The National Institute of Diabetes & Digestive & Kidney Diseases

Liver Diseases Databases, Registries and Information

Acute Liver Failure Study Group (ALFSG)

The ALFSG is collecting biosamples and information on the natural history, causes and outcomes of Acute Liver Failure (ALF) in the United States. In addition to the database, a clinical trial was conducted to test whether the drug N-acetylcysteine improves outcome (survival) for patients with ALF not caused by acetaminophen overdose has recently been published. Results can be found at:http://www.ncbi.nlm.nih.gov/pubmed/19524577?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract
Additional information can be obtained at: www8.utsouthwestern.edu/utsw/cda/dept25203/files/89624.html 

For more information, contact Dr. Averell Sherker, DDN, Senior Scientific Advisor, Viral Hepatitis and Liver Diseases.

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

A collection of statistics about specific digestive diseases, including prevalence, mortality, care delivery and cost.

Drug-Induced Liver Injury Network (DILIN)

Both a prospective and retrospective database containing cases of drug-induced liver disease, DILIN is funded by a cooperative agreement and includes five clinical centers and a central data coordinating center. One of the goals of DILIN is to establish a database of well-characterized cases of drug-induced liver injury along with serum, DNA, and tissue samples that will facilitate research on the mechanisms of hepatic injury due to drugs. Cases of liver injury due to herbal medications are also included. DILIN will develop standardized definitions of drug-induced liver disease and standardization of scoring systems for causality. Additional information can be obtained at: https://dilin.dcri.duke.edu

For more information, contact Dr. Jose Serrano, DDN, Director, Liver and Biliary Program and Pancreas Program.

The Centers are housed at outstanding academic institutions, staffed by experts in state-of-the-art technology. Researchers can ship mice to one of the four Centers and obtain on a fee-for-service basis a range of complex exams used to characterize mouse metabolism, blood composition including hormones, energy balance, eating and exercise, organ function and morphology, physiology and histology. Many tests are done in living animals and are designed to elucidate subtle to complex traits that would define models of metabolic disease.

For more information, contact Dr. Maren Laughlin, DEM, Senior Advisor for Integrative Metabolism.

The National Gene Vector Laboratories (NGVL) are composed of an interactive group of academic production and pharm/tox laboratories whose primary goal is to provide eligible investigators with clinical grade vectors for phase I/II gene therapy clinical trials and to provide support for relevant pharmacology/toxicology studies leading up to clinical gene transfer protocols. If the application is approved, clinical grade material will be produced at no cost to the investigator.

For more information, contact Dr. Catherine McKeon, DEM, Senior Advisor for Genetic Research in Diabetes, Endocrinology and Metabolic Diseases.

The Nuclear Receptor Resource (NRR) Project is a collection of individual databases on members of the steroid and thyroid hormone receptor superfamily. Although the databases are located on different servers and are managed individually, they each form a node of the NRR. The NRR itself integrates the separate databases and allows an interactive forum for the dissemination of information about the superfamily.

For more information, contact Dr. Ronald Margolis, DEM, Senior Advisor, Molecular Endocrinology.

Commensurate with this directive, NURSA's goals can be distilled into two broad aims: (i) to execute research strategies designed to rapidly and efficiently elucidate those facets of orphan nuclear receptor biology we deem most critical to its understanding; and (ii) to facilitate the generation of hypotheses, design of experiments and communication of results by scientists active in this field. We anticipate that this initiative will provide a valuable service to the nuclear receptor community by developing a web-accessible bioinformatics resource, in which current and emerging data will be organized into more accessible and "user-mineable" forms.

For more information, contact Dr. Ronald Margolis, DEM, Senior Advisor, Molecular Endocrinology.

The U.S. Organ Procurement and Transplantation Network (OPTN) maintains a registry of human tissues in order to ensure the success and efficiency of the U.S. organ transplant system.

For more information, contact Dr. Thomas Eggerman, DEM, Director, Islet Transplantation Clinical Trials Program.

Pediatric Acute Liver Failure (PALF) Study 

This multi-center, multi-national collaborative group of pediatric clinical liver centers is aimed at identifying, characterizing, and developing management strategies for infants, children, and adolescents who present with acute liver failure (ALF). In addition to a database of pediatric patients with ALF, a clinical trial is being conducted to test whether the drug N-acetylcysteine (NAC) improves outcome (survival) for patients with ALF not caused by acetaminophen overdose. Additional information can be obtained at: www.palfstudy.org 

For more information, contact Dr. Averell Sherker, DDN, Senior Scientific Advisor, Viral Hepatitis and Liver Diseases.

