Non-Alcoholic Steatohepatitis(NASH)NCT03025074
Blood Collection Biorepository for Liver Disease Research
An observational study of Non-Alcoholic Steatohepatitis(NASH) and Hepatitis C, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Steatohepatitis(NASH), Hepatitis C, Hepatitis B
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2099
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Subjects with NASH, NAFLD, Fibrosis, Cirrhosis, Hepatitis B or C, HIV or any form of Liver Disease.
Who may be able to join
- This protocol is to establish a biobank of blood samples from individuals with or without liver diseases including viral hepatitis, liver cancer, NASH, and negative control samples.
- Children and teenagers will be special populations considered in this protocol.
Who cannot join
- Vulnerable populations such as adults unable to consent, infants, pregnant women or prisoners will not be considered for this research study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University at Buffalo, Buffalo General Medical Center
Buffalo, New York, 14203
Barbara Bauer, BA, 716-888-4825, bmbauer@buffalo.edu
About this study
Official title: Virology, Immunology and Mechanisms of Liver Disease in Patients With Hepatitis C and Other Liver Diseases
The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.
Read the detailed description
The Biorepository at the University at Buffalo has been established to collect biological samples from patients with various types of liver disease. The objectives of this biorepository are to stimulate collaboration between clinicians and researchers, to bolster training of junior investigators and to promote multidisciplinary integration to advance translational medicine and to improve the health of patients all over the country. The purpose of this biorepository is to support investigators and to provide them with high quality specimens to promote their efforts in new discoveries or perfecting treatment of patients with liver diseases caused by Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Human Immunodeficiency Virus (HIV). The goal is to obtain samples that represent patients seen in the clinics of medical centers in Western NY and from some of the rarer diseases encountered in these clinics. The ultimate goal is to develop the biorepository as Western New York's resource for clinically annotated human samples that can be used to conduct research that could lead to significant advances in patient care.
- Conditions
- Non-Alcoholic Steatohepatitis(NASH), Hepatitis C, Hepatitis B, Fibrosis, Cirrhosis, Fatty Liver
- Keywords
- Liver Disease, Obesity, Hepatitis, HIV, Hepatology
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Hepatitis C, Hepatitis B, Fibrosis, Fatty Liver, Pediatric Obesity, Liver Diseases, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of samples collected
Total number of samples collected
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startJul 2013
- Primary completionDec 2099 (estimated)
- Study completionDec 2099 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Steatohepatitis(NASH)Studies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Talal, State University of New York at Buffalo
- Investigators
- Andrew Talal, MD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025074
- Sponsor's protocol ID
- Biobank Blood
- Status last verified
- Oct 2026
- First submitted
- 16 Jan 2017
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The Biorepository was created to provide high quality specimens to future researchers to advance their clinical and translational research.
Publications
Zeremski M, Sylvester C, Talal AH. Response to Commentary on Zeremski et al. (2016): Improvements in HCV-related Knowledge Among Substance Users on Opioid Agonist Therapy After an Educational Intervention. J Addict Med. 2016 Sep-Oct;10(5):364-5. doi: 10.1097/ADM.0000000000000240. No abstract available.
PubMed 27685683Juluru K, Talal AH, Yantiss RK, Spincemaille P, Weidman EK, Giambrone AE, Jalili S, Sourbron SP, Dyke JP. Diagnostic accuracy of intracellular uptake rates calculated using dynamic Gd-EOB-DTPA-enhanced MRI for hepatic fibrosis stage. J Magn Reson Imaging. 2017 Apr;45(4):1177-1185. doi: 10.1002/jmri.25431. Epub 2016 Aug 16.
PubMed 27527820Zeremski M, Dimova RB, Pillardy J, de Jong YP, Jacobson IM, Talal AH. Fibrosis Progression in Patients With Chronic Hepatitis C Virus Infection. J Infect Dis. 2016 Oct 15;214(8):1164-70. doi: 10.1093/infdis/jiw332. Epub 2016 Aug 2.
