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Hepatitis C Virus InfectionPhase 3NCT02123654

UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C

A Phase 3 study testing Daclatasvir, Asunaprevir and DCV 3DAA in people with Hepatitis C Virus Infection, run by Bristol-Myers Squibb at 35 sites in Japan.

Completed

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

Official record
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Trial summary

The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA < LOQ target detected or target not… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Hepatitis C Virus Infection
What is being tested?
Daclatasvir, Asunaprevir and DCV 3DAA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
297 participants
Where
35 sitesJapan
Study dates
Apr 2014to Aug 2015
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females, ≥ 20 years of age
  • Subjects chronically infected with HCV GT-1
  • HCV RNA viral load of ≥ 100,000 IU/mL

Who cannot join

  • Hepatocellular carcinoma
  • Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
  • Severe or uncontrollable complication

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

Japan35 sites

  • Local Institution

    Bunkyo-ku, Tokyo, 1138655

  • Local Institution

    Chuo-shi, Yamanashi, 4093898

  • Local Institution

    Fukui-shi, Fukui, 9188503

  • Local Institution

    Fukuoka, Fukuoka, 8108563

  • Local Institution

    Gifu, Gifu, 5008513

  • Local Institution

    Hiroshima, Hiroshima, 7348551

  • Local Institution

    Iruma-gun, Saitama, 3500495

  • Local Institution

    Kagoshima, Kagoshima-ken, 8908520

  • Local Institution

    Kanazawa, Ishikawa-ken, 9208641

  • Local Institution

    Kashihara, Nara, 6348522

  • Local Institution

    Kawasaki-shi, Kanagawa, 2138587

  • Local Institution

    Kobe, Hyōgo, 6500047

  • Local Institution

    Kumamoto, Kumamoto, 8628655

  • Local Institution

    Kurume-shi, Fukuoka, 8300011

  • Local Institution

    Kyoto, Kyoto, 6028566

  • Local Institution

    Minato-ku, Tokyo, 1058470

  • Local Institution

    Miyazaki, Miyazaki, 8800003

  • Local Institution

    Musashino-shi, Tokyo, 1808610

  • Local Institution

    Nagoya, Aichi-ken, 466-8560

  • Local Institution

    Nagoya, Aichi-ken, 4678602

  • Local Institution

    Nishinomiya-shi, 6638501

  • Local Institution

    Ogaki-shi, Gifu, 5038502

  • Local Institution

    Okayama, Okayama-ken, 7008558

  • Local Institution

    Osaka, Osaka, 5438555

  • Local Institution

    Osaka, Osaka, 5458586

  • Local Institution

    Saga, Saga-ken, 8408571

  • Local Institution

    Sapporo, Hokkaido, 0600033

  • Local Institution

    Sapporo, Hokkaido, 0608648

  • Local Institution

    Shinjuku-Ku, Tokyo, 1608582

  • Local Institution

    Suita, Osaka, 5640013

  • Local Institution

    Suita-shi, Osaka, 5650871

  • Local Institution

    Takamatsu, Kagawa-ken, 7608557

  • Local Institution

    Takasaki, Gunma, 3700829

  • Local Institution

    Yamagata, Yamagata, 9909585

  • Local Institution

    Yokohama, Kanagawa, 2320024

Other trials in Japan

About this study

Official title: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Treatment-Naive and IFN Experienced Subjects With Genotype 1 Chronic Hepatitis C

The purpose of this study is to demonstrate that the proportion of treatment-naive non-cirrhotic subjects with Genotype (GT)-1b treated with Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325 who achieve Sustained Virologic response (SVR12), defined as Hepatitis C virus (HCV) RNA < LOQ target detected or target not detected (LOQ TD/TND) at follow-up Week 12, is significantly higher than SVR12 of current Standard of Care (SOC).

