Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

Shanghai Fudan-Zhangjiang Bio-Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Port-Wine Stain

Treatments: Drug: Hemoporfin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03181984

HMME-S1612

Details and patient eligibility

About

This study is to provide safety information of hemoporfin during the post-marketing period as required by China Food and Drug Administration (CFDA) regulations in order to identify any potential drug related treatment factors in the Chinese population, such as unknown/unexpected adverse reactions, the incidence of adverse reactions under the routine drug uses.

Enrollment: 501 patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age range: 14 to 65 years-old；
• Clinically diagnosed of Port-wine Stain;
• Patients receiving hemoporfin based upon the clinical judgment of the investigator;
• Written informed consent signed and agreed to receive periodic follow-up

Exclusion criteria

• Allergy to porphyrins and analogues; Photosensitivity; Porphyria; Allergic constitution;
• Scar diathesis;
• Pregnancy or unwilling to adopt reliable contraceptive measures during the month after drug application;
• Be judged not suitable to participate the study by the investigators

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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501 participants in 1 patient group

Hemoporfin

Experimental group

Treatment:

Drug: Hemoporfin