A Phase 1 interventional study of BMS-914143 (Peginterferon Lambda-1a) in Chronic Hepatitis B Virus Infection and Chronic Hepatitis C Virus Infection, sponsored by Bristol-Myers Squibb. Completed at 3 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-05.
Sponsored by Bristol-Myers Squibb · Phase 1 and Interventional
The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.
Primary purpose: Protocol designed to evaluate the effect of renal impairment on pharmacokinetics of BMS-914143
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 43 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with normal renal function with eGFR ≥ 80 mL/min/1.73 m2
Biological: BMS-914143 (Peginterferon Lambda-1a)
BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with mild renal dysfunction with eGFR 60 to 79 mL/min/1.73 m2
Biological: BMS-914143 (Peginterferon Lambda-1a)
BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with moderate renal dysfunction with eGFR 30 to 59 mL/min/1.73 m2
Biological: BMS-914143 (Peginterferon Lambda-1a)
BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with severe renal dysfunction with eGFR 15 to 29 mL/min/1.73 m2
Biological: BMS-914143 (Peginterferon Lambda-1a)
BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with end-stage renal dysfunction with eGFR \< 15 mL/min/1.73 m2 (on hemodialysis \[HD\] or non-HD)
Biological: BMS-914143 (Peginterferon Lambda-1a)
Also known as: Lambda
Area under the serum concentration-time curve from time 0 extrapolated to infinity [AUC(INF)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
Time frame: 18 time points up to Day 29
Area under the serum concentration-time curve from time 0 to the time of last quantifiable concentration [AUC(0-T)] of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
Time frame: 18 time points up to Day 29
Maximum observed serum concentration (Cmax) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
Time frame: 18 time points up to Day 29
Apparent volume of distribution (Vz/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
Time frame: 18 time points up to Day 29
Total body clearance (CLT/F) of a single 180-μg subcutaneous (SC) dose of Lambda in subjects with normal renal function and subjects with renal dysfunction
Time frame: 18 time points up to Day 29
Time to maximum observed serum concentration (Tmax) using serum levels of Lambda
Time frame: 18 time points up to Day 29
Half life (T-HALF) using serum levels of Lambda
Time frame: 18 time points up to Day 29
Immunogenicity assessed by serum levels of anti-Lambda antibodies
Time frame: 5 time points up to Day 43
Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs)
Time frame: Up to Day 43
Serious adverse events (SAEs) Safety assessed by Vital signs measurements, electrocardiograms (ECGs), clinical laboratory tests, marked laboratory abnormalities, physical measurements, and adverse events (AEs)
Time frame: Approximately up to Day 73
This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.
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