Liver Diseases Multicenter Clinical Research

Acute Liver Failure Study Group (ALFSG)

The ALFSG is collecting biosamples and information on the natural history, causes and outcomes of Acute Liver Failure (ALF) in the United States. In addition to the database, a clinical trial was conducted to test whether the drug N-acetylcysteine improves outcome (survival) for patients with ALF not caused by acetaminophen overdose has recently been published. Results can be found at:http://www.ncbi.nlm.nih.gov/pubmed/19524577?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVAbstract
Additional information can be obtained at: www8.utsouthwestern.edu/utsw/cda/dept25203/files/89624.html 

For more information, contact Dr. Averell Sherker, DDN, Senior Scientific Advisor, Viral Hepatitis and Liver Diseases.

The Clinical Trials in Organ Transplantation (CTOT) project is a cooperative research program sponsored by NIAID, NIDDK & NHLBI. This consortium is conducting clinical and associated mechanistic studies to facilitate improved outcomes for abdominal (kidney & liver) and thoracic (heart & lung) transplant recipients; short and long-term graft and patient survival.

For more information, contact Dr. Catherine Meyers, KUH, Director, Inflammatory Kidney Diseases Program.

Drug-Induced Liver Injury Network (DILIN)

Both a prospective and retrospective database containing cases of drug-induced liver disease, DILIN is funded by a cooperative agreement and includes five clinical centers and a central data coordinating center. One of the goals of DILIN is to establish a database of well-characterized cases of drug-induced liver injury along with serum, DNA, and tissue samples that will facilitate research on the mechanisms of hepatic injury due to drugs. Cases of liver injury due to herbal medications are also included. DILIN will develop standardized definitions of drug-induced liver disease and standardization of scoring systems for causality. Additional information can be obtained at: https://dilin.dcri.duke.edu

For more information, contact Dr. Jose Serrano, DDN, Director, Liver and Biliary Program and Pancreas Program.

Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) Trial

This prospective, randomized, controlled clinical trial studied long-term therapy with peginterferon in patients with chronic hepatitis C. Patient enrollment began in 2000 and was completed in 2003 at 10 clinical centers, which were supported by a data coordinating center, virological testing center, and central sample repository. Patients with chronic hepatitis C and advanced fibrosis or cirrhosis on liver biopsy who failed to respond to a previous course of interferon alfa were enrolled in this study. Patients were initially treated with a 24-week course of peginterferon alfa-2a and ribavirin. Patients who remained hepatitis C virus RNA positive were then randomized to receive maintenance, low-dose peginterferon or to be followed on no treatment. Liver biopsies were done before enrollment and after 2 and 4 years of treatment or follow-up. The endpoints were development of cirrhosis, hepatic decompensation, hepatocellular carcinoma, death, or liver transplantation. 1050 patients were randomized and followed through the 4 year randomized phase of the trial and as long as 4 years off treatment.  Serum samples collected at multiple time points, DNA and liver tissue are available for scientific investigation. Additional information can be obtained at: www.haltctrial.org 

For more information, contact Dr. Jay Everhart, DDN, Director, Epidemiology and Data Systems Branch.

This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplanation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected. Enrollment is now complete.

Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN)

The NASH CRN researches the nature and underlying cause of NASH and conducts clinical studies on prevention and treatment. Approximately 1,500 pediatric and adult participants throughout the United States and Canada with nonalcoholic fatty liver disease (NAFLD) have enrolled into a database which began in late 2003. The NASH CRN has recently reopened the database to enroll additional pediatric and adult participants with NAFLD. Serum, liver tissue, and genomic DNA samples are being collected and stored in the NIDDK repository for ongoing as well as future studies. A three-arm randomized, placebo-controlled clinical trial of pioglitazone versus vitamin E completed enrollment in 2009. In addition to this adult trial, a similar trial in pediatric NASH patients randomized 180 children to receive treatment with vitamin E, metformin, or placebo. Additional information can be obtained at: www.nashcrn.com

For more information, contact  Dr. Ed Doo, DDN, Director, Liver Diseases Program.

Pediatric Acute Liver Failure (PALF) Study 

This multi-center, multi-national collaborative group of pediatric clinical liver centers is aimed at identifying, characterizing, and developing management strategies for infants, children, and adolescents who present with acute liver failure (ALF). In addition to a database of pediatric patients with ALF, a clinical trial is being conducted to test whether the drug N-acetylcysteine (NAC) improves outcome (survival) for patients with ALF not caused by acetaminophen overdose. Additional information can be obtained at: www.palfstudy.org

For more information, contact Dr. Averell Sherker, DDN, Senior Scientific Advisor, Viral Hepatitis and Liver Diseases.

