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BMS-914143

Phase 2

Chronic Hepatitis B Virus Infection | Monoclonal antibody | Infectious Disease |Bristol-Myers Squibb Company|Trials Updated: Jun 5, 2013

BMS-914143 development status

Highest phase Phase 2 (NCT01204762)
Phase scored for BMYPhase 1
Registered trials 1 across 1 sponsor since Sep 2010

BMS-914143 target and mechanism

ModalityMonoclonal antibody

Also known as BMS-914143 (Peginterferon Lambda-1a), Pegylated-Interferon-lambda, pegIFNλ, Peginterferon Lambda-1a, PegIFN lambda, Pegylated interferon lambda (pegIFNλ), Pegylated Interferon Lambda-1a

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment43

FDA Designations

No designations recorded

BMS-914143 clinical trials

BMS-914143 · 1 trial · 2 indications

Phase 1 1
NCT01708889Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal DysfunctionChronic Hepatitis B Virus Infection
COMPLETED43 Analytics
PHASE1COMPLETED
Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction
Chronic Hepatitis B Virus InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

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
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
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
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
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
18 time points up to Day 29

Secondary Endpoints

Time to maximum observed serum concentration (Tmax) using serum levels of Lambda
18 time points up to Day 29
Half life (T-HALF) using serum levels of Lambda
18 time points up to Day 29
Immunogenicity assessed by serum levels of anti-Lambda antibodies
5 time points up to Day 43
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2)EXPERIMENTALBMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with normal renal function with eGFR ≥ 80 mL/min/1.73 m2
Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2)EXPERIMENTALBMS-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
Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2)EXPERIMENTALBMS-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
Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2)EXPERIMENTALBMS-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
Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2)EXPERIMENTALBMS-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)

Interventions

NameTypeDescription
BMS-914143 (Peginterferon Lambda-1a)BIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Normal renal function or mild, moderate, severe or end-stage renal dysfunction Exclusion Criteria: * History of uncontrolled or unstable cardiovascular, respiratory, gastrointestinal, hepatic, endocrine, hematopoietic, psychiatric or neurological conditions within 6 months o...

Countries:United States
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Frequently asked questions about BMS-914143

What is BMS-914143?

BMS-914143 is an investigational monoclonal antibody developed by Bristol-Myers Squibb for chronic hepatitis B virus infection. It has completed a single Phase 1 clinical trial. It is also known as peginterferon lambda-1a. The drug has not been approved and remains in clinical development.

What is BMS-914143 used for?

BMS-914143 is being studied for the treatment of chronic hepatitis B virus infection. The one completed trial also enrolled participants with chronic hepatitis C virus infection as a listed condition. It is investigational and has not been approved for any use.

Who makes BMS-914143?

Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker BMY, develops BMS-914143. The company sponsored the Phase 1 pharmacokinetic study of the drug conducted in the United States.

What phase is BMS-914143 in?

BMS-914143 is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The drug is investigational and has not received FDA approval for chronic hepatitis B virus infection or any other indication.

What clinical trials is BMS-914143 in?

BMS-914143 has been studied in one completed Phase 1 trial, NCT01708889. That trial was a pharmacokinetic study of BMS-914143 in participants with normal renal function and mild, moderate, severe, and end-stage renal dysfunction. It enrolled 43 participants in the United States and included healthy volunteers.

Is BMS-914143 the same as peginterferon lambda-1a?

Yes, BMS-914143 is also known as peginterferon lambda-1a. Both names refer to the same investigational Bristol-Myers Squibb compound studied in chronic hepatitis B virus infection. Searches for either name lead to the same drug asset and the same completed Phase 1 trial, NCT01708889.