Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

NCT03181984 — Phase 4, Completed, 501 participants, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT03181984
Status	Completed
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	501 (Actual)
Sponsor	Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. (Industry)
Conditions	Port-Wine Stain
Interventions	Hemoporfin (Drug)
Dates	start 2017-08-31, primary completion 2023-04-19, completion 2023-04-19, first posted 2017-06-09, last updated 2023-12-20
Locations	7 sites in China

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Hemoporfin	Experimental	Drug: Hemoporfin

Hemoporfin (Drug): Hemoporfin mediated photodynamic therapy

+Outcome measures

Primary outcomes

Number of participants with treatment-related adverse events [96 weeks after hemoporfin application]

Secondary outcomes

Satisfaction rating of the overall treatment by subjects [8, 24 and 96 weeks after hemoporfin application]
Satisfaction rating of the overall treatment by investigators [8 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%)

+Eligibility

Sex: All, ages: 14 Years to 65 Years

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

+Locations (7)

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

+Investigators

Xuejun Zhu, Principal investigator, Peking University First Hospital
Jining Tao, Study director, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

My Notes

Public

To Read Reading Read