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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03181984
Other study ID # HMME-S1612
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 31, 2017
Est. completion date April 19, 2023

Study information

Verified date December 2023
Source Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 501
Est. completion date April 19, 2023
Est. primary completion date April 19, 2023
Accepts healthy volunteers No
Gender All
Age group 14 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Hemoporfin
Hemoporfin mediated photodynamic therapy

Locations

Country Name City State
China Peking University First Hospital Beijing
China PLA Army General Hospital Beijing
China West China Hospital, Sichuan University Chengdu Sichuan
China The 2nd Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
China Shanghai Dermatology Hospital Shanghai
China Affiliated Hospital of Hebei Medical College of traditional Chinese Medicine Shijiazhuang Herbei
China Wuxi People's Hospital Wuxi Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with treatment-related adverse events 96 weeks after hemoporfin application
Secondary Satisfaction rating of the overall treatment by subjects 8, 24 and 96 weeks after hemoporfin application
Secondary Satisfaction rating of the overall treatment by investigators 8 weeks after hemoporfin application
Secondary Response rate proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%) 8 weeks after hemoporfin application
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