistent with EB. A blood or saliva sample will be collected for genetic confirmation if no documented gene mutation data is available.
- •5. Subject has EB lesions on * 2% body surface area (BSA) and the EB lesions are in the following body areas:
- •a. Localized: plantar and/or palmar areas
- •b. Generalized: arms, legs, torso, hands and feet.
- •6. Subject/caregiver agrees to not apply any other topical products to the application area during the treatment period
- •7. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control, as defined by this protocol, for the duration of the study.
- •8. Subject is non-pregnant, non-lactating and is not planning for pregnancy during the study period
- •9. Subject is in good general health and free of any known disease state or physical condition which, in the investigator*s opinion, which exposes the subject to an unacceptable risk by study participation.
- •10. Subject is willing and able to follow all study instructions and to attend all study visits.
排除标准
- •1. Subject has EB lesions where drug will be applied that are infected (i.e., EB lesions that require anti-microbial therapy to treat an infection)
- •2. Subject has used any diacerein containing product within 1 month prior to Visit 1
- •3. Subject has used systemic immunotherapy or cytotoxic chemotherapy within 60 days prior to dosing.
- •4. Subject has used systemic steroidal therapy or has used topical steroidal therapy on the EB lesions in the application area within 14 days prior to dosing (Note: inhaled, nasal sprays, and ophthalmic products containing steroids are allowed)
- •5. Subject has evidence of a systemic infection or has used systemic antibiotics within 7 days prior to dosing
- •6. Subject has used any systemic diuretics or cardiac glycosides or any systemic product that, in the opinion of the investigator, might put the subject at undue risk by study participation or interferes with the study medication application or the study assessments within 30 days prior to dosing
- •7. Subject has a current malignancy, or a history of treatment for a malignancy within 2 years prior to dosing (Note: does not include non-melanoma skin cancer)
- •8. Subject currently has diabetes mellitus (HbA1c *6.5%) Note: controlled diabetes (HbA1c < 6.5%) is also considered exclusionary
- •9. Subject has a history of cardiac, hepatic (ALT and or AST >2x ULN, Total bilirubin >1.5x ULN at Visit 1), or renal disease (eGFR<30 ml/min/1.73 m2 [MDRD-adults *18, Bedside Schwartz * children <18]) that, in the opinion of the investigator, might put the subject at undue risk by study participation or interferes with the study medication application of the study assessments
- •10. Subject has an active non-EB skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn) that, in the opinion of the investigator, would put the subject at undue risk by study participation or would interfere with the study medication application or the study assessments
- •11. Subject has a history of sensitivity to any of the ingredients in the study medication
- •12. Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to dosing
研究者
相似试验
进行中（未招募）
1 期
A Multi-center Study to Evaluate How CCP-020 (Diacerein 1% ointment) is Absorbed in the Blood and Removed from the Body in Patients with Epidermolysis Bullosa (EB)EUCTR2018-000439-29-NLCastle Creek Pharmaceuticals, LLC20
进行中（未招募）
1 期
A Multi-center Study to Evaluate How CCP-020 (Diacerein 1% ointment) is Absorbed in the Blood and Removed from the Body in Patients with Epidermolysis Bullosa (EB)EUCTR2018-000439-29-GBCastle Creek Pharmaceuticals, LLC4
已完成
1 期
A Multiple Dose Study Evaluating the Pharmacokinetics of an Oral Tablet Formulation of BNC210 in Healthy VolunteersMental Health - Other mental health disordersTrauma and- stressor-related disordersMental Health - AnxietyAnxiety DisordersACTRN12621000125820Bionomics Limited10
已完成
不适用
A prospective Single-center Study of Pharmacokinetics and Pharmacogenetics of Regorafenib in Patients with Metastatic Colorectal CancerMetastatic Colorectal CancerJPRN-UMIN000032725Cancer Institute Hospital of Japanese Foundation for Cancer Research30
进行中（未招募）
不适用
A Study of Aprepitant in Pediatric Patients Undergoing SurgeryPrevention of Postoperative nausea and vomiting in pediatric patients.MedDRA version: 14.0Level: LLTClassification code 10036901Term: Prophylaxis against postoperative nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2008-003178-17-Outside-EU/EEA92