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

NCT00028093 | Completed Phase 4 Results

• 2 other identifiers: 02006502-DK-0065
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis; Cirrhosis; Hepatitis C Virus; Hemolysis; Ribavirin; Alpha Interferon; Peginterferon; Antiviral Agents; Viral Hepatitis; Hemolytic Anemia; Renal Failure; Renal Dialysis; Hepatitis; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Change in Hepatitis C Virus RNA Levels During Phase I

  From day 0 to day 3

Study Arms (2)

Pefinterferon+Ribavirin

EXPERIMENTAL

Patients with chronic hepatitis C virus (HCV) infection genotype 1 peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients \<75 kg and 1200 mg daily for patients \>=75 kg) for 48 weeks

Drug: Peginterferon alfa-2a with Ribavirin

Peginterferon

ACTIVE COMPARATOR

patients with chronic hepatitis C virus (HCV) infection genotype 1 were given peginterferon-alpha-2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.

Drug: Peginterferon alfa-2a

Interventions

Peginterferon alfa-2a with Ribavirin DRUG

Eligible patients were given peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients \<75 kg and 1200 mg daily for patients \>=75 kg) for 48 weeks

Pefinterferon+Ribavirin

Peginterferon alfa-2a DRUG

Eligible patients were given peginterferon-alpha-2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.

Peginterferon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \- 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Liang TJ, Rehermann B, Seeff LB, Hoofnagle JH. Pathogenesis, natural history, treatment, and prevention of hepatitis C. Ann Intern Med. 2000 Feb 15;132(4):296-305. doi: 10.7326/0003-4819-132-4-200002150-00008.

  PMID: 10681285 BACKGROUND

• Major ME, Feinstone SM. The molecular virology of hepatitis C. Hepatology. 1997 Jun;25(6):1527-38. doi: 10.1002/hep.510250637. No abstract available.

  PMID: 9185778 BACKGROUND

• Kiyosawa K, Sodeyama T, Tanaka E, Gibo Y, Yoshizawa K, Nakano Y, Furuta S, Akahane Y, Nishioka K, Purcell RH, et al. Interrelationship of blood transfusion, non-A, non-B hepatitis and hepatocellular carcinoma: analysis by detection of antibody to hepatitis C virus. Hepatology. 1990 Oct;12(4 Pt 1):671-5. doi: 10.1002/hep.1840120409.

  PMID: 2170265 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis, Chronic; Fibrosis; Hepatitis C; Hemolysis; Anemia, Hemolytic; Renal Insufficiency; Hepatitis

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Combination of Pegylated Interferon and Ribavirin as Therapy for Patients With Chronic Hepatitis C W
• Organization: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

hoofnaglej@extra.niddk.nih.gov

3014961333

Study Officials

• Yaron Rotman, MD

  National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Clinical Investigator

Study Record Dates

• First Submitted: December 11, 2001
• First Posted: December 12, 2001
• Study Start: December 1, 2001
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 8, 2013
• Results First Posted: November 8, 2013

Record last verified: 2013-05

Locations

US (1)