PubMed 27485356Ocque AJ, Hagler CE, Difrancesco R, Woolwine-Cunningham Y, Bednasz CJ, Morse GD, Talal AH. Development and validation of a UPLC-MS/MS method for the simultaneous determination of paritaprevir and ritonavir in rat liver. Bioanalysis. 2016 Jul;8(13):1353-63. doi: 10.4155/bio-2016-0040. Epub 2016 Jun 9.
PubMed 27277877Zeremski M, Zavala R, Dimova RB, Chen Y, Kritz S, Sylvester C, Brown LS Jr, Talal AH. Improvements in HCV-related Knowledge Among Substance Users on Opioid Agonist Therapy After an Educational Intervention. J Addict Med. 2016 Mar-Apr;10(2):104-9. doi: 10.1097/ADM.0000000000000196.
PubMed 26881485Bednasz CJ, Sawyer JR, Martinez A, Rose PG, Sithole SS, Hamilton HR, Kaufman FS, Venuto CS, Ma Q, Talal A, Morse GD. Recent advances in management of the HIV/HCV coinfected patient. Future Virol. 2015;10(8):981-997. doi: 10.2217/fvl.15.64.
PubMed 26877758Cloherty G, Talal A, Coller K, Steinhart C, Hackett J Jr, Dawson G, Rockstroh J, Feld J. Role of Serologic and Molecular Diagnostic Assays in Identification and Management of Hepatitis C Virus Infection. J Clin Microbiol. 2016 Feb;54(2):265-73. doi: 10.1128/JCM.02407-15. Epub 2015 Dec 9.
PubMed 26659219Zeremski M, Dimova RB, Benjamin S, Penney MS, Botfield MC, Talal AH. Intrahepatic and Peripheral CXCL10 Expression in Hepatitis C Virus-Infected Patients Treated With Telaprevir, Pegylated Interferon, and Ribavirin. J Infect Dis. 2015 Jun 1;211(11):1795-9. doi: 10.1093/infdis/jiu807. Epub 2014 Dec 15.
PubMed 25512630
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virology, Immunology and Mechanisms of Liver Disease in Patients With Hepatitis C and Other Liver Diseases
- ClinicalTrials.gov ID
- NCT03025074
- Acronym / sponsor ID
- Biobank Blood
- Conditions
- Non-Alcoholic Steatohepatitis(NASH), Hepatitis C, Hepatitis B, Fibrosis, Cirrhosis, Fatty Liver
- Keywords
- Liver Disease, Obesity, Hepatitis, HIV, Hepatology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2099 (estimated)
- Study completion
- Dec 2099 (estimated)
- First posted
- 19 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.
Detailed description
The Biorepository at the University at Buffalo has been established to collect biological samples from patients with various types of liver disease. The objectives of this biorepository are to stimulate collaboration between clinicians and researchers, to bolster training of junior investigators and to promote multidisciplinary integration to advance translational medicine and to improve the health of patients all over the country. The purpose of this biorepository is to support investigators and to provide them with high quality specimens to promote their efforts in new discoveries or perfecting treatment of patients with liver diseases caused by Non-Alcoholic Fatty Liver Disease (NAFLD), Non-Alcoholic Steatohepatitis (NASH), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), and Human Immunodeficiency Virus (HIV). The goal is to obtain samples that represent patients seen in the clinics of medical centers in Western NY and from some of the rarer diseases encountered in these clinics. The ultimate goal is to develop the biorepository as Western New York's resource for clinically annotated human samples that can be used to conduct research that could lead to significant advances in patient care.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with NASH, NAFLD, Fibrosis, Cirrhosis, Hepatitis B or C, HIV or any form of Liver Disease.
Key inclusion criteria (2 listed)
- This protocol is to establish a biobank of blood samples from individuals with or without liver diseases including viral hepatitis, liver cancer, NASH, and negative control samples.
