- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01274208
Examining the Immune Response in Patients With Gaucher Disease and Hepatitis C
Enhanced HCV Nonstructural Protein 3 (NS3) -Specific T Cell Proliferation,Interferon γ (IFNγ) and Interleukin-10 (IL-10) Secreting Clones, and Peripheral Blood Natural Killers T Cells ( NKT Cells) in Patients With Type I Gaucher Disease Infected With HCV : An Advantage in Anti Hepatitis Immunity?
Study objectives:
- Investigate the anti-HCV response in patients with Gaucher disease(GD)
- Define the potential role of high levels of Glucocerebroside in the immune system
Study hypothesis:
High levels of Glucocerebroside can be used as a tool in the antiviral treatment of hepatitis C by potentiating the immune response of natural killer T cells and dendritic cells
연구 개요
상세 설명
Gaucher disease is the most common glycolipid storage disorder, caused by reduced activity of the lysosomal enzyme glucocerebrosidase, which leads to the accumulation of the substrate, glucocerebroside (GC), in the cells of the reticulo-endothelial system.
One of the hallmarks of GD is its great phenotypic heterogeneity with variable presentations and symptoms, beginning with a lethal variant of infants dying at or near birth with hydrops fetalis and ichthyoids at one extreme and totally asymptomatic individuals without any physical or laboratory abnormalities at the other extreme.
This autosomal recessive disease is pan-ethnic, but it is especially prevalent among Ashkenazi Jews. From over 300 different mutations reported in the glucocerebrosidase gene, five account for 98% of the disease-producing alleles. Of these mutations, N370S (or 1226G) occurs in 1 out of 17 Ashkenazi individuals, leading to a disease frequency of 1:850 in this ethnic group.
The high prevalence of more than a single mutation among Ashkenazi Jews and the existence of two additional rare inherited lysosomal glycolipid storage diseases, Tay Sachs and Nieman Pick, at a higher prevalence within the same ethnic group is believed to be caused by selective advantage.
Available genetic data are consistent with a founder effect(4) whereas the nature of such an advantage has not been identified.
The aim of this study was to investigate the anti-HCV immune response in patients with GD in an attempt to define the potential role of high levels of GC in the immune system and antiviral immunity.
Study importance:
The host metabolic background exerts a profound effect on antiviral immunity, which may influence the clinical course of chronic HCV infection.
The accumulation of GC in patients with GD may provide a selective evolutionary advantage to these patients.
Glucocerebroside was recently tested in human trials and shown to be effective in altering NKT- dependent metabolic pathways, insulin resistance, and associated liver injury.
The present study examine the capability of Glucocerebroside to be be used as a tool in the antiviral treatment of hepatitis C by potentiating the immune response of natural killer T cells and dendritic cells.
Statistical Analysis:
Data are presented as the mean ± standard deviation (SD). The Kruskal Wallis non-parametric ANOVA test was used to identify differences between the study groups.
The student t-test and non-parametric Mann-Whitney test were used to compare quantitative variables between the study groups as appropriate; P <0.05 was considered to be significant.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Bernardo Melamud, Dr.
- 전화번호: 972-508685845
- 이메일: dr.bernardo@gmail.com
연구 연락처 백업
- 이름: Ari Zimran, Prof.
- 전화번호: 972-2-65555143
- 이메일: azimran@gmail.com
연구 장소
-
-
-
Jerusalem, 이스라엘
- 모병
- Hadassah Medical Center
-
연락하다:
- Yaron Ilan, Prof.
- 전화번호: 972 2 6778231
- 이메일: ilan@hadassah.org.il
-
부수사관:
- Yaron Ilan, Prof.
-
Jerusalem, 이스라엘, 91120
- 모병
- Shaare Zedek , Medical Center
-
연락하다:
- Melamud
- 이메일: dr.bernardo@gmail.com
-
연락하다:
- zimran, Prof.
- 이메일: azimran@gmail.com
-
수석 연구원:
- Bernardo Melamud, Dr.
-
부수사관:
- Ari Zimran, Prof.
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Patients with Gaucher disease
- Patients with hepatitis C without Gaucher disease
- Individuals or patients without Gaucher disease and hepatitis C
- Individuals or patients who signed an approval for the research
- Men and women 18< years of age , pregnant women
Exclusion Criteria:
- Inabillity to give an approval for the research
- Acute liver disease that can alter the lab results , such as: Rt. congestive heart failure
severe infection ,inflammation, medication such as : Statins , Isoniazid ,
Amiodarone
- Patients who received treatment for hepatitis C such as: Interferon ,
Pegylated interferon , Ribavirin
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
---|
Gaucher Disease with Hepatitis C
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Gaucher patients' immune system provide enhanced immunity against hepatitis c virus
기간: 6 months
|
6 months
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
the role Glucocerebroside level have by enhanced immunity in patients with Gaucher disease
기간: 30 days
|
30 days
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Bernardo Melamud, Dr., Gaucher Clinic , Shaare zedek Hospital
간행물 및 유용한 링크
일반 간행물
- Elstein D, Abrahamov A, Hadas-Halpern I, Zimran A. Gaucher's disease. Lancet. 2001 Jul 28;358(9278):324-7. doi: 10.1016/S0140-6736(01)05490-3. No abstract available.
- Butters TD. Gaucher disease. Curr Opin Chem Biol. 2007 Aug;11(4):412-8. doi: 10.1016/j.cbpa.2007.05.035. Epub 2007 Jul 23.
- Beutler E. Gaucher disease: multiple lessons from a single gene disorder. Acta Paediatr Suppl. 2006 Apr;95(451):103-9. doi: 10.1080/08035320600619039.
- Slatkin M. A population-genetic test of founder effects and implications for Ashkenazi Jewish diseases. Am J Hum Genet. 2004 Aug;75(2):282-93. doi: 10.1086/423146. Epub 2004 Jun 18.
- Beutler E. Gaucher disease as a paradigm of current issues regarding single gene mutations of humans. Proc Natl Acad Sci U S A. 1993 Jun 15;90(12):5384-90. doi: 10.1073/pnas.90.12.5384.
- Zigmond E LG, Pappo O, Zangen S, Levy Sklair M, Hemed N, Rabbani E, Itamar R, Ilan Y, Margalit M. Treatment of non-alcoholic steatohepatitis by B-glucosylceramide: A phase I/II clinical study. Hepatology 2006;44 .180A, .
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- SZMC- 89/10
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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