Chronic Hepatitis B Virus InfectionPhase 1PKNCT01708889
Pharmacokinetic Study of BMS-914143 in Participants With Normal Renal Function and Mild, Moderate, Severe and End-stage Renal Dysfunction
A Phase 1 study testing BMS-914143 (Peginterferon Lambda-1a) in people with Chronic Hepatitis B Virus Infection and Chronic Hepatitis C Virus Infection, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B Virus Infection, Chronic Hepatitis C Virus Infection
- What is being tested?
- BMS-914143 (Peginterferon Lambda-1a)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2012to Feb 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal renal function or mild, moderate, severe or end-stage renal dysfunction
Who cannot join
- History of uncontrolled or unstable cardiovascular, respiratory, gastrointestinal, hepatic, endocrine, hematopoietic, psychiatric or neurological conditions within 6 months of Lambda administration
- History of chronic liver disease including cirrhosis, hepatitis B virus (HBV), hepatitis C virus (HCV), primary biliary cirrhosis, etc
- History of central nervous system or neuro-psychiatric disease. Subjects with severe depression and/or other uncontrolled psychiatric conditions should not be enrolled in this study
- History of of suicide attempt within the 5 years preceding BMS-914143 administration
- Inability to tolerate subcutaneous injections
- Donation of >400 mL of blood within 8 weeks or plasma within 4 weeks of planned dosing
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New Orleans Center For Clinical Research - Knoxville
Knoxville, Tennessee, 37920
Clinical Pharmacology Of Miami Inc.
Miami, Florida, 33014-3616
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: An Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-914143 in Subject With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-stage Renal Dysfunction
The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.
Read the detailed description
Primary purpose: Protocol designed to evaluate the effect of renal impairment on pharmacokinetics of BMS-914143
- Being tested
- BMS-914143 (Peginterferon Lambda-1a)
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-914143 (Peginterferon Lambda-1a)Biological
Also called Lambda
| Study group | Role | What they receive |
|---|---|---|
| Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2) | Experimental | 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 Receives: Biological: BMS-914143 (Peginterferon Lambda-1a) |
| Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2) | Experimental | 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 Receives: Biological: BMS-914143 (Peginterferon Lambda-1a) |
| Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2) | Experimental | 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 Receives: Biological: BMS-914143 (Peginterferon Lambda-1a) |
| Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2) | Experimental | 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 Receives: Biological: BMS-914143 (Peginterferon Lambda-1a) |
| Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2) | Experimental | 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) Receives: Biological: BMS-914143 (Peginterferon Lambda-1a) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 18 time points up to Day 29
Secondary outcomes (5)
Time to maximum observed serum concentration (Tmax) using serum levels of Lambda
Measured: 18 time points up to Day 29
Half life (T-HALF) using serum levels of Lambda
Measured: 18 time points up to Day 29
Immunogenicity assessed by serum levels of anti-Lambda antibodies
Measured: 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)
Measured: 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)
Measured: Approximately up to Day 73
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B Virus InfectionStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708889
- Sponsor's protocol ID
- AI452-019
- Acronym
- PK
- Status last verified
- Jun 2013
- First submitted
- 16 Oct 2012
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-914143 in Subject With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-stage Renal Dysfunction
- ClinicalTrials.gov ID
- NCT01708889
- Acronym / sponsor ID
- PK / AI452-019
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effect of renal impairment on pharmacokinetics (PK) of BMS-914143.
Detailed description
Primary purpose: Protocol designed to evaluate the effect of renal impairment on pharmacokinetics of BMS-914143
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2) | Experimental | Biological: BMS-914143 (Peginterferon Lambda-1a)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 |
| Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2) | Experimental | 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 |
| Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2) | Experimental | 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 |
| Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2) | Experimental | 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 |
| Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2) | Experimental | 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal renal function or mild, moderate, severe or end-stage renal dysfunction
Key exclusion criteria (6 listed)
- History of uncontrolled or unstable cardiovascular, respiratory, gastrointestinal, hepatic, endocrine, hematopoietic, psychiatric or neurological conditions within 6 months of Lambda administration
- History of chronic liver disease including cirrhosis, hepatitis B virus (HBV), hepatitis C virus (HCV), primary biliary cirrhosis, etc
- History of central nervous system or neuro-psychiatric disease. Subjects with severe depression and/or other uncontrolled psychiatric conditions should not be enrolled in this study
- History of of suicide attempt within the 5 years preceding BMS-914143 administration
- Inability to tolerate subcutaneous injections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-914143 (Peginterferon Lambda-1a)Also: Lambda | Biological | Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2), Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2), Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2), Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2), Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2) |
Primary outcome
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
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
Related trials for Chronic Hepatitis B Virus Infection
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-914143 (Peginterferon Lambda-1a) in people with Chronic Hepatitis B Virus Infection and Chronic Hepatitis C Virus Infection, run by Bristol-Myers Squibb at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2013.