Allergic Cutaneous VasculitisPhase 4NCT02550080
Clinical Utility Of Genetic Screening For HLA-B*1301, On Susceptibility To Dapsone Hypersensitivity Syndrome
A Phase 4 study testing Dapsone and HLA-B*1301 in people with Allergic Cutaneous Vasculitis and Urticaria, run by Shandong Provincial Institute of Dermatology and Venereology at 1 site in China.
Trial summary
This Study is to evaluate the utility of prospective HLA-B*1301 screening on the incidence of dapsone hypersensitivity syndrome (DHS) in 3130 previously Dapsone(DDS)-naive patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Cutaneous Vasculitis, Urticaria, Psoriasis
- What is being tested?
- Dapsone and HLA-B*1301
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,130 participants
- Where
- 1 siteChina
- Study dates
- Jul 2015to May 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with cutaneous vasculitis, urticaria, psoriasis, acne, bullous skin diseases, sterile pustulosis, leprosy, pneumocystis pneumonia and any other patients who need dapsone administration.
- Subjects are dapsone-naive.
- All subjects must have a clinical need for treatment with dapsone that precedes the decision to participate in the study.
- All subjects are willing to complete the 6-weeks period clinical trial.
- All subjects are written informed consent.
Who cannot join
- Has previously received Dapsone therapy.
- The subject or any of their healthcare providers is aware of the subjects HLA type.
- Has been diagnosed with Glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency
- Satisfies any contraindications or restrictions to Dapsone therapy as listed in the product labels.
- Current severe illness, including heart, liver and renal failure, major organ allograft, malignancy requiring parenteral chemotherapy that can not be discontinued for the duration of the trial, or any other conditions which, in the opinion of the Investigator, would make the patient unsuitable for the study.
- Any laboratory abnormality at Screening which, in the opinion of the Investigator, should preclude the subject's participation in the study [alanine aminotransferase (ALT), glutamic oxaloacetic transaminase(ALT), et al).
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- Pregnant women or women who are breastfeeding.
- Subject is, in the opinion of the Investigator, unable to complete the 6 week Observation period and the EPT assessments as required.
- A positive result for HLA-B*1301 in those subjects randomised to the genetic screening arm.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shandong Provincial Institute of Dermatology and Venereology
Jinan, Shandong, 250000
Furen Zhang, +86-531-87298808, zhangfuren@hotmail.com
About this study
Official title: A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*1301) for Susceptibility to Dapsone Hypersensitivity Syndrome
This Study is to evaluate the utility of prospective HLA-B*1301 screening on the incidence of dapsone hypersensitivity syndrome (DHS) in 3130 previously Dapsone(DDS)-naive patients. Those patients include allergic cutaneous vasculitis, urticaria, psoriasis, acne, bullous skin diseases, sterile pustulosis, leprosy, pneumocystis pneumonia and any other patients who need dapsone administration. The study has two (co-primary) objectives: i) to determine if screening for HLA-B*1301 prior to DDS-containing treatment results in a lower incidence of clinically-suspected DHS versus current standard of care (no genetic screening) and ii) to determine if screening for HLA-B*1301 prior to DDS-containing treatment results in a significantly lower incidence of immunologically-confirmed DHS versus current standard of care (no genetic screening or patch testing). The study consists of up to a 5-day screening period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing a suspected DHS and a subset of DDS-tolerant subjects, an epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm (prospective genetic screening: Case). Subjects identified as HLA-B*1301 positive in the prospective Genetic Screening Arm will not receive dapsone and will be excluded from further study. Subjects who experience suspected DHS during the 6-week observation would be withdrawn from dapsone and undergo EPT patch testing 6 weeks later.
- Conditions
- Allergic Cutaneous Vasculitis, Urticaria, Psoriasis, Acne, Bullous Skin Diseases, Sterile Pustulosis
- Being tested
- Dapsone, HLA-B*1301
- Medical subject headings
- Vasculitis, Leukocytoclastic, Cutaneous, Urticaria, Psoriasis, Acne Vulgaris, Skin Diseases, Vesiculobullous, Leprosy, Pneumonia, Pneumocystis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapsoneDrug
For the HLA-B*1301 positive subjects, dapsone will not be administrated.
