Pegylated Interferon and Ribavirin to Treat Chronic Hepatitis C With and Without Kidney Disease

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will examine the effectiveness of pegylated interferon, or peginterferon (a long-acting form of alpha interferon) plus ribavirin in treating hepatitis C (genotype 1) infection with and without kidney disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

• INCLUSION CRITERIA:

All Patients:

• Age 18 years or above, male or female.

• Presence of HCV RNA (with or without anti-HCV) in serum.

• Genotype 1 HCV as determined by probe specific hybridization (Inno-Lipa assay).

• Evidence of chronic hepatitis on liver biopsy done within the previous 48 months with a necroinflammatory histology activity index of at least 3 (out of a maximum of 18).

• Written informed consent.

Additional inclusion criteria for Groups A, B and D:

• Serum alanine (ALT) or aspartate aminotransferase (AST) above the upper limit of the normal range (ALT 41 greater than IU/L: AST greater than 31 IU/L) on any serum testing during the previous six months.

Additional inclusion criteria for Group C:

• Chronic renal disease with creatinine clearance less than 50 cc/min or serum creatinine greater than 2.0 mg%.

• If on chronic hemodialysis or peritoneal dialysis, stable clinical condition including stable hematocrit.

• If on chronic dialysis, potential candidacy for renal transplantation.

EXCLUSION CRITERIA:

• Previous treatment with alpha interferon.

• If cirrhosis is present, decompensated liver disease, as marked by bilirubin greater than 4 mg%, albumin less than 3.0 gm%, prothrombin time greater than 2 sec prolonged, or history of bleeding esophageal varices, ascites or hepatic encephalopathy.

• Serum ALT or AST levels greater than 1000 U/L (greater than 25 times ULN). Such patients will not be enrolled but may be followed until three determinations are below this level.

• Pregnancy or, in women of child-bearing potential or in spouses of such women, inability to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicide, or birth control pills, or an intrauterine device.

• Significant systemic or major illnesses other than renal failure (in Group C), including congestive heart failure, organ transplantation, serious psychiatric disease or depression, human immunodeficiency virus (HIV) infection, and angina pectoris.

• Pre-existing anemia (hematocrit less than 33%) or known history of hemolytic anemia. In patients in Group C, erythropoetin therapy will be modified to achieve an adequate hematocrit if clinically indicated.

• Other antiviral therapy within the last 6 months.

• Immunosuppressive therapy with either corticosteroids (more than 5 mg of prednisone daily) or major immunosuppressive agents (such as azathioprine or 6-mercaptopurine).

• Evidence of another form of liver disease in addition to viral hepatitis (for example autoimmune liver disease, Wilson's disease, alcoholic liver disease, hemochromatosis, alpha-1-antitrypsin deficiency).

• Evidence of coronary artery disease or cerebral vascular disease, including abnormalities on exercise stress testing in patients with defined risk factors who will be screened for evidence of underlying coronary artery disease.

• Active substance abuse, such as alcohol, inhaled or injection drugs within the previous year.

• Evidence of hepatocellular carcinoma; either alphafetoprotein (AFP) levels greater than 50 ng/ml (normal less than 9 ng/ml) and/or ultrasound (or other imaging study) demonstrating a mass suggestive of liver cancer.

• Clinical gout.

• Active, serious autoimmune disease such as lupus erythematosis, ulcerative colitis, Crohn's disease or rheumatoid arthritis that in the opinion of the investigators might be exacerbated by therapy with alpha interferon.