NCT05380635已完成2 期
Phase 2a Study of Systemic PK and Serial ECG Determinations Following 8 Weeks of HyBryte Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Soligenix
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Electrocardiograms (ECG)
研究概览
简要总结
To assess the blood levels of hypericin and any electrocardiogram (ECG) changes during 8 weeks of HyBryte (topical hypericin ointment) photodynamic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of cutaneous T-cell lymphoma (CTCL, mycosis fungoides), Stage IB or Stage IIA
- •CTCL lesions covering ≥ 10% of their body surface area
排除标准
- •History of allergy or hypersensitivity to any of the components of HyBryte
- •Pregnancy or mothers who are breast-feeding
- •Males and females not willing to use effective contraception
- •Subjects with history of sun hypersensitivity or photosensitive dermatoses (e.g., porphyria, systemic lupus erythematosus (SLE), Sjogren's syndrome, etc.)
- •Subjects whose condition is spontaneously improving
- •Subjects receiving topical steroids or other topical treatments (e.g., nitrogen mustard) on index lesions for CTCL within 2 weeks of enrollment
- •Subjects receiving systemic steroids, psoralen ultraviolet A (UVA) radiation therapy (PUVA), narrow band ultraviolet B (UVB) light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within 3 weeks of enrollment
- •Subjects who have received electron beam irradiation within 3 months of enrollment
- •Subjects with a history of significant systemic immunosuppression
- •Subjects taking other investigational drugs or drugs of abuse within 30 days of enrollment
- •Subjects receiving drugs known to cause photosensitization within 2 weeks of starting HyBryte therapy unless they have not had evidence of photosensitization after receiving a stable dose of the medication for a minimum of 4 weeks
研究组 & 干预措施
HyBryte (0.25 % Hypericin)
Experimental
HyBryte (0.25 % hypericin) ointment will be applied to CTCL lesions and treated with visible light 18-24 hours later starting at 5 J/cm^2. Drug application/light session will be done twice a week (at least 2 calendar days apart) for 8 weeks.
干预措施: Hypericin (Drug)
结局指标
主要结局
Electrocardiograms (ECG)
时间窗: 10 weeks
Assess any ECG QT interval changes (defined as any occurrences of QT interval \>500 ms or changes in QT interval \>60 ms) during standard HyBryte photodynamic therapy.
Systemic Blood Levels
时间窗: 10 weeks
Assess the systemic blood levels of hypericin during standard HyBryte photodynamic therapy.
次要结局
- Number of Index Lesions With a Complete Response as Defined as a 100% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.(10 weeks)
- Number of Index Lesions With a Treatment Response as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.(10 weeks)
- Number of Responders and Non-Responders With a Treatment Response in 3 Treated Lesions as Defined as a ≥50% Improvement in the Composite Assessment of Index Lesion Disease Severity (CAILS) Score.(10 weeks)
研究者
研究点 (1)
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