Clinical trial NCT02864199: 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
Official title: Non-Randomized, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Peginterferon Alfa-2a and Copegus Combination Therapy After Single and Multiple Doses in Patients With Chronic Hepatitis C and Moderate Renal Impairment, Severe Renal Impairment, or End-Stage Renal Disease Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-08-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cmax of peginterferon alfa-2a
timeFrame: 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
measure: CL/F of ribavirin
timeFrame: 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
measure: Percentage of participants with undetectable HCV RNA level
timeFrame: Week 12
measure: Cmax of ribavirin
timeFrame: 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
measure: AUC of ribavirin
timeFrame: 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
measure: AUC of peginterferon alfa-2a
timeFrame: 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
measure: Clearance (CL/F) of peginterferon alfa-2a
timeFrame: 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
Secondary outcomes:
measure: Time of maximum concentration (Tmax) of peginterferon alfa-2a
timeFrame: 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
measure: Tmax of ribavirin
timeFrame: 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
measure: Plasma concentration of ribavirin
timeFrame: 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
measure: Percentage of participants with adverse events (AEs)
timeFrame: From Baseline to Week 12 (or up to Week 48 if treatment continued)
measure: Percentage of participants with a dose modification or premature withdrawal for safety reasons
timeFrame: From Baseline to Week 12 (or up to Week 48 if treatment continued)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Kansas City
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Kansas City
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: New York
country: United States
state: New York
city: Syracuse
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Pittsburgh
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
city: Galveston
country: United States
state: Texas
city: Sao Paulo
country: Brazil
city: Marseille
country: France
city: Christchurch
country: New Zealand
city: Riccarton, Christchurch
country: New Zealand
city: Huddinge
country: Sweden
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: