Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

Phase 4

Completed

• Conditions: Port-Wine Stain
• Interventions: Drug: Hemoporfin

• Registration Number: NCT03181984
• Lead Sponsor: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-02
• Study First Submitted QC: 2017-06-07
• Study First Posted: 2017-06-09
• Study Start: 2017-08-31
• Primary Completion: 2023-04-19
• Study Completion: 2023-04-19
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-18
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 501

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hemoporfin	Hemoporfin	-

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	96 weeks after hemoporfin application

Secondary Outcome Measures

Name	Time	Method
Satisfaction rating of the overall treatment by investigators	8 weeks after hemoporfin application
Satisfaction rating of the overall treatment by subjects	8, 24 and 96 weeks after hemoporfin application
Response rate	8 weeks after hemoporfin application	proportion of patients achieving at least some improvement (color blanching from the baseline \>= 20%)

Trial Locations

Locations (7)

PLA Army General Hospital; 🇨🇳 Beijing, China

Shanghai Dermatology Hospital; 🇨🇳 Shanghai, China

Affiliated Hospital of Hebei Medical College of traditional Chinese Medicine; 🇨🇳 Shijiazhuang, Herbei, China

The 2nd Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Wuxi People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Peking University First Hospital; 🇨🇳 Beijing, China