Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
1 other identifier
interventional
501
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Aug 2017
Longer than P75 for phase_4
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2017
CompletedFirst Posted
Study publicly available on registry
June 9, 2017
CompletedStudy Start
First participant enrolled
August 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 19, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 19, 2023
CompletedDecember 20, 2023
December 1, 2023
5.6 years
June 2, 2017
December 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with treatment-related adverse events
96 weeks after hemoporfin application
Secondary Outcomes (3)
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
Study Arms (1)
Hemoporfin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
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, 100034, China
PLA Army General Hospital
Beijing, China
Shanghai Dermatology Hospital
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xuejun Zhu
Peking University First Hospital
- STUDY DIRECTOR
Jining Tao
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2017
First Posted
June 9, 2017
Study Start
August 31, 2017
Primary Completion
April 19, 2023
Study Completion
April 19, 2023
Last Updated
December 20, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share