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Hepatitis B VirusPhase 2LIRA-BNCT01204762

Dose Ranging Study of Pegylated Interferon Lambda in Patients With Hepatitis B and Positive for the Hepatitis B e Antigen

A Phase 2 study testing pegIFN, pegIFNα-2a and PegIFN lambda in people with Hepatitis B Virus, run by Bristol-Myers Squibb at 53 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

At least 1 dose of pegIFNλ will be identified which is safe, well tolerated, and efficacious for the treatment of chronic hepatitis B virus infection (CHB) Amendment 7, Part B Sub Study: The primary purpose of this amendment is to obtain preliminary data on the safety of pegylated interferon Lambda (Lambda) when… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis B Virus
What is being tested?
pegIFN, pegIFNα-2a and PegIFN lambda
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
53 sitesin 11 countries
Study dates
Nov 2010to Dec 2013
Phase
Phase 2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Infection with the hepatitis B virus (HBV) and positive for the hepatitis B e antigen
  • Between the ages of 18 and 70
  • Have not been previously treated with an interferon
  • HBV nucleos(t)ide-naive

Who cannot join

  • Not infected with the hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
  • Do not have a serious liver, psychiatric, blood, thyroid, lung, heart or eye disease
  • Able to tolerate oral medication

Trial locations and contacts

53 sites in 11 countries.

53 sites in 11 countries

United States13 sites

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • Atlanta Gastroenterology Associates, Llc

    Atlanta, Georgia, 30308

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Gastro Center Of Maryland

    Colombia, Maryland, 21045

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Medical Procare, Pllc

    Flushing, New York, 11355

  • Office Of Sing Chan Md

    Flushing, New York, 11355

  • Sc Clinical Research, Inc.

    Garden Grove, California, 92844

  • Yale New Haven Hospital

    New Haven, Connecticut, 06520

  • University Of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • University Of California, Davis Medical Center

    Sacramento, California, 95817

  • Research And Education, Inc.

    San Diego, California, 92105

Other trials in United States

Australia7 sites

  • Local Institution

    Camperdown, New South Wales, 2050

  • Local Institution

    Clayton Vic, Victoria, 3168

  • Local Institution

    Fremantle, Western Australia, 6160

  • Local Institution

    Heidelberg Vic, Victoria, 3084

  • Local Institution

    Liverpool, New South Wales, 2170

  • Local Institution

    Melbourne, Victoria, 3004

  • Local Institution

    Westmead Nsw, New South Wales, 2145

Other trials in Australia

South Korea6 sites

  • Local Institution

    Chuncheon, 200-704

  • Local Institution

    Gyeonggi-do, 480-717

  • Local Institution

    Seoul, 120-752

  • Local Institution

    Seoul, 135-710

  • Local Institution

    Seoul, 135-720

  • Local Institution

    Seoul, 138-736

Other trials in South Korea

Taiwan6 sites

  • Local Institution

    Kaohsiung City, 807

  • Local Institution

    Taichung, 404

  • Local Institution

    Tainan, 704

  • Local Institution

    Taipei, 100

  • Local Institution

    Taipei, 114

  • Local Institution

    Taoyuan, 333

Other trials in Taiwan

Germany5 sites

  • Local Institution

    Frankfurt, 60590

  • Local Institution

    Freiburg im Breisgau, 79106

  • Local Institution

    Hamburg, 20246

  • Local Institution

    Hanover, 30625

  • Local Institution

    Tübingen, 72076

Other trials in Germany

Canada4 sites

  • Heritage Medical Research Clinic, University Of Calgary

    Calgary, Alberta, T2N 4Z6

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Toronto Western Hospital University Health Network

    Toronto, Ontario, M5T 2S8

  • Local Institution

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

France4 sites

  • Local Institution

    Clichy, 92118

  • Local Institution

    Nice, 06202

  • Local Institution

    Paris, 75571

  • Local Institution

    Rennes, 35033

Other trials in France

Hong Kong3 sites

  • Local Institution

    Hong Kong, 852

  • Local Institution

    Shatin, 30-32

  • Local Institution

    Tai Po, 852

Other trials in Hong Kong

Italy2 sites

  • Local Institution

    Florence, 50012

  • Local Institution

    Roma, 00161

Other trials in Italy

Singapore2 sites

  • Local Institution

    Singapore, 119228

  • Local Institution

    Singapore, 169608

Other trials in Singapore

Netherlands1 site

  • Local Institution

    Rotterdam, 3015 CE

Other trials in Netherlands

About this study

Official title: Dose-Ranging Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Pegylated Interferon Lambda (BMS-914143) Monotherapy in Interferon-Naive Patients With Chronic Hepatitis B Virus Infection Who Are HBeAg-positive

At least 1 dose of pegIFNλ will be identified which is safe, well tolerated, and efficacious for the treatment of chronic hepatitis B virus infection (CHB)

Amendment 7, Part B Sub Study: The primary purpose of this amendment is to obtain preliminary data on the safety of pegylated interferon Lambda (Lambda) when administered in combination with Entecavir(ETV) to patients with hepatitis E antigen-positive (HBeAg-positive) chronic hepatitis B(CHB) infection employing a sequential therapy approach

Read the detailed description

Part B sub study is Open Label

Being tested
pegIFN, pegIFNα-2a, PegIFN lambda, Entecavir
Medical subject headings
Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pegIFNDrug

    Syringe, Subcutaneous, 180 μg, Once Weekly, 48 weeks

  • pegIFNα-2aDrug

    Also called Pegasys

    Syringe, Subcutaneous 180 μg, Once Weekly, 48 Weeks

  • PegIFN lambdaDrug

    Also called BMS-914143

    Syringe, Subcutaneous, 180 µg, Once weekly, 48 weeks

  • EntecavirDrug

    Also called Baraclude

    Tablet, Oral, 0.5 mg, Once daily, 12 weeks initial monotherapy followed by 48 weeks of combination therapy with PegIFN lambda

Study groups in NCT01204762
Study groupRoleWhat they receive
Part A Arm 1: pegIFN (180 μg)ExperimentalNot described
Receives: Drug: pegIFN
Part A Arm 2: pegIFNα-2aActive comparatorNot described
Receives: Drug: pegIFNα-2a
Part B: pegIFN lambda + EntecavirExperimentalNot described
Receives: Drug: PegIFN lambda; Drug: Entecavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Proportion of subjects who achieve Hepatitis B e antigen (HBeAg) seroconversion

    Measured: 24 weeks post-dosing (Week 72)

  2. Part A: Number and percent of subjects with serious adverse events (SAEs) and discontinuations due to adverse events

    Measured: Week 24

  3. Part A: Number and percent of subjects with serious adverse events (SAEs) and discontinuations due to adverse events

    Measured: 24 weeks post-dosing (Week 72)

  4. Part B: Safety and tolerability of Lambda/ETV regimen as measured by the frequency of SAEs and discontinuations due to AEs

    Measured: Up to 84 Weeks

Secondary outcomes (27)

  1. Part A: Proportion of subjects who achieve an hepatitis B virus Deoxyribonucleic acid levels (HBV DNA) < 50 IU/mL (approximately 300 copies/mL) using the Roche COBAS® TaqMan - High Pure System (HPS) assay

    Measured: Weeks 24, 48, 72, 96, 120, 144, 168 and 192

  2. Part A: Mean change from baseline in log10 HBV DNA levels over time (Proportion of subjects with Alanine amino transferase (ALT) normalization (≤ 1 x upper limit of normal (ULN))

    Measured: Baseline (Day 1), Weeks 24, 48, 72, 96, 120, 144, 168 and 192

  3. Part A: Proportion of subjects with ALT normalization (≤ 1 x ULN)

    Measured: Weeks 24, 48, 72, 96, 120, 144, 168 and 192

  4. Part A: Hepatitis E antigen (HBeAg) loss

    Measured: Weeks 24, 48, 72, 96, 120, 144, 168 and 192

  5. Part A: HBeAg seroconversion

    Measured: Weeks 24, 48, 96, 120, 144, 168 and 192

  6. Part A: Mean change from baseline in log10 quantitative HBeAg levels over time

    Measured: Baseline (Day 1), Weeks 24, 48, 96, 120, 144, 168 and 192

  7. Part A: Number and percent of subjects with adverse events (AEs) or laboratory abnormalities

    Measured: Up to Week 24

  8. Part A: Number and percent of subjects with adverse events (AEs) or laboratory abnormalities

    Measured: Up to Week 72

  9. Part A: Pharmacokinetic (PK) parameter Maximum observed concentration (Cmax) of Pegylated interferon lambda (pegIFNλ) will be derived from serum concentration versus time data

    Measured: Day 1 (including intense PK), Weeks 2, 4, 12 (including intense PK), 16, 24, 40, 48

  10. Part A: Pharmacokinetic (PK) parameter Time of maximum observed concentration (Tmax) of Pegylated interferon lambda (pegIFNλ) will be derived from serum concentration versus time data

    Measured: Day 1 (including intense PK), Weeks 2, 4, 12 (including intense PK), 16, 24, 40, 48

  11. Part A: Pharmacokinetic (PK) parameter Trough serum concentration pre-dose (C0) of Pegylated interferon lambda (pegIFNλ) will be derived from serum concentration versus time data

    Measured: Day 1 (including intense PK), Weeks 2, 4, 12 (including intense PK), 16, 24, 40, 48

  12. Part A: PK parameter serum concentration 168 hours post observed dose [Cmin] (C0 will be used as an estimate of Cmin if sample is not collected) of pegIFNλ will be derived from serum concentration versus time data

    Measured: Day 1 (including intense PK), Weeks 2, 4, 12 (including intense PK), 16, 24, 40, 48

  13. Part A: PK parameter Area under the concentration-time curve in 1 dosing interval from time 0 to 168 hours post observed dose [AUC(TAU)] of pegIFNλ will be derived from serum concentration versus time data

    Measured: Day 1 (including intense PK), Weeks 2, 4, 12 (including intense PK), 16, 24, 40, 48

  14. Part A: PK parameter Accumulation index (AI) ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (only conducted if data warrant) of pegIFNλ will be derived from serum concentration versus time data

    Measured: Day 1 (including intense PK), Weeks 2, 4, 12 (including intense PK), 16, 24, 40, 48

  15. Part B: HBeAg seroconversion rate at 24 weeks off treatment

    Measured: Week 84

  16. Part B: Antiviral activity of Lambda/ETV regimen, as determined by the proportion of subjects who achieve an HBV DNA < 50 IU/mL (approximately 300 copies/mL) using the Roche COBAS® TaqMan - HPS assay

    Measured: Weeks 4, 8, 12, 24, 36, 60, and 84

  17. Part B: Mean change from baseline in HBV DNA over time in subjects treated with Lambda/ETV

    Measured: Weeks 4, 8, 12, 24, 36, 60, and 84

  18. Part B: HBeAg loss and seroconversion in subjects treated with Lambda/ETV regimen

    Measured: Weeks 12, 24, 36, 60 and 84

  19. Part B: HBeAg levels over time in subjects treated with Lambda/ETV regimen

    Measured: Weeks 4, 8, 12, 24, 36, 60, and 84

  20. Part B: biochemical response rates in subjects treated with Lambda/ETV regimen

    Measured: Weeks 4, 8, 12, 24, 36, 60, and 84

  21. Part B: Pharmacokinetic (PK) parameter Maximum observed concentration (Cmax) of Lambda/ETV regimen will be derived from serum concentration versus time data

    Measured: Baseline (Day 1), Weeks 4, 12, 16, 24, 52, 60

  22. Part B: Pharmacokinetic (PK) parameter Time of maximum observed concentration (Tmax) of Lambda/ETV regimen will be derived from serum concentration versus time data

    Measured: Baseline (Day 1), Weeks 4, 12, 16, 24, 52, 60

  23. Part B: Pharmacokinetic (PK) parameter Trough serum concentration pre-dose (C0) of Lambda/ETV regimen will be derived from serum concentration versus time data

    Measured: Baseline (Day 1), Weeks 4, 12, 16, 24, 52, 60

  24. Part B: PK parameter Area under the concentration-time curve in 1 dosing interval from time 0 to 168 hours post observed dose [AUC(TAU)] of Lambda/ETV regimen will be derived from serum concentration versus time data

    Measured: Baseline (Day 1), Weeks 4, 12, 16, 24, 52, 60

  25. Part B: PK parameter serum concentration 168 hours post observed dose [Cmin] (C0 will be used as an estimate of Cmin if sample is not collected) of Lambda/ETV regimen will be derived from serum concentration versus time data

    Measured: Baseline (Day 1), Weeks 4, 12, 16, 24, 52, 60

  26. Part B: PK parameter Accumulation index (AI) ratio of AUC(TAU) at steady-state to AUC(TAU) after the first dose (only conducted if data warrant) of Lambda/ETV regimen will be derived from serum concentration versus time data

    Measured: Baseline (Day 1), Weeks 4, 12, 16, 24, 52, 60

  27. Part B: Rate of resistance to ETV during treatment with the Lambda/ETV regimen

    Measured: Up to Week 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2010 (estimated)
  2. Study startNov 2010
  3. Primary completionDec 2013
  4. Study completionDec 2013

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01204762
Sponsor's protocol ID
AI452-005
Other IDs
2010-020387-38
Acronym
LIRA-B
Status last verified
Sep 2015
First submitted
16 Sep 2010
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Phillips S, Mistry S, Riva A, Cooksley H, Hadzhiolova-Lebeau T, Plavova S, Katzarov K, Simonova M, Zeuzem S, Woffendin C, Chen PJ, Peng CY, Chang TT, Lueth S, De Knegt R, Choi MS, Wedemeyer H, Dao M, Kim CW, Chu HC, Wind-Rotolo M, Williams R, Cooney E, Chokshi S. Peg-Interferon Lambda Treatment Induces Robust Innate and Adaptive Immunity in Chronic Hepatitis B Patients. Front Immunol. 2017 May 29;8:621. doi: 10.3389/fimmu.2017.00621. eCollection 2017.

    PubMed 28611778

  • Chan HLY, Ahn SH, Chang TT, Peng CY, Wong D, Coffin CS, Lim SG, Chen PJ, Janssen HLA, Marcellin P, Serfaty L, Zeuzem S, Cohen D, Critelli L, Xu D, Wind-Rotolo M, Cooney E; LIRA-B Study Team. Peginterferon lambda for the treatment of HBeAg-positive chronic hepatitis B: A randomized phase 2b study (LIRA-B). J Hepatol. 2016 May;64(5):1011-1019. doi: 10.1016/j.jhep.2015.12.018. Epub 2015 Dec 29.

    PubMed 26739688

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing pegIFN, pegIFNα-2a and PegIFN lambda in people with Hepatitis B Virus, run by Bristol-Myers Squibb at 53 sites in 11 countries.

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 4 inclusion and 3 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 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Australia, South Korea, Taiwan, Germany and 6 more countries. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Part A: Proportion of subjects who achieve Hepatitis B e antigen (HBeAg) seroconversion (time frame: 24 weeks post-dosing (Week 72)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01204762, which also lists 2 linked publications.

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 9 Oct 2015.

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