Clinical trial
A Pilot Study of Hemoporfin Photodynamic Therapy in Children (2-7 Years Old) With Port-wine Stain
Name
HMME-C1904
Description
This pilot study aims to evaluate the safety and efficacy of hemoporfin photodynamic therapy (PDT) with different light doses for port-wine stain (PWS）in 2-7 years old children. The pharmacokinetic behavior and pharmacokinetic parameters of hemoporfin in children will be investigated as well.
Trial arms
Trial start
2020-05-27
Estimated PCD
2023-02-15
Trial end
2023-02-15
Status
Completed
Phase
Early phase I
Treatment
Hemoporfin PDT
Photodynamic therapy is performed using hemoporfin under general anesthesia. Hemoporfin（5mg/kg）is infused for 20 minutes, followed by light illumination at 10 minutes from the start of infusion. Different light dose of PDT is applied to the patients.
Arms:
high light dose, low light dose
Size
40
Primary endpoint
Response rate
week 8
Incidence of adverse events and adverse reactions
up to 24 weeks after the treatment
Eligibility criteria
Inclusion Criteria:
* Children with clinical diagnosis of PWS；
* ≥2 years old and \<7 years old；
* The guardians agreed to voluntarily participate in this study and signed the informed consent agreement
Exclusion Criteria:
* Therapy area located outside of head and neck;
* Other skin diseases that might interfere with the efficacy evaluation;
* Patients with respiratory disease, severe pulmonary dysfunction, history of airway hyperresponsiveness, or family history of suspected malignant hyperthermia;
* Preexist scars in the treatment area caused by previous treatment, which might interfere with the efficacy and safety evaluation;
* with allergic diseases; known to be allergic to eggs, milk or soy protein; known to have skin photoallergies, porphyria or known allergic history of experimental drugs (porphyrins) and chemically structure similar drugs; known allergic history of anesthetics; allergic constitution;
* Cicatricial constitution;
* Immunocompromised conditions or need long-term use of glucocorticoids and immunosuppressive agents;
* Electrocardiographic abnormalities or organic heart diseases;
* Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin \> 1.5 upper limit of normal \[ULN\], or serum creatinine or blood urea nitrogen \> 1.5 ULN);
* Coagulation disorders;
* Patients with severe neurological, psychiatric, endocrine and cardiovascular diseases; with epilepsy history or recent epileptic seizures;
* Be evaluated not suitable for anaesthesia by risk assessment before anaesthesia；
* Previous therapy of PWS within the last 4 weeks;
* Participation in any clinical studies within the last 4 weeks;
* Be judged not suitable to participate the study by the investigators
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-12-20
1 organization
1 product
1 indication
Organization
Shanghai Fudan-Zhangjiang Bio-PharmaceuticalProduct
HemoporfinIndication
Port-wine stain