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

Primary Purpose

Allergic Cutaneous Vasculitis, Urticaria, Psoriasis

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Dapsone

HLA-B*1301

About this trial

This is an interventional treatment trial for Allergic Cutaneous Vasculitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Shandong Provincial Institute of Dermatology and VenereologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

The prospective genetic screening arm

The control arm

Arm Description

Prospective HLA-B*1301 screen before administrated treatment included dapsone

No HLA-B*1301 screen before administrated treatment included dapsone

Outcomes

Primary Outcome Measures

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).

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT02550080

First Posted

August 20, 2015

Last Updated

March 1, 2017

Sponsor

Shandong Provincial Institute of Dermatology and Venereology

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,Shandong, Shandong Jining No.1 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

1. Study Identification

Unique Protocol Identification Number

NCT02550080

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shandong Provincial Institute of Dermatology and Venereology

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Cutaneous Vasculitis, Urticaria, Psoriasis, Acne, Bullous Skin Diseases, Sterile Pustulosis, Leprosy, Pneumocystis Pneumonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

3130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

The prospective genetic screening arm

Arm Type

Experimental

Arm Description

Prospective HLA-B*1301 screen before administrated treatment included dapsone

Arm Title

The control arm

Arm Type

Active Comparator

Arm Description

No HLA-B*1301 screen before administrated treatment included dapsone

Intervention Type

Drug

Intervention Name(s)

Dapsone

Intervention Description

For the HLA-B*1301 positive subjects, dapsone will not be administrated.

Intervention Type

Genetic

Intervention Name(s)

HLA-B*1301

Intervention Description

The prospective genetic screening group will be tested before administrating dapsone

Primary Outcome Measure Information:

Title

Incidence of clinically-suspected DHS during the 6-week observation period

Description

Time Frame

6 weeks

Title

Incidence of immunologically-confirmed DHS during the 6-week observation period

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yonghu Sun, PhD

Phone

+86-531-87298870

hongyue2519@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Hong Liu, PhD

Phone

+86-531-87298870

hongyue2519@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Furen Zhang

Organizational Affiliation

Shandong Provincial Institute of Dermatology and Venereology

Official's Role

Study Chair

Facility Information:

Facility Name

Shandong Provincial Institute of Dermatology and Venereology

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Furen Zhang

Phone

+86-531-87298808

zhangfuren@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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