pharmacogenomics of Azathioprine induced myelosuppression in the treatment of Pemphigus Vulgaris--study of mutation in TPMT*3 and NUDT15 gene in Chinese people and changes in blood configuration(hemogram).

• Register: ChiCTR
• Last refreshed on: 21 August 2017
• Main ID: ChiCTR-OIC-17011759
• Date of registration: 2017-06-26
• Prospective Registration: No
• Primary sponsor: Dermatological Department, West China hospital, Sichuan University
• Public title: pharmacogenomics of Azathioprine induced myelosuppression in the treatment of Pemphigus Vulgaris--study of mutation in TPMT*3 and NUDT15 gene in Chinese people and changes in blood configuration(hemogram).
• Scientific title: pharmacogenomics of Azathioprine induced myelosuppression in the treatment of Pemphigus Vulgaris--study of mutation in TPMT*3 and NUDT15 gene in Chinese people and changes in blood configuration(hemogram).
• Date of first enrolment: 2016-08-01
• Target sample size: Case series:60;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=19924
• Study type: Observational study
• Study design: Case series
• Phase: I (Phase I study)

Countries of recruitment

China

Contacts

• Name: Wei Li
• Affiliation: Dermatological Department, West China hospital, Sichuan University

• Name: Li Ding
• Affiliation: Dermatological Department, West China hospital, Sichuan University

Key inclusion & exclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years (exclude 65 years), include both gender;
2. The patients were diagnosed as Pemphigus Vulgaris based on clinical manifestation,histopathology,immune pathology and detection of specific antibodies by ELISA;
3. Volunteer to participate in this project and be able to follow the requirement;
4. Signed formed consent ,and be able to follow according to the requirement.
Exclusion criteria: (1) The patients with severe cardiac,pulmonary,liver,renal,nervous or mental disease;
(2) The patients with history of AZA allergy or allergy of any kind;
(3) The patient with definite evidence of having infection or metastatic tumor;
(4) The patient having history or clinical tests that shows complicated hematological disease,particularly leukocytopenia;
(5) Pregnant women,lactating mother and women of child-bearing age who are planning to get pregnant;
(6) The patient who is unable to co-operate or cannot adhere to treatment or predicted to have a poor compliance.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

Pemphigus Vulgaris

Intervention(s)

Case series:Azathioprine;

Primary Outcome(s)

blood test;

Secondary Outcome(s)

liver function;kidney function;

Source(s) of Monetary Support

the Scientific Research Staring Foundation for the Returned Overseas Chinese Scholars,Ministry of China