Lupus Erythematosus, SystemicNCT01060410
Exploration of Genotype Based Personalized Prescription of Cyclophosphamide in Systemic Lupus Erythematosus Treatment
An observational study of Lupus Erythematosus, Systemic and Adverse Effects, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Lupus Erythematosus, Systemic, Adverse Effects
- What is being tested?
- Polymorphism Analysis, Cyclophosphamide and Pharmacokinetic analysis
- Type of treatment
- Injection or infusion
- How many people
- 222 participants
- Where
- 1 siteChina
- Study dates
- May 2010to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: SLE patients receiving treatment with cyclophosphamide
Who may be able to join
- The patients must have been diagnosed as SLE according to the American College of Rheumatology (ACR) criteria published in 1997.
- 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.
- The patients are receiving the standard regimen of 0.2g cyclophosphamide given as intravenous injection once every two days.
Who cannot join
- Pregnant women, women in breast-feeding period and the women who refuse to take contraception measures during treatment.
- Patients with poor compliance.
- Patients who are also diagnosed of cancer or who are receiving cyclophosphamide in treatment of cancer, or other anti-cancer therapy.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University
Guangzhou, Guangdong, 510080
About this study
Official title: Exploration of Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus Treatment
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.
Read the detailed description
Cyclophosphamide is a widely applied agent in treatment of systemic lupus erythematosus. As an alkylating agent, cyclophosphamide is able to induce several side effects, including thinned hair, loss of appetite, nausea, vomiting, infection, myelosuppression, etc. However, the remarkable variability of the reactions to the drug -- the incidence of side effect or the outcome of the treatment -- has been observed among patients. Cyclophosphamide is a pro-drug, which require some enzymes in the liver to transform it into an active chemical to arouse alkylating function. And then it undergoes a series of detoxification steps catalyzed by the specific metabolic enzymes. This study is designed to explore the genetic variation among individuals in the key processes of the activation and elimination of cyclophosphamide in order to find out whether these genetic factors are associated to the side effects or efficacy. The further understanding into the factors concerning on the drug might imply possible solution to minimize the incidence of side effects in patients of systemic lupus erythematosus.
- Conditions
- Lupus Erythematosus, Systemic, Adverse Effects
- Being tested
- Polymorphism Analysis, Cyclophosphamide, Pharmacokinetic analysis
- Keywords
- Myelosuppression, Infection, Nausea
- Medical subject headings
- Lupus Erythematosus, Systemic, Infections, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polymorphism AnalysisGenetic
Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the bio-activation and elimination of cyclophosphamide
CyclophosphamideDrug
intravenous injection, 0.2g, once every two days
Pharmacokinetic analysisOther
laboratory analysis of concentration of cyclophosphamide and 4-OH-cyclophosphamide in plasma
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide,low dose,continuous | Not described Receives: Genetic: Polymorphism Analysis; Drug: Cyclophosphamide; Other: Pharmacokinetic analysis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Principal investigator, Wenying Shu, Sun Yat-sen University
- Investigators
- Min Huang, PhD., Study chair, Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, ChinaXueding Wang, PhD., Study director, Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, ChinaWenying Shu, PhD., Principal investigator, Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, ChinaXiuyan Yang, MD., Study director, Department of Rheumatology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, ChinaLiuqin Liang, MD., Principal investigator, Department of Rheumatology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01060410
- Sponsor's protocol ID
- 30873124-CTX2008
- Status last verified
- Jun 2012
- First submitted
- 1 Feb 2010
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Genetic Polymorphisms Related to Individual Variations of Side Effects of Cyclophosphamide in Systemic Lupus Erythematosus Treatment
- ClinicalTrials.gov ID
- NCT01060410
- Acronym / sponsor ID
- 30873124-CTX2008
- Conditions
- Lupus Erythematosus, Systemic, Adverse Effects
- Keywords
- Myelosuppression, Infection, Nausea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University
- Study start
- May 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 2 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cyclophosphamide is a widely applied agent in treatment of systemic lupus erythematosus. As an alkylating agent, cyclophosphamide is able to induce several side effects, including thinned hair, loss of appetite, nausea, vomiting, infection, myelosuppression, etc. However, the remarkable variability of the reactions to the drug -- the incidence of side effect or the outcome of the treatment -- has been observed among patients. Cyclophosphamide is a pro-drug, which require some enzymes in the liver to transform it into an active chemical to arouse alkylating function. And then it undergoes a series of detoxification steps catalyzed by the specific metabolic enzymes. This study is designed to explore the genetic variation among individuals in the key processes of the activation and elimination of cyclophosphamide in order to find out whether these genetic factors are associated to the side effects or efficacy. The further understanding into the factors concerning on the drug might imply possible solution to minimize the incidence of side effects in patients of systemic lupus erythematosus.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide,low dose,continuous | – | Genetic: Polymorphism Analysis, Drug: Cyclophosphamide, Other: Pharmacokinetic analysis |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- SLE patients receiving treatment with cyclophosphamide
Key inclusion criteria (3 listed)
- The patients must have been diagnosed as SLE according to the American College of Rheumatology (ACR) criteria published in 1997.
- 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.
- The patients are receiving the standard regimen of 0.2g cyclophosphamide given as intravenous injection once every two days.
Key exclusion criteria (3 listed)
- Pregnant women, women in breast-feeding period and the women who refuse to take contraception measures during treatment.
- Patients with poor compliance.
- Patients who are also diagnosed of cancer or who are receiving cyclophosphamide in treatment of cancer, or other anti-cancer therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polymorphism AnalysisAnalysis of genetic polymorphisms of the drug metabolic enzymes involving in the bio-activation and elimination of cyclophosphamide | Genetic | Cyclophosphamide,low dose,continuous |
| Cyclophosphamideintravenous injection, 0.2g, once every two days | Drug | Cyclophosphamide,low dose,continuous |
| Pharmacokinetic analysislaboratory analysis of concentration of cyclophosphamide and 4-OH-cyclophosphamide in plasma | Other | Cyclophosphamide,low dose,continuous |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Systemic lupus erythematosusLink provided by the sponsor.
- Help Me Understand GeneticsLink provided by the sponsor.
- Cytochrome P450Link provided by the sponsor.
- CyclophosphamideLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Huang, PhD. study chair
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
Xueding Wang, PhD. study director
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
Wenying Shu, PhD. principal investigator
Institute of Clinical Pharmacology, School of Pharmaceutical Sciences, Sun Yat-sen University, Guangzhou, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lupus Erythematosus, Systemic and Adverse Effects, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.