Peginterferon and Ribavirin for Pediatric Patients with Chronic Hepatitis C (Peds-C)

This prospective, randomized controlled trial was completed in 2008 and studied peginterferon therapy, with or without ribavirin, in children with chronic hepatitis C. Approximately 120 children were randomly assigned to receive peginterferon alfa-2a alone or peginterferon with ribavirin for 48 weeks. Samples of blood, genomic DNA, and liver tissue are stored in the NIDDK repositories. A long-term follow up study of the clinical trial participants is underway. Additional information can be obtained at: www.pedsc.org

Liver Diseases Basic Research Networks

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

Childhood Liver Disease Research and Education Network (ChiLDREN)

The overall goal of ChiLDREN is to establish a database of clinical information and serum and tissue samples from children across the United States and Canada with Biliary Atresia, Idiopathic Neonatal Hepatitis, Cystic Fibrosis Liver Disease, Alagille Syndrome, Alpha-1 Antitrypsin Deficiency, Bile Acid Synthesis Defects, Mitochondrial Hepatopathies, and Progressive Familial Intrahepatic Cholestasis in order to facilitate research and to perform clinical, epidemiological, and therapeutic trials in these important pediatric liver diseases. Three NIDDK-funded consortia, Biliary Atresia Research Consortium (BARC), Cholestatic Liver Disease Consortium (CLiC), and the Cystic Fibrosis Liver Disease (CFLD) Network were consolidated to form ChiLDREN. Additional information can be obtained at: www.childrennetwork.org

For more information, contact Dr. Averell Sherker, DDN, Senior Scientific Advisor, Viral Hepatitis and Liver Diseases.

Drug-Induced Liver Injury Network (DILIN)

Both a prospective and retrospective database containing cases of drug-induced liver disease, DILIN is funded by a cooperative agreement and includes five clinical centers and a central data coordinating center. One of the goals of DILIN is to establish a database of well-characterized cases of drug-induced liver injury along with serum, DNA, and tissue samples that will facilitate research on the mechanisms of hepatic injury due to drugs. Cases of liver injury due to herbal medications are also included. DILIN will develop standardized definitions of drug-induced liver disease and standardization of scoring systems for causality. Additional information can be obtained at: https://dilin.dcri.duke.edu

For more information, contact Dr. Jose Serrano, DDN, Director, Liver and Biliary Program and Pancreas Program.

Hepatitis B Research Network (HBRN)

The Hepatitis B Research Network (HBRN) brings together clinical centers with expertise in caring for patients with chronic hepatitis B virus (HBV) infection. An estimated 2 billion people worldwide have been infected with HBV and about 400 million persons are living with chronic HBV infection. Of those with childhood-acquired chronic HBV infection, it is estimated that 25% will later succumb to liver-related complications of cancer and cirrhosis if left untreated. The prevalence of HBV infection is uneven throughout the world, with significant burdens in Asia and the Pacific Islands, sub-Saharan Africa, the Amazon Basin, and Eastern Europe. The goal of the Network is to conduct research on chronic hepatitis B, in order to better understand the physiological effects of the disease and develop effective treatment strategies with the currently available therapies. Additional information can be obtained at: www.hepbnet.org 

For more information, contact Dr. Edward Doo, DDN, Director, Liver Diseases Program.

The Centers are housed at outstanding academic institutions, staffed by experts in state-of-the-art technology. Researchers can ship mice to one of the four Centers and obtain on a fee-for-service basis a range of complex exams used to characterize mouse metabolism, blood composition including hormones, energy balance, eating and exercise, organ function and morphology, physiology and histology. Many tests are done in living animals and are designed to elucidate subtle to complex traits that would define models of metabolic disease.

For more information, contact Dr. Maren Laughlin, DEM, Senior Advisor for Integrative Metabolism.

NMRI is a communication network of current and potential biomedical research investigators and technical personnel from traditionally under-served communities: African American, Hispanic American, American Indian, Alaskan Native, Native Hawaiian, and other Pacific Islanders. The major objective of the network is to encourage and facilitate participation of members of underrepresented racial and ethnic minority groups in the conduct of biomedical research in the fields of diabetes, endocrinology, metabolism, digestive diseases, nutrition, kidney, urologic and hematologic diseases. A second objective is to encourage and enhance the potential of the underrepresented minority investigators in choosing a biomedical research career in these fields. An important component of this network is promotion of two-way communications between network members and the NIDDK.

For more information, contact Ms. Winnie Martinez, Program Analyst, Office of Minority Health Research Coordination.

