Clinical Trials

The Liver, Biliary, and Pancreatic Center and the Division of Gastroenterology of the University of Massachusetts Medical Center offer suitable subjects the opportunity to participate in several research studies. At present, the following protocols are open to enrollment for suitable patients.

Initial Treatment - Chronic Hepatitis C - Interferon Alone vs. Iron Reduction Followed by Interferon.

This six-month randomized, controlled study is open to patients who have never received Interferon therapy.

To be eligible to participate, patients must:

  • be at least 18 years old;
  • have a clinical diagnosis of chronic hepatitis C with anti-HCV antibodies in blood ;
  • have had no previous treatment with interferon;
  • have no evidence of cirrhosis or bridging fibrosis;
  • have at least 3 abnormal serum ALT levels (> 1.3 x ULN) during the 12 months prior to enrollment;
  • have platelet count > 70,000/mL, WBC > 3,000/mL, and ANC > 1,000/mL.

NOTE: We can check lab tests and perform liver biopsy here, if needed.

Retreatment--Chronic Hepatitis C: Interferon alpha and ribavirin.

This trial is open to patients who have previously been treated with interferon-alpha but either failed to show a complete response to initial standard treatment or who have relapsed.

To be eligible to participate, patients must:

  • be at least 18 years old;
  • have compensated liver disease with the following minimum hematologic and biochemical criteria:
  • hemoglobin > 13 g/dL for males; > 12 g/dL for females;
  • WBC > 3000/ mL;
  • Neutrophil count > 1,500/ mL;
  • Platelets > 100,000/ mL;
  • Direct bilirubin < 0.3 mg/dL, or within 20% ULN for local laboratory;
  • Indirect bilirubin < 0.8 mg/dL or within 20% ULN;
  • Anti-HIV negative;
  • HBsAg negative;
  • ANA < 1:160.

Active Crohn's Disease. A Placebo-Controlled Study: Budesonide Controlled Ileal Release Capsules.

To be eligible to participate, patients must:

  • be at least 18 years old;
  • have established diagnosis of Crohn's disease (mild-moderate) limited to the ileium and/or ascending colon;
  • be suitable for treatment of Crohn's disease with oral corticosteroids as single therapy;
  • be suitable for discontinuation of all current therapies except cholestyramine, sucralfate, loperamide, diphenoxylate, and other opiates;
  • have not had resection of > 100 cm of the ileum or any resection distal to the mid-transverse colon.

Other areas of active research include the following:

Evaluation and Management of Iron Storage Diseases

We have considerable expertise in the evaluation and management of known or possible hemochromatosis, including quantitative measurement of hepatic iron concentrations and development of improved NMR methods for estimating these concentrations non-invasively.


If you desire further information regarding clinical trials of the Liver, Biliary, and Pancreatic Center, please contact Denise Stefancyk, R.N. at 508-856-1982 or the main office of the Division of Gastroenterology at 508-856-3068 (phone) or 508-856-3981 (fax).



Gastroenterology
UMassMedical School
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Worcester, MA 01655

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