- Children and teenagers will be special populations considered in this protocol.
Key exclusion criteria (1 listed)
- Vulnerable populations such as adults unable to consent, infants, pregnant women or prisoners will not be considered for this research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of samples collected
Time frame: 52 weeks
Total number of samples collected
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Background: PubMed 27685683Zeremski M, Sylvester C, Talal AH. Response to Commentary on Zeremski et al. (2016): Improvements in HCV-related Knowledge Among Substance Users on Opioid Agonist Therapy After an Educational Intervention. J Addict Med. 2016 Sep-Oct;10(5):364-5. doi: 10.1097/ADM.0000000000000240. No abstract available.
- Background: PubMed 27527820Juluru K, Talal AH, Yantiss RK, Spincemaille P, Weidman EK, Giambrone AE, Jalili S, Sourbron SP, Dyke JP. Diagnostic accuracy of intracellular uptake rates calculated using dynamic Gd-EOB-DTPA-enhanced MRI for hepatic fibrosis stage. J Magn Reson Imaging. 2017 Apr;45(4):1177-1185. doi: 10.1002/jmri.25431. Epub 2016 Aug 16.
- Background: PubMed 27485356Zeremski M, Dimova RB, Pillardy J, de Jong YP, Jacobson IM, Talal AH. Fibrosis Progression in Patients With Chronic Hepatitis C Virus Infection. J Infect Dis. 2016 Oct 15;214(8):1164-70. doi: 10.1093/infdis/jiw332. Epub 2016 Aug 2.
- Background: PubMed 27277877Ocque AJ, Hagler CE, Difrancesco R, Woolwine-Cunningham Y, Bednasz CJ, Morse GD, Talal AH. Development and validation of a UPLC-MS/MS method for the simultaneous determination of paritaprevir and ritonavir in rat liver. Bioanalysis. 2016 Jul;8(13):1353-63. doi: 10.4155/bio-2016-0040. Epub 2016 Jun 9.
- Background: PubMed 26881485Zeremski M, Zavala R, Dimova RB, Chen Y, Kritz S, Sylvester C, Brown LS Jr, Talal AH. Improvements in HCV-related Knowledge Among Substance Users on Opioid Agonist Therapy After an Educational Intervention. J Addict Med. 2016 Mar-Apr;10(2):104-9. doi: 10.1097/ADM.0000000000000196.
- Background: PubMed 26877758Bednasz CJ, Sawyer JR, Martinez A, Rose PG, Sithole SS, Hamilton HR, Kaufman FS, Venuto CS, Ma Q, Talal A, Morse GD. Recent advances in management of the HIV/HCV coinfected patient. Future Virol. 2015;10(8):981-997. doi: 10.2217/fvl.15.64.
- Background: PubMed 26659219Cloherty G, Talal A, Coller K, Steinhart C, Hackett J Jr, Dawson G, Rockstroh J, Feld J. Role of Serologic and Molecular Diagnostic Assays in Identification and Management of Hepatitis C Virus Infection. J Clin Microbiol. 2016 Feb;54(2):265-73. doi: 10.1128/JCM.02407-15. Epub 2015 Dec 9.
- Background: PubMed 25512630Zeremski M, Dimova RB, Benjamin S, Penney MS, Botfield MC, Talal AH. Intrahepatic and Peripheral CXCL10 Expression in Hepatitis C Virus-Infected Patients Treated With Telaprevir, Pegylated Interferon, and Ribavirin. J Infect Dis. 2015 Jun 1;211(11):1795-9. doi: 10.1093/infdis/jiu807. Epub 2014 Dec 15.
- Individual participant dataSharing planned: Yes. The Biorepository was created to provide high quality specimens to future researchers to advance their clinical and translational research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Talal, MD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Alcoholic Steatohepatitis(NASH) and Hepatitis C, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Bauer, BA (716-888-4825, bmbauer@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of samples collected (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03025074, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.