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Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain

NCT03181984 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2023-12-20

No results posted yet for this study

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.

Conditions

  • Port-Wine Stain

Interventions

DRUG

Hemoporfin

Hemoporfin mediated photodynamic therapy

Sponsors & Collaborators

  • Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xuejun Zhu · Peking University First Hospital

  • Jining Tao · Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2023-04-19
Completion
2023-04-19

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03181984 on ClinicalTrials.gov