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Hepatitis CPhase 3STRUCTURENCT01718158

Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy

A Phase 3 study testing Peginterferon Lambda-1a, Peginterferon Alfa-2a and Ribavirin in people with Hepatitis C, run by Bristol-Myers Squibb at 78 sites in 13 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 treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C
What is being tested?
Peginterferon Lambda-1a, Peginterferon Alfa-2a and Ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
444 participants
Where
78 sitesin 13 countries
Study dates
Jan 2013to Oct 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

  • Patients chronically infected with HCV Genotype-1b
  • Naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined based upon local guidelines)
  • HCV RNA viral load ≥100,000 IU/mL at screening
  • Patients with compensated cirrhosis are permitted

Who cannot join

  • Infection with Hepatitis C virus (HCV) other than Genotype-1b
  • Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)-1/HIV-2 antibody test at screening
  • Evidence of chronic liver disease caused by diseases other than chronic HCV infection
  • Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
  • Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
  • Current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Show all 10Show fewer
  • Laboratory values:
  • Hemoglobin <12.0 g/dL (males) or <11.0 g/dL (females)
  • Platelets <90,000/mm3
  • Total serum bilirubin ≥2 mg/dL (unless due to Gilbert's disease)

Trial locations and contacts

78 sites in 13 countries.

78 sites in 13 countries

Japan19 sites

  • Local Institution

    Gifu, Gifu, 5008727

  • Local Institution

    Higashiibaraki-gun, Ibaraki, 3313193

  • Local Institution

    Hiroshima, Hiroshima, 7348511

  • Local Institution

    Kawasaki-shi, Kanagawa, 2138587

  • Local Institution

    Kitakyushu, Fukuoka, 8030816

  • Local Institution

    Kitakyushu-shi, Fukuoka, 8028533

  • Local Institution

    Kobe, Hyōgo, 6500047

  • Local Institution

    Kumamoto, Kumamoto, 8628655

  • Local Institution

    Kyoto, Kyoto, 6028566

  • Local Institution

    Kyoto, Kyoto, 6128555

  • Local Institution

    Minato-ku, Tokyo, 1058470

  • Local Institution

    Musashino-shi, Tokyo, 1808610

  • Local Institution

    Nagoya, Aichi-ken, 4678602

  • Local Institution

    Saga, Saga-ken, 8408571

  • Local Institution

    Sapporo, Hokkaido, 0600033

  • Local Institution

    Sumida-ku, Tokyo, 1308575

  • Local Institution

    Tanabe-shi, Wakayama, 6468558

  • Local Institution

    Yokohama, Kanagawa, 2320024

  • Local Institution

    Yokohama, Kanagawa, 2458575

Other trials in Japan

United States8 sites

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18102

  • Texas Clinical Research Institute, Llc

    Arlington, Texas, 76012

  • Medvamc

    Houston, Texas, 77030

  • Va Long Beach Healthcare System

    Long Beach, California, 90822

  • Gastrointestinal Specialists Of Georgia Pc

    Marietta, Georgia, 30060

  • Nashville Medical Research Institute

    Nashville, Tennessee, 37205

  • Weill Cornell Medical College

    New York, New York, 10021

  • Premier Medical Group Of The Hudson Valley, Pc

    Poughkeepsie, New York, 12601

Other trials in United States

Russia8 sites

  • Local Institution

    Moscow, 111123

  • Local Institution

    Moscow, 119991

  • Local Institution

    Moscow, 119992

  • Local Institution

    Moscow, 121170

  • Local Institution

    Moscow, 125367

  • Local Institution

    Saint Petersburg, 191167

  • Local Institution

    Saint Petersburg, 196645

  • Local Institution

    Stavropol, 355017

Other trials in Russia

Argentina6 sites

  • Local Institution

    Buenos Aires, Buenos Aires, 1119

  • Local Institution

    Buenos Aires, Buenos Aires, 1221

  • Local Institution

    Buenos Aires, Buenos Aires, C1181

  • Local Institution

    Capital Federal, Buenos Aires, C1405BCK

  • Local Institution

