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

NCT01060410 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 222

Last updated 2012-06-20

No results posted yet for this study

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.

Conditions

  • Lupus Erythematosus, Systemic
  • Adverse Effects

Interventions

GENETIC

Polymorphism Analysis

Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the bio-activation and elimination of cyclophosphamide

DRUG

Cyclophosphamide

intravenous injection, 0.2g, once every two days

OTHER

Pharmacokinetic analysis

laboratory analysis of concentration of cyclophosphamide and 4-OH-cyclophosphamide in plasma

Sponsors & Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Min Huang, PhD. · Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

  • Xueding Wang, PhD. · Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

  • Wenying Shu, PhD. · Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China

  • Xiuyan Yang, MD. · Department of Rheumatology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

  • Liuqin Liang, MD. · Department of Rheumatology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China

Eligibility

Min Age
12 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01060410 on ClinicalTrials.gov