Back to resultsPostmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
Primary Purpose
Port-Wine Stain
Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Hemoporfin
Sponsored by
About this trial
This is an interventional treatment trial for Port-Wine Stain
Eligibility Criteria
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
Sites / Locations
- The 2nd Affiliated Hospital of Harbin Medical University
- Affiliated Hospital of Hebei Medical College of traditional Chinese Medicine
- Wuxi People's Hospital
- West China Hospital, Sichuan University
- Peking University First Hospital
- PLA Army General Hospital
- Shanghai Dermatology Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hemoporfin
Arm Description
Outcomes
Primary Outcome Measures
Number of participants with treatment-related adverse events
Secondary Outcome Measures
Satisfaction rating of the overall treatment by subjects
Satisfaction rating of the overall treatment by investigators
Response rate
proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)
Full Information
NCT ID
NCT03181984
First Posted
June 2, 2017
Last Updated
March 14, 2022
Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03181984
Brief Title
Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
Official Title
Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 31, 2017 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Port-Wine Stain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
501 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hemoporfin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Hemoporfin
Intervention Description
Hemoporfin mediated photodynamic therapy
Primary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events
Time Frame
96 weeks after hemoporfin application
Secondary Outcome Measure Information:
Title
Satisfaction rating of the overall treatment by subjects
Time Frame
8, 24 and 96 weeks after hemoporfin application
Title
Satisfaction rating of the overall treatment by investigators
Time Frame
8 weeks after hemoporfin application
Title
Response rate
Description
proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)
Time Frame
8 weeks after hemoporfin application
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xuejun Zhu
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jining Tao
Organizational Affiliation
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
The 2nd Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Affiliated Hospital of Hebei Medical College of traditional Chinese Medicine
City
Shijiazhuang
State/Province
Herbei
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
PLA Army General Hospital
City
Beijing
Country
China
Facility Name
Shanghai Dermatology Hospital
City
Shanghai
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
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