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Biomarkers of Liver Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02438917
Recruitment Status : Terminated (collaborator Kinemend closed due to finances)
First Posted : May 8, 2015
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
KineMed
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
Chronic liver injury leads to the accumulation of proteins in the liver that form dense scars. Liver scar formation is typically a slow process that leads to major organ damage and loss of function over the course of many years. During scar formation the extracellular matrix in the liver changes. The type and quantity of extracellular collagen and other proteins change during tissue remodeling. Some of these changes can be detected by analyzing factors present in blood. Because of the lengthy time course, changes in the rate of liver scar formation and regression are very difficult measure; however, accurate measurements are needed in order to conduct trials of interventions aimed at preventing scar formation and/or promotion scar regression. Current methods have sub-optimal specificity and selectivity. The long term objective of the study is to identify serum proteins that can be used to accurately estimate rates of liver fibrosis progression and regression. The project focusses on a novel methodology that uses stable isotope labeling with deuterated water, D2O, to tag newly-synthesized proteins. Mass spectroscopy is used to identify individual proteins and to quantify the ratio of labeled protein to total protein. This ratio provides information about the rate of synthesis of the protein of interest. This method will be applied to specimens from patients with hepatitis C virus (HCV) infection who are about to begin HCV treatment. Treatment is known to reduce liver inflammation and collagen content.

Condition or disease
Hepatitis C

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomarkers of Liver Fibrosis
Study Start Date : June 2015
Actual Primary Completion Date : March 3, 2017
Actual Study Completion Date : March 3, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Hepatitis C
Patients who are about to begin HCV treatment



Primary Outcome Measures :
  1. Change in serum protein [ Time Frame: baseline and 36 months ]
    Change in the ratio of transforming growth factor binding protein 1 (TGFB1) at 36 months as compared to baseline


Secondary Outcome Measures :
  1. Change in the FibroScan score [ Time Frame: baseline and 36 months ]
    Change in FibroScan score at 36 months as compared to baseline. FibroScan is performed to assess liver stiffness, an indicator of liver fibrosis.

  2. Change in the ELF score [ Time Frame: baseline and 36 months ]
    Change in ELF score at 36 months as compared to baseline

  3. Change in the FIB-4 score [ Time Frame: baseline and 36 months ]
    Change in the FIB-4 score at 36 months as compared to baseline


Biospecimen Retention:   Samples With DNA
Whole blood, Urine, Saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with the hepatitis C virus (HCV) who are about to begin HCV treatment.
Criteria

Inclusion Criteria:

  • Adult (18 years of age or older)
  • Positive test for HCV RNA
  • Planning to initiate treatment for HCV in the near future
  • Not diagnosed with any additional liver diseases, such as autoimmune hepatitis, hepatitis B, alcoholic liver disease, or HIV
  • Able to travel to Mount Sinai
  • Must understand and speak English
  • Willing to sign informed consent and participate

Exclusion Criteria:

  • Pregnancy
  • Incarcerated Person

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02438917


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
KineMed
Investigators
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Principal Investigator: Andrea D Branch, PhD Icahn School of Medicine at Mount Sinai
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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02438917    
Other Study ID Numbers: GCO 15-0548
First Posted: May 8, 2015    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Keywords provided by Icahn School of Medicine at Mount Sinai:
Hepatitis C
Cirrhosis
Biomarkers
Fibrosis
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Pathologic Processes
Flaviviridae Infections