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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.

Tracking Information
First Submitted Date  ICMJE June 2, 2017
First Posted Date  ICMJE June 9, 2017
Last Update Posted Date August 13, 2020
Actual Study Start Date  ICMJE August 31, 2017
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 7, 2017)		 Number of participants with treatment-related adverse events [ Time Frame: 96 weeks after hemoporfin application ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 7, 2017)
  • Satisfaction rating of the overall treatment by subjects [ Time Frame: 8, 24 and 96 weeks after hemoporfin application ]
  • Satisfaction rating of the overall treatment by investigators [ Time Frame: 8 weeks after hemoporfin application ]
  • Response rate [ Time Frame: 8 weeks after hemoporfin application ]
    proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
Official Title  ICMJE Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Port-Wine Stain
Intervention  ICMJE Drug: Hemoporfin
Hemoporfin mediated photodynamic therapy
Study Arms  ICMJE Experimental: Hemoporfin
Intervention: Drug: Hemoporfin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 7, 2017)		 1500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jining Tao +86 21 58953355 jntao@d-zj.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03181984
Other Study ID Numbers  ICMJE HMME-S1612
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xuejun Zhu Peking University First Hospital
Study Director: Jining Tao Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
PRS Account Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP