NCT02438917

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2017

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

May 6, 2015

Last Update Submit

April 10, 2017

Conditions

Hepatitis C

Keywords

Hepatitis CCirrhosisBiomarkersFibrosis

Outcome Measures

Primary Outcomes (1)

  • Change in serum protein

    Change in the ratio of transforming growth factor binding protein 1 (TGFB1) at 36 months as compared to baseline

    baseline and 36 months

Secondary Outcomes (3)

  • Change in the FibroScan score

    baseline and 36 months

  • Change in the ELF score

    baseline and 36 months

  • Change in the FIB-4 score

    baseline and 36 months

Study Arms (1)

Hepatitis C

Patients who are about to begin HCV treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with the hepatitis C virus (HCV) who are about to begin HCV treatment.

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Incarcerated Person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, Urine, Saliva

MeSH Terms

Conditions

Hepatitis CFibrosis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Andrea D Branch, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2015

First Posted

May 8, 2015

Study Start

June 1, 2015

Primary Completion

March 3, 2017

Study Completion

March 3, 2017

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

US(1)