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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Peginterferon alfa-2a will be administered for 12 to 48 weeks. The dose will range from 135 mcg (Group C) to 180 mcg (Groups A, B, and D) once weekly via SC route.
Ribavirin will be administered for 12 to 48 weeks. The total daily dosage will range from 200 mg (Group C) to 1200 mg (Group D), depending upon CrCl and participant-specific factors.
Unnamed facility
Birmingham, Alabama, United States
Unnamed facility
Kansas City, Kansas, United States
Unnamed facility
New Orleans, Louisiana, United States
Unnamed facility
Kansas City, Missouri, United States
Unnamed facility
St Louis, Missouri, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Syracuse, New York, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Portland, Oregon, United States
Unnamed facility
Pittsburgh, Pennsylvania, United States
...and 7 more locations
Cmax of peginterferon alfa-2a
Time frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
CL/F of ribavirin
Time frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Percentage of participants with undetectable HCV RNA level
Time frame: Week 12
Cmax of ribavirin
Time frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
AUC of ribavirin
Time frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
AUC of peginterferon alfa-2a
Time frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Clearance (CL/F) of peginterferon alfa-2a
Time frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Time of maximum concentration (Tmax) of peginterferon alfa-2a
Time frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Tmax of ribavirin
Time frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Plasma concentration of ribavirin
Time frame: Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Percentage of participants with adverse events (AEs)
Time frame: From Baseline to Week 12 (or up to Week 48 if treatment continued)
Percentage of participants with a dose modification or premature withdrawal for safety reasons
Time frame: From Baseline to Week 12 (or up to Week 48 if treatment continued)
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