A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment

Completed · Phase 4

Conditions studied: Hepatitis C, Chronic

In brief

This study will evaluate the pharmacokinetics (area under the curve \[AUC\], maximum concentration \[Cmax\], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target sample size is 48 individuals.

Key facts

Study ID

NCT02864199

Run by

Hoffmann-La Roche

People needed

63

Starts

2004-02-01

Expected to finish

2007-09-01

Last updated by the study team

2016-08-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 to 65 years of age
• CHC infection as shown on enzyme-linked immunosorbent assay (ELISA) and radioimmunoblot assay (RIBA) or quantifiable hepatitis C virus (HCV) ribonucleic acid (RNA) greater than (>) 2000 copies per milliliter (copies/mL)
• Use of two forms of contraception during study and 6 months after the study in both men and women
• Normal renal function (creatinine clearance [CrCl] >80 milliliters per minute [mL/min]), moderate renal impairment (CrCl 30 to 50 mL/min), severe renal impairment (CrCl less than [<] 30 mL/min), or ESRD requiring hemodialysis
• Patients with ESRD must have been undergoing hemodialysis for at least 2 months

You may not qualify if…

• Women who are pregnant or breastfeeding
• Male partners of women who are pregnant
• Conditions associated with decompensated and/or chronic liver disease
• Human immunodeficiency virus (HIV) infection
• Interferon or ribavirin treatment within the previous 3 months
• Poor hematologic function, including unstable hemoglobin
• Significant comorbidity or severe illness which would make the participant unsuitable for the study
• Acute renal failure

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Kansas City, Kansas, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Syracuse, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Galveston, Texas, United States
• Study site — São Paulo, Brazil
• Study site — Marseille, France
• Study site — Christchurch, New Zealand
• Study site — Riccarton, Christchurch, New Zealand
• Study site — Huddinge, Sweden

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.