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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 February 2015
Main ID:	NCT01060410
Date of registration:	01/02/2010
Prospective Registration:	Yes
Primary sponsor:	Sun Yat-sen University
Public title:	Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus Treatment
Scientific title:	Exploration of Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus Treatment
Date of first enrolment:	May 2010
Target sample size:	222
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT01060410
Study type:	Observational
Study design:	Observational Model: Case-Only, Time Perspective: Prospective
Phase:	N/A

Countries of recruitment
China

Contacts

Name:	Xiuyan Yang, MD.
Address:
Telephone:
Email:
Affiliation:	Department of Rheumatology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

Name:	Liuqin Liang, MD.
Address:
Telephone:
Email:
Affiliation:	Department of Rheumatology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

Name:	Wenying Shu, PhD.
Address:
Telephone:
Email:
Affiliation:	Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

Name:	Min Huang, PhD.
Address:
Telephone:
Email:
Affiliation:	Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

Name:	Xueding Wang, PhD.
Address:
Telephone:
Email:
Affiliation:	Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

Key inclusion & exclusion 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.

Age minimum: 12 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Adverse Effects

Lupus Erythematosus, Systemic

Intervention(s)

Drug: Cyclophosphamide

Genetic: Polymorphism Analysis

Other: Pharmacokinetic analysis

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

30873124-CTX2008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

First Affiliated Hospital, Sun Yat-Sen University

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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