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Clinical Utility Of Genetic Screening For HLA-B*1301, On Susceptibility To Dapsone Hypersensitivity Syndrome

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ClinicalTrials.gov Identifier: NCT02550080
Recruitment Status : Recruiting
First Posted : September 15, 2015
Last Update Posted : March 3, 2017
Sponsor:
Collaborators:
Shandong Provincial Hospital
Jinan Central Hospital
Shandong Qianfo Hospital
Jinan Military General Hospital
Qingdao Center Medical Group
Liaocheng People's Hospital
Dongying People's Hospital,Shandong
Shandong Jining No.1 People's Hospital
Dezhou People's Hospital,Shandong
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
Information provided by (Responsible Party):
Shandong Provincial Institute of Dermatology and Venereology

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.

Condition or disease Intervention/treatment Phase
Allergic Cutaneous Vasculitis Urticaria Psoriasis Acne Bullous Skin Diseases Sterile Pustulosis Leprosy Pneumocystis Pneumonia Drug: Dapsone Genetic: HLA-B*1301 Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Study Start Date : July 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : May 2019


Arm Intervention/treatment
Experimental: The prospective genetic screening arm
Prospective HLA-B*1301 screen before administrated treatment included dapsone
Drug: Dapsone
For the HLA-B*1301 positive subjects, dapsone will not be administrated.

Genetic: HLA-B*1301
The prospective genetic screening group will be tested before administrating dapsone

Active Comparator: The control arm
No HLA-B*1301 screen before administrated treatment included dapsone
Drug: Dapsone
For the HLA-B*1301 positive subjects, dapsone will not be administrated.




Primary Outcome Measures :
  1. 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).

  2. 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).



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02550080


Contacts
Contact: Yonghu Sun, PhD +86-531-87298870 hongyue2519@hotmail.com
Contact: Hong Liu, PhD +86-531-87298870 hongyue2519@hotmail.com

Locations
China, Shandong
Shandong Provincial Institute of Dermatology and Venereology Recruiting
Jinan, Shandong, China, 250000
Contact: Furen Zhang    +86-531-87298808    zhangfuren@hotmail.com   
Sponsors and Collaborators
Shandong Provincial Institute of Dermatology and Venereology
Shandong Provincial Hospital
Jinan Central Hospital
Shandong Qianfo Hospital
Jinan Military General Hospital
Qingdao Center Medical Group
Liaocheng People's Hospital
Dongying People's Hospital,Shandong
Shandong Jining No.1 People's Hospital
Dezhou People's Hospital,Shandong
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
Investigators
Study Chair: Furen Zhang Shandong Provincial Institute of Dermatology and Venereology

Responsible Party: Shandong Provincial Institute of Dermatology and Venereology
ClinicalTrials.gov Identifier: NCT02550080     History of Changes
Other Study ID Numbers: SDPIDV-DDS-001
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Urticaria
Psoriasis
Pneumonia
Hypersensitivity
Disease Susceptibility
Vasculitis
Skin Diseases
Pneumonia, Pneumocystis
Leprosy
Drug Hypersensitivity Syndrome
Skin Diseases, Vesiculobullous
Vasculitis, Leukocytoclastic, Cutaneous
Skin Diseases, Papulosquamous
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Immune System Diseases
Disease Attributes
Pathologic Processes
Skin Diseases, Vascular
Hypersensitivity, Immediate
Vascular Diseases
Cardiovascular Diseases
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections