CompletedPhase 4

Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

China501 participantsStarted 2017-08-31

Plain-language 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.

Who can participate

Age range14 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants with treatment-related adverse events

Timeframe: 96 weeks after hemoporfin application

Trial details

NCT IDNCT03181984

SponsorShanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-19

View on ClinicalTrials.gov More Port-Wine Stain trials