Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.; Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co.,Ltd.

Criteria

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