Clinical Utility Of Genetic Screening For HLA-B*1301, On Susceptibility To Dapsone Hypersensitivity Syndrome
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
1 other identifier
interventional
3,130
1 country
1
Brief 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. 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 Subjects who experience suspected DHS during the 6-week observation would be withdrawn from dapsone and undergo EPT patch testing 6 weeks later.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2015
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 20, 2015
CompletedFirst Posted
Study publicly available on registry
September 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedMarch 3, 2017
March 1, 2017
3.4 years
August 20, 2015
March 1, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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).
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).
6 weeks
Study Arms (2)
The prospective genetic screening arm
EXPERIMENTALProspective HLA-B\*1301 screen before administrated treatment included dapsone
The control arm
ACTIVE COMPARATORNo HLA-B\*1301 screen before administrated treatment included dapsone
Interventions
For the HLA-B\*1301 positive subjects, dapsone will not be administrated.
The prospective genetic screening group will be tested before administrating dapsone
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shandong Provincial Institute of Dermatology and Venereologylead
- Shandong Provincial Hospitalcollaborator
- Jinan Central Hospitalcollaborator
- Shandong Qianfo Hospitalcollaborator
- Jinan Military General Hospitalcollaborator
- Qingdao Hiser Medical Groupcollaborator
- Liaocheng People's Hospitalcollaborator
- Dongying People's Hospitalcollaborator
- Jining First People's Hospitalcollaborator
- Dezhou People's Hospitalcollaborator
- Jinan City Dermatology Hospital Prevention and Treatmentcollaborator
- Linyi City Dermatology Hospital Prevention and Treatmentcollaborator
- Jining City Dermatology Hospital Prevention and Treatmentcollaborator
- Weifang City Dermatology Hospital Prevention and Treatmentcollaborator
- Laiwu City Dermatology Hospital Prevention and Treatmentcollaborator
- Rizhao City Dermatology Hospital Prevention and Treatmentcollaborator
Study Sites (1)
Shandong Provincial Institute of Dermatology and Venereology
Jinan, Shandong, 250000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Furen Zhang
Shandong Provincial Institute of Dermatology and Venereology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2015
First Posted
September 15, 2015
Study Start
July 1, 2015
Primary Completion
December 1, 2018
Study Completion
May 1, 2019
Last Updated
March 3, 2017
Record last verified: 2017-03