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Trial record 12 of 32 for:    Interleukin-10

Examining the Immune Response in Patients With Gaucher Disease and Hepatitis C

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ClinicalTrials.gov Identifier: NCT01274208
Recruitment Status : Unknown
Verified November 2014 by Ari Zimran, Shaare Zedek Medical Center.
Recruitment status was:  Recruiting
First Posted : January 11, 2011
Last Update Posted : November 19, 2014
Sponsor:
Information provided by (Responsible Party):
Ari Zimran, Shaare Zedek Medical Center

Tracking Information
First Submitted Date January 10, 2011
First Posted Date January 11, 2011
Last Update Posted Date November 19, 2014
Study Start Date January 2011
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 18, 2014)
Gaucher patients' immune system provide enhanced immunity against hepatitis c virus [ Time Frame: 6 months ]
Original Primary Outcome Measures
 (submitted: January 10, 2011)
The anti-HCV or HBV immune response in patients with Gaucher Disease [ Time Frame: 30 days ]
the immune response will be measured by:
  1. Enhanced HCV NS3-specific T cell proliferation
  2. IFNγ and IL-10 secreting clones by ELISPOT assay
  3. Peripheral blood NKT cells(CD3+,CD56+)by FACS analysis
  4. Measurement of serum IL-2, IL-6, IL-10, and TGFβ levels infected with HCV or HBV
Change History Complete list of historical versions of study NCT01274208 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 10, 2011)
the role Glucocerebroside level have by enhanced immunity in patients with Gaucher disease [ Time Frame: 30 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Examining the Immune Response in Patients With Gaucher Disease and Hepatitis C
Official Title 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?
Brief Summary

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

Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with Gaucher Disease were recruited from the Sha'are Zedek Gaucher disease clinic, a national referral center for the disease.
Condition
  • Gaucher Disease
  • Hepatitis C
Intervention Not Provided
Study Groups/Cohorts Gaucher Disease with Hepatitis C
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 10, 2011)
80
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2016
Estimated Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

-

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01274208
Other Study ID Numbers SZMC- 89/10
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ari Zimran, Shaare Zedek Medical Center
Study Sponsor Shaare Zedek Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Bernardo Melamud, Dr. Gaucher Clinic , Shaare zedek Hospital
PRS Account Shaare Zedek Medical Center
Verification Date November 2014