    Mar del Plata, Buenos Aires, B7600FZN

  • Local Institution

    Prov de Santa Fe, Santa Fe Province, 2000

Other trials in Argentina

Taiwan6 sites

  • Local Institution

    Kaohsiung, Taiwan, 80756

  • Local Institution

    Taichung, 404

  • Local Institution

    Tainan, 704

  • Local Institution

    Taipei, 100

  • Local Institution

    Taipei, 112

  • Local Institution

    Taoyuan, 333

Other trials in Taiwan

Germany5 sites

  • Local Institution

    Berlin, 13353

  • Local Institution

    Essen, 45122

  • Local Institution

    Hamburg, 20099

  • Local Institution

    Mannheim, 68167

  • Local Institution

    München, 81377

Other trials in Germany

Italy5 sites

  • Local Institution

    Foggia, 71100

  • Local Institution

    Messina, 98125

  • Local Institution

    Modena, 41100

  • Local Institution

    Pavia, 27100

  • Local Institution

    Pisa, 56124

Other trials in Italy

South Korea5 sites

  • Local Institution

    Busan, 614-735

  • Local Institution

    Seoul, 110-774

  • Local Institution

    Seoul, 135-720

  • Local Institution

    Seoul, 138-736

  • Local Institution

    Seoul, 143-729

Other trials in South Korea

Israel4 sites

  • Local Institution

    Haifa, 34362

  • Local Institution

    Tel Aviv, 64239

  • Local Institution

    Tel HaShomer, 52621

  • Local Institution

    Zafed, 13110

Other trials in Israel

Poland4 sites

  • Local Institution

    Bialystok, 15-540

  • Local Institution

    Lodz, 91-347

  • Local Institution

    Mysłowice, 41-400

  • Local Institution

    Wroclaw, 50-349

Other trials in Poland

Spain4 sites

  • Local Institution

    Barcelona, 08916

  • Local Institution

    Madrid, 28029

  • Local Institution

    Santander, 39008

  • Local Institution

    Zaragoza, 50009

Other trials in Spain

France3 sites

  • Local Institution

    Clichy, 92118

  • Local Institution

    Grenoble, 38043

  • Local Institution

    Villejuif, 94804

Other trials in France

United Kingdom1 site

  • Local Institution

    London, Greater London, SE5 9RS

Other trials in United Kingdom

About this study

Official title: A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naïve or Prior Relapsers to Alfa/RBV Therapy (the STRUCTURE Study)

The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin

Conditions
Hepatitis C
Being tested
Peginterferon Lambda-1a, Peginterferon Alfa-2a, Ribavirin, Daclatasvir, Telaprevir
Medical subject headings
Hepatitis C

What participants receive

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

  • Peginterferon Lambda-1aBiological

    Also called BMS-914143

  • Peginterferon Alfa-2aBiological

    Also called Pegasys®

  • RibavirinDrug

    Also called Copegus®

  • DaclatasvirDrug

    Also called BMS-790052

  • TelaprevirDrug

    Also called Incivek®

Study groups in NCT01718158
Study groupRoleWhat they receive
Peginterferon Lambda-1a + Ribavirin + DaclatasvirExperimentalPeginterferon Lambda-1a 180 µg solution for subcutaneous injection, once a week for 24 Weeks Ribavirin 200 mg tablets [1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects < 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food] by mouth, twice daily, for 24 weeks Daclatasvir 60 mg tablets by mouth, once a day for 12 weeks
Receives: Biological: Peginterferon Lambda-1a; Drug: Ribavirin; Drug: Daclatasvir
Peginterferon Alfa-2a + Ribavirin + TelaprevirExperimentalPeginterferon Alfa-2a 180 µg solution for subcutaneous injection, once a week for 24 to 48 weeks depending on response Ribavirin 200 mg tablets [1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects < 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food] by mouth, twice daily, for 24 to 48 weeks depending on response Telaprevir 375 mg tablets [2250 mg total daily dose: subjects should take 750 mg (two 375 mg tablets) orally three times a day, approximately 7-9 hours apart) for 12 weeks
Receives: Biological: Peginterferon Alfa-2a; Drug: Ribavirin; Drug: Telaprevir

