Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus Treatment
NCT ID: NCT01060410
Last Updated: 2012-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
222 participants
OBSERVATIONAL
2010-05-31
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Cyclophosphamide,low dose,continuous
Polymorphism Analysis
Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the bio-activation and elimination of cyclophosphamide
Cyclophosphamide
intravenous injection, 0.2g, once every two days
Pharmacokinetic analysis
laboratory analysis of concentration of cyclophosphamide and 4-OH-cyclophosphamide in plasma
Interventions
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Polymorphism Analysis
Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the bio-activation and elimination of cyclophosphamide
Cyclophosphamide
intravenous injection, 0.2g, once every two days
Pharmacokinetic analysis
laboratory analysis of concentration of cyclophosphamide and 4-OH-cyclophosphamide in plasma
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
80 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Sun Yat-sen University
OTHER
Responsible Party
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Wenying Shu
Ph.D.
Principal Investigators
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Min Huang, PhD.
Role: STUDY_CHAIR
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
Xueding Wang, PhD.
Role: STUDY_DIRECTOR
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
Wenying Shu, PhD.
Role: PRINCIPAL_INVESTIGATOR
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
Xiuyan Yang, MD.
Role: STUDY_DIRECTOR
Department of Rheumatology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
Liuqin Liang, MD.
Role: PRINCIPAL_INVESTIGATOR
Department of Rheumatology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
Locations
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Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Related Links
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Systemic lupus erythematosus
Help Me Understand Genetics
Cytochrome P450
Cyclophosphamide
Understanding Drug Therapy and Managing Side Effects
Other Identifiers
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30873124-CTX2008
Identifier Type: -
Identifier Source: org_study_id
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