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Hepatitis CPhase 2D-LITENCT01309932

Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin

A Phase 2 study testing Pegylated Interferon Lambda (pegIFNλ), BMS-790052 (NS5A Inhibitor) and Ribavirin (RBV) in people with Hepatitis C, run by Bristol-Myers Squibb at 40 sites in 9 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

The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatitis C
What is being tested?
Pegylated Interferon Lambda (pegIFNλ), BMS-790052 (NS5A Inhibitor) and Ribavirin (RBV)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
165 participants
Where
40 sitesin 9 countries
Study dates
Mar 2011to Sep 2014
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

  • Chronic Hepatitis C, Genotype 1
  • HCV RNA >100,000 IU/mL at screening;
  • Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg);
  • Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%

Who cannot join

  • Any evidence of liver disease other than HCV;
  • Co-infection with HIV;
  • Diagnosed or suspected hepatocellular carcinoma;
  • Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin

Trial locations and contacts

40 sites in 9 countries.

40 sites in 9 countries

United States13 sites

  • University Of Colorado Denver And Hospital

    Aurora, Colorado, 80045

  • Carolinas Medical Center

    Charlotte, North Carolina, 28203

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Metropolitan Research

    Fairfax, Virginia, 22031

  • St. Luke'S Episcopal Hospital - Baylor College Of Medicine

    Houston, Texas, 77030

  • Johns Hopkins University

    Lutherville, Maryland, 21093

  • Bristol-Myers Squibb/David E. Bernstein, Md

    Manhasset, New York, 11030

  • Yale University School Of Medicine

    New Haven, Connecticut, 06510

  • Desert Medical Group Inc.

    Palm Springs, California, 92262

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • Texas Liver Institute

    San Antonio, Texas, 78215

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Carolinas Center For Liver Disease

    Statesville, North Carolina, 28677

Other trials in United States

Japan7 sites

  • Local Institution

    Hiroshima, Hiroshima, 7348511

  • Local Institution

    Iruma-gun, Saitama, 3500495

  • Local Institution

    Kawasaki-shi, Kanagawa, 2138587

  • Local Institution

    Minato-ku, Tokyo, 105-0001

  • Local Institution

    Musashino-shi, Tokyo, 180-0023

  • Local Institution

    Osaka, Osaka, 5458586

  • Local Institution

    Sapporo, Hokkaido, 060-0033

Other trials in Japan

France6 sites

  • Local Institution

    Clichy, 92118

  • Local Institution

    Créteil, 94000

  • Local Institution

    Montpellier, 34295

  • Local Institution

    Nice, 06202

  • Local Institution

    Paris, 75571

  • Local Institution

    Paris, 75679

Other trials in France

Australia4 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local Institution

    Clayton Vic, Victoria, 3168

  • Local Institution

    Heidelberg, Victoria, 3084

  • Local Institution

    Perth, Western Australia, 6001

Other trials in Australia

Germany3 sites

  • Local Institution

    Essen, 45122

  • Local Institution

    Frankfurt, 60590

  • Local Institution

    Hamburg, 20246

Other trials in Germany

Italy2 sites

  • Local Institution

    Pisa, 56124

  • Local Institution

    Roma, 00161

Other trials in Italy

New Zealand2 sites

  • Local Institution

    Christchurch, 8011

  • Local Institution

    Grafton, Auckland, 1010

Other trials in New Zealand

Spain2 sites

  • Local Institution

    Barcelona, Barcelona, 08003

  • Local Institution

    Valencia, 46010

Other trials in Spain

Puerto Rico1 site

  • Fundacion De Investigacion De Diego

    San Juan, 00927

Other trials in Puerto Rico

About this study

Official title: A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naïve Subjects

The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.

Read the detailed description

Study Classification: Pharmacokinetics/ Pharmacodynamics

Conditions
Hepatitis C
Being tested
Pegylated Interferon Lambda (pegIFNλ), BMS-790052 (NS5A Inhibitor), Ribavirin (RBV), BMS-650032 (NS3 Protease Inhibitor), Pegylated Interferon Alfa-2a (pegIFNα-2a)
Medical subject headings
Hepatitis C

What participants receive

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

  • Pegylated Interferon Lambda (pegIFNλ)Biological

    Also called BMS-914143

    Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response

  • BMS-790052 (NS5A Inhibitor)Drug

    Also called BMS-790052

    Tablets, Oral, 60 mg, Once daily, 24 weeks

  • Ribavirin (RBV)Drug

    Also called Ribasphere

    Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks

  • BMS-650032 (NS3 Protease Inhibitor)Drug

    Also called BMS-650032

    Tablets, Oral, 200 mg, Twice daily, 24 weeks

  • Pegylated Interferon Alfa-2a (pegIFNα-2a)Biological

    Also called Pegasys®

    Solution, Subcutaneous, 180 μg/mL, Once weekly, 48 weeks

  • Pegylated Interferon Lambda (pegIFNλ)Biological

    Also called BMS-914143

    Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks

  • Ribavirin (RBV)Drug

    Also called Ribasphere

    Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks

  • Pegylated Interferon Lambda (pegIFNλ)Biological

    Also called BMS-914143

    Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks

  • Ribavirin (RBV)Drug

    Also called Ribasphere

    Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks

  • BMS-790052 (NS5A Inhibitor)Drug

    Also called BMS-790052

    Tablets, Oral, 60 mg, Once daily, 16 weeks

  • BMS-650032 (NS3 Protease Inhibitor)Drug

    Also called BMS-650032

    Tablets, Oral, 200 mg, Twice daily, 16 weeks

  • Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)Drug

    Also called Placebo for BMS-650032

    Tablets, Oral, 0 mg, Twice daily, 24 weeks

  • Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)Drug

    Also called Placebo for BMS-790052

    Tablets, Oral, 0 mg, Once daily, 24 weeks

  • Placebo for Ribavirin (RBV)Drug

    Also called Placebo for Ribasphere

    Tablets, Oral, 0 mg, Twice daily, 24 weeks

  • Placebo for Ribavirin (RBV)Drug

    Also called Placebo for Ribasphere

    Tablets, Oral, 0 mg, Twice daily, 16 weeks

Study groups in NCT01309932
Study groupRoleWhat they receive
A1: pegIFNλ+BMS-790052+Placebo for BMS-650032+RibavirinExperimentalPart A
Receives: Biological: Pegylated Interferon Lambda (pegIFNλ); Drug: BMS-790052 (NS5A Inhibitor); Drug: Ribavirin (RBV); Drug: Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)
A2: pegIFNλ+BMS-650032+Placebo for BMS-790052+RibavirinExperimentalPart A
Receives: Biological: Pegylated Interferon Lambda (pegIFNλ); Drug: Ribavirin (RBV); Drug: BMS-650032 (NS3 Protease Inhibitor); Drug: Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)
A3: pegIFNα-2a+PBO for BMS-790052+PBO for BMS-650032+RBVActive comparatorPart A
Receives: Drug: Ribavirin (RBV); Biological: Pegylated Interferon Alfa-2a (pegIFNα-2a); Drug: Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor); Drug: Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)
A4: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (24 weeks)ExperimentalPart B
Receives: Drug: BMS-790052 (NS5A Inhibitor); Drug: BMS-650032 (NS3 Protease Inhibitor); Biological: Pegylated Interferon Lambda (pegIFNλ); Drug: Ribavirin (RBV)
A5: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (16 weeks)ExperimentalPart B
Receives: Biological: Pegylated Interferon Lambda (pegIFNλ); Drug: Ribavirin (RBV); Drug: BMS-790052 (NS5A Inhibitor); Drug: BMS-650032 (NS3 Protease Inhibitor)
A6: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (24 weeks)ExperimentalPart B
Receives: Drug: BMS-790052 (NS5A Inhibitor); Drug: BMS-650032 (NS3 Protease Inhibitor); Biological: Pegylated Interferon Lambda (pegIFNλ); Drug: Placebo for Ribavirin (RBV)
A7: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (16 weeks)ExperimentalPart B
Receives: Biological: Pegylated Interferon Lambda (pegIFNλ); Drug: BMS-790052 (NS5A Inhibitor); Drug: BMS-650032 (NS3 Protease Inhibitor); Drug: Placebo for Ribavirin (RBV)

What is being measured

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

  1. Safety and tolerability (as measured by the frequency of serious adverse events (SAEs), dose reductions and discontinuations due to adverse events (AEs)

    Measured: Up to end of treatment ( maximum of 48 weeks) plus 30 days

  2. Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24)

    Measured: At end of treatment (maximum of 48 weeks)

  3. Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24)

    Measured: Post-treatment Week 24

Secondary outcomes (14)

  1. Proportion of HCV genotype 1 subjects with Protocol definition of virologic response (PDR) for Part A and Part B

    • Part A PDR is defined as HCV RNA at Week 4 < LLOQ and Week 12 undetectable
    • Part B PDR is defined as HCV RNA at Week 2 ≥ 2 log10 decrease (or < Lower limit of quantitation (LLOQ) if baseline HCV RNA < 2400 IU/mL), Week 4 < LLOQ and Week 12 undetectable

    Measured: Weeks 4, Weeks 12 and post-treatment Weeks 24

  2. Proportion of subjects with either a 2-log or greater decrease in Hepatitis C virus (HCV) Ribonucleic acid (RNA) levels from baseline or undetectable levels of HCV RNA

    Measured: Weeks 2, Weeks 4 and Weeks 12

  3. Proportion of subjects with viral breakthrough, defined as confirmed > 1 log10 increase in HCV RNA over nadir or confirmed HCV RNA ≥ Lower limit of quantitation (LLOQ) after confirmed undetectable HCV RNA while on treatment

    Measured: Post-treatment Week 48

  4. Proportion of subjects with undetectable HCV RNA at the end of treatment that develop detectable levels of HCV RNA in the post-treatment follow-up period

    Measured: Post-treatment Week 48

  5. Serum HCV Ribonucleic acid (RNA) levels over time

    Measured: Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment)

  6. Proportion of subjects with undetectable HCV RNA over time

    Measured: Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment)

  7. Time to viral clearance, defined as an absence of detectable HCV RNA

    Measured: Day 1, 3, Week 1, 2, 4, 6, 8, 12, 24, 36, end of treatment (Week 48), Post-Treatment at Week 4, 12, 24, 36, 48, and 56

  8. Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Maximum observed serum/plasma concentration (Cmax)

    Measured: Cmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)

  9. Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Time to maximum concentration (Tmax)

    Measured: Tmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)

  10. Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Minimal observed serum/plasma concentration (Cmin)

    Measured: Cmin will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)

  11. Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Area under the serum/plasma concentration-time curve during one dose interval AUC(TAU)

    Measured: AUC(TAU) will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)

  12. Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In all subjects, trough concentrations will be assessed (Ctrough)

    Measured: Troughs at baseline (week 0), weeks 2, 4, 8, 12, 16, and 24

  13. Proportion of subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA

    Measured: At end of treatment (maximum of 48 weeks) and follow-up Week 12

  14. Proportion of subjects with 4-week sustained virologic response (SVR4), defined as undetectable HCV RNA

    Measured: At end of treatment (maximum of 48 weeks) and follow-up Week 4

Timeline

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

  1. First posted7 Mar 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionJul 2014
  4. Study completionSep 2014

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
165 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01309932
Sponsor's protocol ID
AI452-008
Other IDs
2010-022568-11
Acronym
D-LITE
Status last verified
Sep 2015
First submitted
4 Mar 2011
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pegylated Interferon Lambda (pegIFNλ), BMS-790052 (NS5A Inhibitor) and Ribavirin (RBV) in people with Hepatitis C, run by Bristol-Myers Squibb at 40 sites in 9 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 4 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 40 sites in United States, Japan, France, Australia, Germany and 4 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?

Safety and tolerability (as measured by the frequency of serious adverse events (SAEs), dose reductions and discontinuations due to adverse events (AEs) (time frame: Up to end of treatment ( maximum of 48 weeks) plus 30 days). The study lists 3 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 NCT01309932.

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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