What is being measured

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

  1. Proportion of subjects with Sustained Virologic Response at post-treatment follow-up Week 12 (SVR12)

    Measured: Post treatment follow-up Week 12

Secondary outcomes (13)

  1. Proportion of subjects who achieve SVR12 in treatment-naive subjects

    Measured: Post treatment follow-up Week 12

  2. Proportion of subjects with rash related dermatologic events

    Measured: Up to 12 weeks of treatment

  3. Proportion of subjects who develop treatment emergent cytopenic abnormalities

    Treatment emergent cytopenic abnormalities [anemia as defined by Hemoglobin (Hb) < 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) < 750/mm3, and or thrombocytopenia as defined by platelets < 50,000/mm3]

    Measured: Up to 48 Weeks

  4. Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms

    Measured: Up to 48 Weeks

  5. Proportion of subjects who achieve SVR24 [Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Lower limit of quantitation (LLOQ)] at post-treatment follow-up Week 24

    SVR24 = Sustained virologic response at post treatment follow-up Week 24

    Measured: Post treatment follow-up Week 24

  6. Proportion of subjects with adverse events (AEs), Serious adverse events (SAEs), dose reductions, and discontinuations due to AEs through end of follow-up

    Measured: Maximum of 72 weeks

  7. Proportion of subjects who achieve SVR12 with a 24-week treatment regimen

    Measured: Post treatment follow-up Week 12

  8. Proportion of subjects who achieve Extended rapid virologic response (eRVR) (HCV RNA < LLOQ target not detected at Weeks 4 and 12 of treatment)

    Measured: Weeks 4 and 12 of treatment

  9. Patient Health Questionnaire-9 (PHQ-9) score through end of follow-up

    Measured: Maximum of 72 weeks

  10. Proportion of subjects with treatment emergent laboratory abnormalities by toxicity grade through End of treatment (EOT)

    Measured: Maximum of 72 weeks

  11. Proportion of subjects with the following on-treatment interferon-associated neuropsychiatric symptoms through EOT

    Psychiatric symptoms (depression, irritability or insomnia)

    Measured: Maximum of 48 weeks

  12. Association of Single nucleotide polymorphism (SNPs) in Interleukin 28B (IL28B) (including rs12979860) or equilibrative nucleoside transporter 1 (ENT1) with clinical responses

    For each SNP in each candidate gene, allele and genotype frequencies will be summarized by treatment regimen

    Measured: Post-treatment follow-up Week 12

  13. Resistant variants associated with virologic failure through end of follow-up

    Measured: Maximum of 72 weeks

Timeline

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

  1. First posted31 Oct 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionOct 2014
  4. Study completionOct 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
None (open label)
Enrolment
444 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01718158
Sponsor's protocol ID
AI452-021
Other IDs
2011-005409-65
Acronym
STRUCTURE
Status last verified
Sep 2015
First submitted
29 Oct 2012
Last updated
9 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • Flisiak R, Kawazoe S, Znoyko O, Assy N, Gadano A, Kao JH, Lee KS, Zwirtes R, Portsmouth S, Dong Y, Xu D, Kumada H, Srinivasan S. Peginterferon Lambda-1a/Ribavirin with Daclatasvir or Peginterferon Alfa-2a/Ribavirin with Telaprevir for Chronic Hepatitis C Genotype 1b. J Interferon Cytokine Res. 2016 Nov;36(11):635-643. doi: 10.1089/jir.2015.0173. Epub 2016 Jun 21.

    PubMed 27327078

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Peginterferon Lambda-1a, Peginterferon Alfa-2a and Ribavirin in people with Hepatitis C, run by Bristol-Myers Squibb at 78 sites in 13 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 10 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 78 sites in Japan, United States, Russia, Argentina, Taiwan and 8 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 with 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 NCT01718158, which also lists 1 linked publication.

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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