Overview

Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus Treatment

Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to investigate the relationship between the side effects of cyclophosphamide in the treatment of systemic lupus erythematosus (SLE) in Han Chinese and the genetic polymorphisms of drug metabolizing enzymes and pharmacokinetics of cyclophosphamide.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Collaborator:
First Affiliated Hospital, Sun Yat-Sen University
Treatments:
Cyclophosphamide
Criteria
Inclusion Criteria:

1. The patients must have been diagnosed as SLE according to the American College of
Rheumatology (ACR) criteria published in 1997.

2. The patients must sign the informed consent. And for the patients who are under 18
years old, both the signatures of their legal guardians and that of the patients are
required on the written informed consent.

3. The patients are receiving the standard regimen of 0.2g cyclophosphamide given as
intravenous injection once every two days.

Exclusion Criteria:

1. Pregnant women, women in breast-feeding period and the women who refuse to take
contraception measures during treatment.

2. Patients with poor compliance.

3. Patients who are also diagnosed of cancer or who are receiving cyclophosphamide in
treatment of cancer, or other anti-cancer therapy.