Mayo Clinic Tests New Drug to Prevent Hepatitis C Recurrence after Liver Transplant

Thursday, March 08, 2007

ROCHESTER, Minn. — The Mayo Clinic Transplant Center is studying whether Hepatitis C Immune Globulin (Human), an investigational drug candidate known as Civacir, prevents the recurrence of hepatitis C-related liver disease in liver transplant patients.

Mayo Clinic sites in Arizona, Florida and Minnesota are looking for adults to participate in this study. Eligible participants must have hepatitis C and need a liver transplant. Individuals who have liver cancer may participate.

Hepatitis C is a liver infection caused by the hepatitis C virus (HCV). Each year approximately 6,000 liver transplants are performed in the United States, and more than 2,000 of those are due to HCV. There are no approved or effective treatments for HCV-positive liver transplant patients or patients who receive HCV-positive livers.

"The clinical need for hepatitis C prevention in liver transplant patients is great," says Michael Charlton, M.D., medical director of the liver transplant program at Mayo Clinic's campus in Rochester, Minn. "HCV recurrence for liver transplant patients is nearly 100 percent. Five years after transplantation, one-third of re-infected patients either pass away, get re-transplanted or experience cirrhosis from HCV."

Civacir is a human-pooled antibody product created from blood and serum donated by individuals who have HCV antibodies. The idea for this potential therapy for hepatitis C came from an unexpected result of a similar human antibody drug for hepatitis B, known as HBIG.

"Prior to the discovery of hepatitis C in 1988, HBIG unknowingly included hepatitis C antibodies," says Dr. Charlton. "A retrospective study of approximately 200 patients who received HBIG found that in addition to preventing hepatitis B, it also prevented hepatitis C in about half of the cases."

The Mayo Clinic study will test whether Civacir can prevent HCV recurrence after liver transplant.

More than 400 patients receive liver transplants at Mayo Clinic's three sites each year. Mayo Clinic is the most experienced liver transplant center in the nation, with some of the highest survival rates in the world.

For more information on eligibility requirements and the screening process for this study, contact Kristin Eggebraaten, Mayo Clinic liver transplant referral coordinator at 1-888-227-7501 (toll-free).

Civacir is a product of NABI Biopharmaceuticals and Kedrion S.p.A.

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