HLA-B*1301Genetic
The prospective genetic screening group will be tested before administrating dapsone
| Study group | Role | What they receive |
|---|---|---|
| The prospective genetic screening arm | Experimental | Prospective HLA-B*1301 screen before administrated treatment included dapsone Receives: Drug: Dapsone; Genetic: HLA-B*1301 |
| The control arm | Active comparator | No HLA-B*1301 screen before administrated treatment included dapsone Receives: Drug: Dapsone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically-suspected DHS during the 6-week observation period
The primary outcome measure will be the total number of clinically suspected Dapsone induced hypersensitivity syndrome during the 6-week observation period in both the prospective-screening group and control group, as reported by the DHS incidence (DHS patients/ total participants).
Measured: 6 weeks
Incidence of immunologically-confirmed DHS during the 6-week observation period
The primary outcome measure will be the total number of immunologically confirmed Dapsone induced hypersensitivity syndrome during the 6-week observation period in both the prospective-screening group and control group, as reported by the DHS incidence (DHS patients/ total participants).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2018 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic Cutaneous VasculitisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 3,130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Institute of Dermatology and Venereology
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong Provincial Hospital, Jinan Central Hospital, Shandong Qianfo Hospital, Jinan Military General Hospital, Qingdao Hiser Medical Group, Liaocheng People's Hospital, Dongying People's Hospital, Jining First People's Hospital, Dezhou People's Hospital, Jinan City Dermatology Hospital Prevention and Treatment, Linyi City Dermatology Hospital Prevention and Treatment, Jining City Dermatology Hospital Prevention and Treatment, Weifang City Dermatology Hospital Prevention and Treatment, Laiwu City Dermatology Hospital Prevention and Treatment, Rizhao City Dermatology Hospital Prevention and Treatment
- Responsible party
- Sponsor
- Investigators
- Furen Zhang, Study chair, Shandong Provincial Institute of Dermatology and Venereology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550080
- Sponsor's protocol ID
- SDPIDV-DDS-001
- Status last verified
- Mar 2017
- First submitted
- 20 Aug 2015
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Randomised, Multicentre, Double-blind, Study to Evaluate the Clinical Utility of Prospective Genetic Screening (HLA-B*1301) for Susceptibility to Dapsone Hypersensitivity Syndrome
- ClinicalTrials.gov ID
- NCT02550080
- Acronym / sponsor ID
- SDPIDV-DDS-001
- Conditions
- Allergic Cutaneous Vasculitis, Urticaria, Psoriasis, Acne, Bullous Skin Diseases, Sterile Pustulosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,130 participants (estimated)
- Lead sponsor
- Shandong Provincial Institute of Dermatology and VenereologyUniversity, hospital or other
- Collaborators
- Shandong Provincial Hospital, Jinan Central Hospital, Shandong Qianfo Hospital, Jinan Military General Hospital, Qingdao Hiser Medical Group, Liaocheng People's Hospital, Dongying People's Hospital, Jining First People's Hospital, Dezhou People's Hospital, Jinan City Dermatology Hospital Prevention and Treatment, Linyi City Dermatology Hospital Prevention and Treatment, Jining City Dermatology Hospital Prevention and Treatment, Weifang City Dermatology Hospital Prevention and Treatment, Laiwu City Dermatology Hospital Prevention and Treatment, Rizhao City Dermatology Hospital Prevention and Treatment
- Study start
- Jul 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 15 Sep 2015 (estimated)
