National Institute of Diabetes, Digestive & Kidney Diseases (NIDDK), Acquisition Management Branch, Natcher Building, 45 Center Dr., MSC 6600, Room 6AN32, Bethesda, Maryland 20892-6600

A -- HEPATITIS C CLINICAL TRIAL -- CLINICAL CENTERS SOL NIH-NIDDK-98-4 DUE 032398 POC Robert T. Coonley, Contracting Officer, phone: 301-594-8837, fax: 301-480-8261, e-mail: CoonleyR@ep.niddk.nih.gov The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Division of Digestive Diseases and Nutrition (DDDN), has a requirement for Long-Term Therapies for the Prevention of Cirrhosis and Hepatocellular Carcinoma in Chronic Hepatitis C (Hepatitis C Clinical Trial). The Trial will include six (6) to eight (8) Clinical Centers (CCs), a Data Coordinating Center (DCC) with biostatistical expertise and with input from a hepatologist, and a Virology Laboratory (VL). This solicitation is for the Clinical Centers for the Hepatitis C Clinical Trial. This project is aimed at developing practical, safe and effective means of preventing the progression of liver disease in patients with chronic hepatitis C virus (HCV) infection. Proposals will be solicited that include a clinical trial protocol using long-term alpha interferon therapy in chronic hepatitis C patients with cirrhosis of the liver and hepatocellular carcinoma. Between 400 and 600 patients with chronic hepatitis C who have failed to respond to therapy with alpha interferon (with or without ribavirin) and who have significant fibrosis on liver biopsy will be enrolled in a study of the efficacy and safety of continuous therapy (for as long as four years) with alpha interferon. The objective of the Trial is to evaluate whether continuous therapy with long-term low doses of alpha interferon can slow the progression of liver disease, preventing cirrhosis or preventing worsening of cirrhosis, decompensation, development of hepatocellular carcinoma (HCC) and death from liver disease. The Trial will also evaluate the natural history of hepatitis C and the facts that predict or correlate with disease progression. The major focus will be to evaluate whether interferon, despite not leading to eradication of HCV, can suppress hepatocellular injury, necrosis and fibrosis. Patients with chronic hepatitis C who have previously been treated with alpha interferon without a sustained virological and biochemical response will be eligible to enter the Trial. The Request for Proposals, RFP No. NIH-NIDDK-98-4, will be issued on or about December 23, 1997 with a closing date of on or about March 23, 1998. Requests for the RFP must be in writing, addressed to the Contracting Officer cited above, and must cite the referenced RFP number. All responsible sources may submit a proposal which will be considered by the agency. The Government is not committed to award contract(s) pursuant to this announcement. (0338)

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