Lipoprotein and Apolipoproteins With Metabolic Liver Diseases

April 17, 2018 updated by: Chun-Hsiang Wang

Theranostic Translation Applications Against Viral, Metabolic Liver Diseases and Hepatic Oncogenesis: Lipoprotein and Apolipoproteins at a Crossroad

Theranostic translation applications against viral, metabolic liver diseases and hepatic oncogenesis: lipoprotein and apolipoproteins at a crossroad

Study Overview

Detailed Description

An intimate link between microbial infections, metabolic changes and oncogenesis has been drawn attentions increasingly, indicating a crossroad leading to pathogenesis and disease progression. Globally the burden of hepatitis B and C virus infections is 450 and 185 millions, respectively and chronic hepatitis disease causes a high risk of liver cirrhosis, hepatocellular carcinoma and metabolic disorders

Study Type

Observational

Enrollment (Anticipated)

440

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Tainan, Taiwan, 701
        • Chun-Hsiang Wang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

An intimate link between microbial infections, metabolic changes and oncogenesis has been drawn attentions increasingly, indicating a crossroad leading to pathogenesis and disease progression. Globally the burden of hepatitis B and C virus infections is 450 and 185 millions, respectively and chronic hepatitis disease causes a high risk of liver cirrhosis, hepatocellular carcinoma and metabolic disorders

Description

Inclusion Criteria:

  1. above 20 years
  2. nonalcoholic fatty liver disease
  3. Non-Alcoholic Steatohepatitis

Exclusion Criteria:

1. alcohonic hepatitis 2. Autoimmune liver disease 3. HIV postive

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
proposed cross-section study
  1. 100 subjects with NAFLD/NASH and negative anti-HCV Ab
  2. 50 subjects with HCC and negative anti-HCV Ab
  3. 50 subjects with HCC and positive for genotype-1 HCV
  4. 50 controls with all negative for NAFLD/NASH but positive for genotype-1 HCV
  5. 50 controls with all negative for NAFL, NASH and HCV
To find out the role of lipoprotein and apolipoproteins (apos) in pathogenic hepatic diseases
proposed longitudinal study
  1. 50 NAFLD/NASH patients and positive for genotype-1 HCV with SVR
  2. 10 NAFLD/NASH patients and positive for genotype-1 HCV without SVR
  3. 10 HCC patients and positive for genotype-1 HCV with SVR
  4. 10 HCC patients and positive for genotype-1 HCV without SVR
  5. 50 chronic hepatitis C but not NAFLD patients with SVR
  6. 10 chronic hepatitis C but not NAFLD patients without SVR
To find out the role of lipoprotein and apolipoproteins (apos) in pathogenic hepatic diseases

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Theranostic Translation Applications Against Viral, Metabolic Liver Diseases and Hepatic Oncogenesis: Lipoprotein and Apolipoproteins at a Crossroad
Time Frame: 2years
Study the interplay between hepatitis C virus (HCV) and lipid metabolism(the HCV infection affects host lipid homeostasis, regarding transportation, synthesis, and catabolism.)
2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2017

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

July 3, 2017

First Submitted That Met QC Criteria

July 13, 2017

First Posted (Actual)

July 18, 2017

Study Record Updates

Last Update Posted (Actual)

April 19, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Disorders of Lipoprotein Metabolism and Other Lipidaemias

Clinical Trials on lipoprotein and apolipoproteins

3
Subscribe