- 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 evaluate the utility of prospective HLA-B*1301 screening on the incidence of dapsone hypersensitivity syndrome (DHS) in 3130 previously Dapsone(DDS)-naive patients. Those patients include allergic cutaneous vasculitis, urticaria, psoriasis, acne, bullous skin diseases, sterile pustulosis, leprosy, pneumocystis pneumonia and any other patients who need dapsone administration. The study has two (co-primary) objectives: i) to determine if screening for HLA-B*1301 prior to DDS-containing treatment results in a lower incidence of clinically-suspected DHS versus current standard of care (no genetic screening) and ii) to determine if screening for HLA-B*1301 prior to DDS-containing treatment results in a significantly lower incidence of immunologically-confirmed DHS versus current standard of care (no genetic screening or patch testing). The study consists of up to a 5-day screening period, a randomised observation period (Day 1 through Week 6) and, for subjects experiencing a suspected DHS and a subset of DDS-tolerant subjects, an epicutaneous patch test (EPT) assessment period. Eligible subjects will be randomised to one of two study arms: a Current Standard of Care Arm (no prospective genetic screening: Control) and a Genetic Screening Arm (prospective genetic screening: Case). Subjects identified as HLA-B*1301 positive in the prospective Genetic Screening Arm will not receive dapsone and will be excluded from further study. Subjects who experience suspected DHS during the 6-week observation would be withdrawn from dapsone and undergo EPT patch testing 6 weeks later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The prospective genetic screening arm | Experimental | Drug: Dapsone, Genetic: HLA-B*1301Prospective HLA-B*1301 screen before administrated treatment included dapsone |
| The control arm | Active comparator | Drug: DapsoneNo HLA-B*1301 screen before administrated treatment included dapsone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with cutaneous vasculitis, urticaria, psoriasis, acne, bullous skin diseases, sterile pustulosis, leprosy, pneumocystis pneumonia and any other patients who need dapsone administration.
- Subjects are dapsone-naive.
- All subjects must have a clinical need for treatment with dapsone that precedes the decision to participate in the study.
- All subjects are willing to complete the 6-weeks period clinical trial.
- All subjects are written informed consent.
Key exclusion criteria (9 listed)
- Has previously received Dapsone therapy.
- The subject or any of their healthcare providers is aware of the subjects HLA type.
- Has been diagnosed with Glucose-6-phosphate dehydrogenase deficiency or methemoglobin reductase deficiency
- Satisfies any contraindications or restrictions to Dapsone therapy as listed in the product labels.
- Current severe illness, including heart, liver and renal failure, major organ allograft, malignancy requiring parenteral chemotherapy that can not be discontinued for the duration of the trial, or any other conditions which, in the opinion of the Investigator, would make the patient unsuitable for the study.
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 |
|---|---|---|
| DapsoneFor the HLA-B*1301 positive subjects, dapsone will not be administrated. | Drug | The control arm, The prospective genetic screening arm |
| HLA-B*1301The prospective genetic screening group will be tested before administrating dapsone | Genetic | The prospective genetic screening arm |
Primary outcome
Incidence of clinically-suspected DHS during the 6-week observation period
Time frame: 6 weeks
The primary outcome measure will be the total number of clinically suspected Dapsone induced hypersensitivity syndrome during the 6-week observation period in both the prospective-screening group and control group, as reported by the DHS incidence (DHS patients/ total participants).
Incidence of immunologically-confirmed DHS during the 6-week observation period
Time frame: 6 weeks
The primary outcome measure will be the total number of immunologically confirmed Dapsone induced hypersensitivity syndrome during the 6-week observation period in both the prospective-screening group and control group, as reported by the DHS incidence (DHS patients/ total participants).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
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.
Furen Zhang study chair
Shandong Provincial Institute of Dermatology and Venereology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapsone and HLA-B*1301 in people with Allergic Cutaneous Vasculitis and Urticaria, run by Shandong Provincial Institute of Dermatology and Venereology at 1 site 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yonghu Sun, PhD (+86-531-87298870, hongyue2519@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of clinically-suspected DHS during the 6-week observation period (time frame: 6 weeks). The study lists 2 primary outcomes in all. 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 3 Mar 2017.