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Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03181984
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Port-Wine Stain Drug: Hemoporfin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
Actual Study Start Date : August 31, 2017
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Hemoporfin Drug: Hemoporfin
Hemoporfin mediated photodynamic therapy


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: 96 weeks after hemoporfin application ]

Secondary Outcome Measures :
  1. Satisfaction rating of the overall treatment by subjects [ Time Frame: 8, 24 and 96 weeks after hemoporfin application ]
  2. Satisfaction rating of the overall treatment by investigators [ Time Frame: 8 weeks after hemoporfin application ]
  3. Response rate [ Time Frame: 8 weeks after hemoporfin application ]
    proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181984


Contacts
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Contact: Jining Tao +86 21 58953355 jntao@d-zj.com

Locations
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China, Heilongjiang
The 2nd Affiliated Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China
China, Herbei
Affiliated Hospital of Hebei Medical College of traditional Chinese Medicine Recruiting
Shijiazhuang, Herbei, China
China, Jiangsu
Wuxi People's Hospital Recruiting
Wuxi, Jiangsu, China
China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China
China
Peking University First Hospital Recruiting
Beijing, China, 100034
Contact: Ke Wang    +86 10 83573066      
PLA Army General Hospital Recruiting
Beijing, China
Shanghai Dermatology Hospital Recruiting
Shanghai, China
Sponsors and Collaborators
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Xuejun Zhu Peking University First Hospital
Study Director: Jining Tao Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
More Information
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Responsible Party: Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03181984    
Other Study ID Numbers: HMME-S1612
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemangioma, Capillary
Port-Wine Stain
Skin Abnormalities
Congenital Abnormalities
Skin Diseases
 Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms