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Hepatitis C Virus (HCV)Phase 3PRINCIPALNCT01616524

Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3

A Phase 3 study testing Pegylated interferon lambda (pegIFNλ), Pegylated interferon alfa-2a (pegIFNα-2a) and Ribavirin in people with Hepatitis C Virus (HCV), run by Bristol-Myers Squibb at 124 sites in 19 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 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C Virus (HCV)
What is being tested?
Pegylated interferon lambda (pegIFNλ), Pegylated interferon alfa-2a (pegIFNα-2a) and Ribavirin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
880 participants
Where
124 sitesin 19 countries
Study dates
Jul 2012to Sep 2014
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Chronic hepatitis C, Genotype 2 or 3
  • Naïve to prior anti-HCV therapy

Who cannot join

  • Infected with HCV other than Genotype 2 or 3
  • Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
  • Evidence of liver disease other than HCV
  • Active substance abuse
  • Evidence of decompensated cirrhosis

Trial locations and contacts

124 sites in 19 countries.

124 sites in 19 countries

Japan19 sites

  • Local Institution

    Bunkyo-ku, Tokyo, 1138655

  • Local Institution

    Fukuoka, Fukuoka, 8108563

  • Local Institution

    Fukuoka, Fukuoka, 8158555

  • Local Institution

    Hiroshima, Hiroshima, 7348551

  • Local Institution

    Iruma-gun, Saitama, 3500495

  • Local Institution

    Kagoshima, Kagoshima-ken, 8908520

  • Local Institution

    Kawasaki-shi, Kanagawa, 2138587

  • Local Institution

    Kitakyushu, Fukuoka, 8030816

  • Local Institution

    Kobe, Hyōgo, 6500047

  • Local Institution

    Minato-ku, Tokyo, 1058470

  • Local Institution

    Miyazaki, Miyazaki, 8800003

  • Local Institution

    Musashino-shi, Tokyo, 1808610

  • Local Institution

    Okayama, Okayama-ken, 7008558

  • Local Institution

    Saga, Saga-ken, 8408571

  • Local Institution

    Saitama, Saitama, 3380001

  • Local Institution

    Sapporo, Hokkaido, 0600033

  • Local Institution

    Takamatsu, Kagawa-ken, 7608557

  • Local Institution

    Tsuchiura-shi, Ibaraki, 300-0053

  • Local Institution

    Wakayama, Wakayama, 6408158

Other trials in Japan

United States18 sites

  • Texas Clinical Research Institute, Llc

    Arlington, Texas, 76012

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • Consultants For Clinical Research

    Cincinnati, Ohio, 45249

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • The Queen'S Liver Center

    Honolulu, Hawaii, 96813

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

    Houston, Texas, 77030

  • Gastrointestinal Specialists Of Georgia

    Marietta, Georgia, 30060

  • Clinical Research Centers Of America

    Murray, Utah, 84123

  • Yale University School Of Medicine

    New Haven, Connecticut, 06510

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Orlando Infectious Disease Center

    Orlando, Florida, 32806

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • University Of Pittsburgh Medical Center, Ctr For Liver Diseases

    Pittsburgh, Pennsylvania, 15213

  • Precision Research Institute, Llc

    San Diego, California, 92114

  • Medical Associates Research Group

    San Diego, California, 92123

  • University Of California, San Francisco/Sf General Hospital

    San Francisco, California, 94110

  • Kaiser Permanente Medical Center

    San Francisco, California, 94118

  • Healthcare Research Consultants

    Tulsa, Oklahoma, 74135

Other trials in United States

Australia14 sites

  • Local Institution

    Adelaide, South Australia, 5000

  • Local Institution

    Brisbane, Queensland, 4102

  • Local Institution

    Camperdown, New South Wales, 2050

  • Local Institution

    Clayton Vic, Victoria, 3168

  • Local Institution

    Concord, New South Wales, 2139

  • Local Institution

    Darlinghurst, New South Wales, 2010

  • Local Institution

    Fitzroy, Victoria, 3065 VIC

  • Local Institution

    Fremantle, Western Australia, 6160

  • Local Institution

    Greenslopes, Queensland, 4120

  • Local Institution

    Herston, Queensland, 4029

  • Local Institution

    Melbourne, Victoria, 3004

  • Local Institution

    Parville, Victoria, 3050

  • Local Institution

    Randwick, New South Wales, 2031

  • Local Institution

    Westmead Nsw, New South Wales, 2145

Other trials in Australia

Russia12 sites

  • Local Institution

    Chelyabinsk, 454052

  • Local Institution

    Irkutsk, 664003

  • Local Institution

    Krasnoyarsk, 660049

  • Local Institution

    Moscow, 107996

  • Local Institution

    Moscow, 117593

  • Local Institution

    Moscow, 119992

  • Local Institution

    Moscow, 121170

  • Local Institution

    Saint Petersburg, 190103

  • Local Institution

    Saint Petersburg, 194044

  • Local Institution

    Saint Petersburg, 197376

  • Local Institution

    Samara, 443063

  • Local Institution

    Smolensk, 214018

Other trials in Russia

South Korea12 sites

  • Local Institution

    Busan, 602-739

  • Local Institution

    Busan, 614-735

  • Local Institution

    Daegu, 700-721

  • Local Institution

    Daegu, 705-703

  • Local Institution

    Gyeonggi-do, 425-707

  • Local Institution

    Gyeonggi-do, 443-380

  • Local Institution

    Gyeongsangnam-do, 626-770

  • Local Institution

    Incheon, 400-711

  • Local Institution

    Incheon, 403-720

  • Local Institution

    Seoul, 120-752

  • Local Institution

    Seoul, 135-710

  • Local Institution

    Seoul, 138-736

Other trials in South Korea

Argentina8 sites

  • Local Institution

    Autonoma, Buenos Aires, C1119ACN

  • Local Institution

    Buenos Aires, Buenos Aires, C1280AEB

  • Local Institution

    Ciudad de Buenos Aires, Buenos Aires, C1121ABE

  • Local Institution

    Ciudad de Buenos Aires, Buenos Aires, C1181ACH

  • Local Institution

    Córdoba, Córdoba Province, 5000

  • Local Institution

    Mar del Plata, Buenos Aires, 7600

  • Local Institution

    Prov de Santa Fe, Santa Fe Province, 2000

  • Local Institution

    Quilmes, Buenos Aires, B1878DVB

Other trials in Argentina

Mexico8 sites

  • Local Institution

    Distrito Federal, Mexico City, 03720

  • Local Institution

    Guadalajara, Jalisco, 44500

  • Local Institution

    Guadalajara, Jalisco, 44650

  • Local Institution

    Guadalajara

  • Local Institution

    Mexico City, Mexico City, 06726

  • Local Institution

    Mexico City, Mexico City, 07760

  • Local Institution

    Mexico City, 06700

  • Local Institution

    Tlalpan, Mexico City, 14000

Other trials in Mexico

Italy5 sites

  • Local Institution

    Florence, 50134

  • Local Institution

    Milan, 20122

  • Local Institution

    Milan, 20142

  • Local Institution

    Naples, 80131

  • Local Institution

    Novara, 28100

Other trials in Italy

Taiwan5 sites

  • Local Institution

    Kaohsiung City, 80756

  • Local Institution

    Kaohsiung City, 833

  • Local Institution

    Taichung, 402

  • Local Institution

    Tainan, 704

  • Local Institution

    Yunlin, 64041

Other trials in Taiwan

France4 sites

  • Local Institution

    Clichy, 92118

  • Local Institution

    Créteil, 94010

  • Local Institution

    Montpellier, 34295

  • Local Institution

    Nice, 06202

Other trials in France

United Kingdom4 sites

  • Local Institution

    Birmingham, West Midlands, B15 2TH

  • Local Institution

    Hull, Humberside, HU3 2JZ

  • Local Institution

    London, E1 1BB

  • Local Institution

    Nottingham, Nottinghamshire, NG7 2UH

Other trials in United Kingdom

Belgium3 sites

  • Local Institution

    Brussels, 1070

  • Local Institution

    Leuven, 3000

  • Local Institution

    Liège, 4000

Other trials in Belgium

Singapore3 sites

  • Local Institution

    Singapore, 119228

  • Local Institution

    Singapore, 169608

  • Local Institution

    Singapore, 529889

Other trials in Singapore

Greece2 sites

  • Local Institution

    Athens, 115 23

  • Local Institution

    Thessaloniki, 54006

Other trials in Greece

Hong Kong2 sites

  • Local Institution

    Hong Kong

  • Local Institution

    Tai Po

Other trials in Hong Kong

Netherlands2 sites

  • Local Institution

    Amsterdam, 1105 AZ

  • Local Institution

    Leiden, 2333 ZA

Other trials in Netherlands

Chile1 site

  • Local Institution

    Santiago, Santiago Metropolitan

Other trials in Chile

Finland1 site

  • Local Institution

    Hus, 00029

Other trials in Finland

New Zealand1 site

  • Local Institution

    Auckland, 92024

Other trials in New Zealand

About this study

Official title: A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects

The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

Being tested
Pegylated interferon lambda (pegIFNλ), Pegylated interferon alfa-2a (pegIFNα-2a), Ribavirin, Daclatasvir, Placebo matching Daclatasvir
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

    Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks

  • Pegylated interferon lambda (pegIFNλ)Biological

    Also called BMS-914143

    Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks

  • Pegylated interferon alfa-2a (pegIFNα-2a)Biological

    Also called Pegasys

    Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks

  • RibavirinDrug

    Also called Ribasphere

    Tablets, Oral, 400 mg, Twice daily, 24 weeks

  • RibavirinDrug

    Also called Ribasphere

    Tablets, Oral, 400 mg, Twice daily, 12 weeks

  • DaclatasvirDrug

    Also called BMS-790052

    Tablets, Oral, 60 mg, Once daily, 12 weeks

  • Placebo matching DaclatasvirDrug

    Tablets, Oral, 0 mg, Once daily, 12 weeks

Study groups in NCT01616524
Study groupRoleWhat they receive
Arm 1: pegIFNλ + Ribavirin + Placebo matching DaclatasvirExperimentalNot described
Receives: Biological: Pegylated interferon lambda (pegIFNλ); Drug: Ribavirin; Drug: Placebo matching Daclatasvir
Arm 2: pegIFNλ + Ribavirin + DaclatasvirExperimentalNot described
Receives: Biological: Pegylated interferon lambda (pegIFNλ); Drug: Ribavirin; Drug: Daclatasvir
Arm 3: pegIFNα-2a + Ribavirin + Placebo matching DaclatasvirExperimentalNot described
Receives: Biological: Pegylated interferon alfa-2a (pegIFNα-2a); Drug: Ribavirin; Drug: Placebo matching Daclatasvir

What is being measured

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

  1. Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)

    Measured: Post-treatment follow-up week 12

Secondary outcomes (10)

  1. Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)]

    Measured: On-treatment Week 4

  2. Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3)

    Hb = Hemoglobin ANC = Absolute neutrophil count

    Measured: Up to week 12 or week 24

  3. Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain)

    Measured: Up to week 12 or week 24

  4. Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)

    Measured: Up to week 12 or week 24

  5. Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group

    Measured: Post-treatment week 24

  6. Proportion of subjects with on-treatment Serious adverse events (SAEs)

    Measured: Up to week 12 or week 24

  7. Proportion of subjects with dose reductions

    Measured: Up to week 12 or week 24

  8. Proportion of subjects who discontinue due to Adverse events (AEs)

    Measured: Up to week 12 or week 24

  9. Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection

    Measured: Post-treatment follow-up week 12

  10. Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia)

    Measured: Up to week 12 or week 24

Timeline

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

  1. First posted11 Jun 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJun 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
880 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01616524
Sponsor's protocol ID
AI452-017
Other IDs
2011-004885-14
Acronym
PRINCIPAL
Status last verified
Sep 2015
First submitted
7 Jun 2012
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegylated interferon lambda (pegIFNλ), Pegylated interferon alfa-2a (pegIFNα-2a) and Ribavirin in people with Hepatitis C Virus (HCV), run by Bristol-Myers Squibb at 124 sites in 19 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 2 inclusion and 5 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 124 sites in Japan, United States, Australia, Russia, South Korea and 14 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12) (time frame: Post-treatment follow-up week 12). 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 NCT01616524.

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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