Commensurate with this directive, NURSA's goals can be distilled into two broad aims: (i) to execute research strategies designed to rapidly and efficiently elucidate those facets of orphan nuclear receptor biology we deem most critical to its understanding; and (ii) to facilitate the generation of hypotheses, design of experiments and communication of results by scientists active in this field. We anticipate that this initiative will provide a valuable service to the nuclear receptor community by developing a web-accessible bioinformatics resource, in which current and emerging data will be organized into more accessible and "user-mineable" forms.

For more information, contact Dr. Ronald Margolis, DEM, Senior Advisor, Molecular Endocrinology.

Pediatric Acute Liver Failure (PALF) Study 

This multi-center, multi-national collaborative group of pediatric clinical liver centers is aimed at identifying, characterizing, and developing management strategies for infants, children, and adolescents who present with acute liver failure (ALF). In addition to a database of pediatric patients with ALF, a clinical trial is being conducted to test whether the drug N-acetylcysteine (NAC) improves outcome (survival) for patients with ALF not caused by acetaminophen overdose. Additional information can be obtained at: www.palfstudy.org 

For more information, contact Dr. Averell Sherker, DDN, Senior Scientific Advisor, Viral Hepatitis and Liver Diseases.

Liver Diseases Reagents

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

The National Gene Vector Laboratories (NGVL) are composed of an interactive group of academic production and pharm/tox laboratories whose primary goal is to provide eligible investigators with clinical grade vectors for phase I/II gene therapy clinical trials and to provide support for relevant pharmacology/toxicology studies leading up to clinical gene transfer protocols. If the application is approved, clinical grade material will be produced at no cost to the investigator.

For more information, contact Dr. Catherine McKeon, DEM, Senior Advisor for Genetic Research in Diabetes, Endocrinology and Metabolic Diseases.

Liver Diseases Services

A centralized facility established to provide genotyping and statistical genetics services for investigators seeking to identify genes that contribute to human disease. CIDR concentrates primarily on multifactorial hereditary disease although linage analysis of single gene disorders can also be accommodated.

For more information, contact Dr. Catherine McKeon, DEM, Senior Advisor for Genetic Research in Diabetes, Endocrinology and Metabolic Diseases.

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

The Centers are housed at outstanding academic institutions, staffed by experts in state-of-the-art technology. Researchers can ship mice to one of the four Centers and obtain on a fee-for-service basis a range of complex exams used to characterize mouse metabolism, blood composition including hormones, energy balance, eating and exercise, organ function and morphology, physiology and histology. Many tests are done in living animals and are designed to elucidate subtle to complex traits that would define models of metabolic disease.

For more information, contact Dr. Maren Laughlin, DEM, Senior Advisor for Integrative Metabolism.

NIH RAID provides a variety of contract services researchers need to bring promising potential therapeutics to trial.

Liver Diseases Standardization Programs

Liver Diseases Tissues, Cells, Animals

On July 1, 2003, The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) established Central NIDDK Repositories for biosamples and data collected in clinical studies. The purpose of the Central Repositories is to expand the usefulness of these studies by providing access to the biosamples and data to a wider research community beyond the end of the study.

For more information, contact Dr. Rebekah Rasooly, Deputy Director of the Division of Kidney, Urologic, and Hematologic Diseases.

The Liver Tissue Procurement and Distribution System (LTPADS) is a National Institutes of Health (NIH) service contract to provide human liver from regional centers for distribution to scientific investigators throughout the United States. These USA regional centers have active liver transplant programs with human subjects' approval to provide portions of the resected pathologic liver for which the transplant is performed. Frozen or fresh tissue is available from subcontractors for the usual forms of childhood and adult cirrhosis, fulminate liver failure, chronic rejection, and certain inborn errors of metabolism. “Normal” liver specimens may be requested, however, the supply is appropriately very limited and completion of large proposal requests is unlikely. A new service is now offered to provide isolated hepatocytes only to NIH investigators from "normal" human liver.

For more information, contact Dr. Jose Serrano, DDN, Director, Liver and Biliary Program and Pancreas Program.

The Centers are housed at outstanding academic institutions, staffed by experts in state-of-the-art technology. Researchers can ship mice to one of the four Centers and obtain on a fee-for-service basis a range of complex exams used to characterize mouse metabolism, blood composition including hormones, energy balance, eating and exercise, organ function and morphology, physiology and histology. Many tests are done in living animals and are designed to elucidate subtle to complex traits that would define models of metabolic disease.

For more information, contact Dr. Maren Laughlin, DEM, Senior Advisor for Integrative Metabolism.

The goal of the MMRRC program is to enhance the availability of and help ensure the quality of genetically modified mice for biomedical research of human and animal biology and disease.

For more information, contact Dr. Kristin Abraham, DEM, Director, Cell Signaling and Diabetes Centers Program.

Liver Diseases Useful Tools