Port-Wine StainPhase 4NCT03181984
Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
A Phase 4 study testing Hemoporfin in people with Port-Wine Stain, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 7 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Port-Wine Stain
- What is being tested?
- Hemoporfin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 501 participants
- Where
- 7 sitesChina
- Study dates
- 31 Aug 2017to 19 Apr 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Peking University First Hospital
Beijing, 100034
PLA Army General Hospital
Beijing
West China Hospital, Sichuan University
Chengdu, Sichuan
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Shanghai Dermatology Hospital
Shanghai
Affiliated Hospital of Hebei Medical College of traditional Chinese Medicine
Shijiazhuang, Herbei
Wuxi People's Hospital
Wuxi, Jiangsu
About this study
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
- Being tested
- Hemoporfin
- Medical subject headings
- Port-Wine Stain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoporfinDrug
Hemoporfin mediated photodynamic therapy
| Study group | Role | What they receive |
|---|---|---|
| Hemoporfin | Experimental | Not described Receives: Drug: Hemoporfin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events
Measured: 96 weeks after hemoporfin application
Secondary outcomes (3)
Satisfaction rating of the overall treatment by subjects
Measured: 8, 24 and 96 weeks after hemoporfin application
Satisfaction rating of the overall treatment by investigators
Measured: 8 weeks after hemoporfin application
Response rate
proportion of patients achieving at least some improvement (color blanching from the baseline >= 20%)
Measured: 8 weeks after hemoporfin application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start31 Aug 2017
- Primary completion19 Apr 2023
- Study completion19 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Port-Wine StainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 501 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xuejun Zhu, Principal investigator, Peking University First HospitalJining Tao, Study director, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03181984
- Sponsor's protocol ID
- HMME-S1612
- Status last verified
- Dec 2023
- First submitted
- 2 Jun 2017
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postmarketing Safety Study of Hemoporfin in Patients With Port Wine Stain
- ClinicalTrials.gov ID
- NCT03181984
- Acronym / sponsor ID
- HMME-S1612
- Conditions
- Port-Wine Stain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 19 Apr 2023 (actual)
- Study completion
- 19 Apr 2023 (actual)
- First posted
- 9 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemoporfin | Experimental | Drug: Hemoporfin |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemoporfinHemoporfin mediated photodynamic therapy | Drug | Hemoporfin |
Primary outcome
Number of participants with treatment-related adverse events
Time frame: 96 weeks after hemoporfin application
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xuejun Zhu principal investigator
Peking University First Hospital
Jining Tao study director
Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hemoporfin in people with Port-Wine Stain, run by Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events (time frame: 96 weeks after hemoporfin application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2023.