This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Ursodeoxycholic acid (UDCA) is currently the only approved drug for the treatment of PBC. It has been shown to prolong the time to liver transplant and may prolong survival. UDCA does this by reducing the damaging effects of toxic compounds called bile salts that can build up in the liver when there is damage to the ducts. However, UDCA has no effect on the immune system and thus the immune injury to the bile ducts responsible for the disease. Immunosuppressive medications (drugs that lower the immune system), such as methotrexate and tacrolimus, therefore, have been evaluated in clinical trials as treatment for PBC. Even though such studies have shown these drugs to be safe at the dosages prescribed, their potential long-term side effects are unknown. The purpose of this study is to find out if methotrexate or tacrolimus may cause delayed, previously unrecognized effects, either harmful or beneficial, to patients who participated in clinical trials evaluating these medications in PBC at this institution. Subjects will be seen at3, 6, or 12 month intervals depending upon the severity. This is an observational study.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000065-46
Application #
7717027
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-12-01
Project End
2008-11-30
Budget Start
2007-12-01
Budget End
2008-11-30
Support Year
46
Fiscal Year
2008
Total Cost
$55,748
Indirect Cost
Name
Virginia Commonwealth University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
105300446
City
Richmond
State
VA
Country
United States
Zip Code
23298
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Al Hawaj, M A; Martin, E J; Venitz, J et al. (2013) Monitoring rFVIII prophylaxis dosing using global haemostasis assays. Haemophilia 19:409-14
Noureddin, Mazen; Yates, Katherine P; Vaughn, Ivana A et al. (2013) Clinical and histological determinants of nonalcoholic steatohepatitis and advanced fibrosis in elderly patients. Hepatology 58:1644-54
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