Read the detailed description

Limit of Quantitation (LOQ)

Ribonucleic acid (RNA)

End of Treatment (EOT)

Triple Direct Acting Antivirals (3DAA)

Being tested
Daclatasvir, Asunaprevir, DCV 3DAA, Placebo for DCV 3DAA, Placebo for 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.

  • DaclatasvirDrug

  • AsunaprevirDrug

  • DCV 3DAADrug

    Also called Daclatasvir 30 mg /Asunaprevir 200 mg /BMS-791325 75 mg fixed dose combination

  • Placebo for DCV 3DAAOther

  • Placebo for DaclatasvirOther

  • Placebo for AsunaprevirOther

Study groups in NCT02123654
Study groupRoleWhat they receive
Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASVExperimentalDCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind)
Receives: Drug: DCV 3DAA; Other: Placebo for Daclatasvir; Other: Placebo for Asunaprevir
Arm 2: DCV/ASV + Placebo for DCV 3DAAActive comparatorDaclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind)
Receives: Drug: Daclatasvir; Drug: Asunaprevir; Other: Placebo for DCV 3DAA
DCV 3DAAExperimentalDCV 3DAA (open label) Tablet orally twice daily for 12 weeks
Receives: Drug: DCV 3DAA

What is being measured

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

  1. Proportion of treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12

    Measured: After 12 weeks of the last dose

Secondary outcomes (10)

  1. The proportion of treatment-naive subjects who achieve SVR12 with DCV/ASV/BMS-791325 or DCV/ASV

    Measured: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24

  2. The proportion of Interferon (IFN) experienced subjects who achieve SVR12 with DCV/ASV/BMS-791325

    Measured: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24

  3. The proportion of subjects who achieve HCV RNA < LOQ TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)

    Measured: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24

  4. The proportion of subjects who achieve HCV RNA < LOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT; post-treatment Weeks 4, 8, 12 and 24

    Measured: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24

  5. On-treatment safety as measured by the frequency of Serious Adverse Event (SAEs), discontinuations due to Adverse Event (AEs), and selected Grade 3 - 4 laboratory abnormalities

    based on the US National Institutes of Health Division of AIDs (DAIDS) criteria

    Measured: Approximately 48 weeks

  6. The proportion of subjects with anemia defined as Hb < 10 g/dL on-treatment who had Hb ≥ 10 g/dL at baseline

    Measured: Approximately 48 weeks

  7. The proportion of subjects in each cohort who achieve SVR12 associated with HCV genotype subtype 1a vs 1b

    Measured: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24

  8. The proportion of subjects in each cohort who achieve SVR12 associated with IL28B Single Nucleotide Polymorphisms (SNP) status

    Measured: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24

  9. The proportion of cirrhotic and non-cirrhotic subjects who achieve SVR12

    Measured: Weeks: 1, 2, 4, 6, 8, 12, 16, 20 and 24; EOT (week 12 or 24); post-treatment Weeks 4, 8, 12 and 24

  10. On-treatment safety of non-cirrhotic vs cirrhotic subjects, as measured by the frequency of SAEs, discontinuations due to AEs, and selected Grade 3 - 4 laboratory abnormalities on DAIDS criteria

    Measured: Approximately 48 weeks

Timeline

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

  1. First posted25 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJan 2015
  4. Study completionAug 2015

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
Double blind
Who is masked
Participant, Investigator
Enrolment
297 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02123654
Sponsor's protocol ID
AI443-117
Status last verified
Aug 2015
First submitted
10 Apr 2014
Last updated
18 Sep 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Daclatasvir, Asunaprevir and DCV 3DAA in people with Hepatitis C Virus Infection, run by Bristol-Myers Squibb at 35 sites in Japan.

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 3 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 18 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Japan. 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 treated subjects who achieve SVR12 in treatment-naive non-cirrhotic subjects treated with DCV/ASV/BMS-791325, defined as HCV RNA < LOQ target detected or target not detected (LOQ TD/TND) at post-treatment follow-up Week 12 (time frame: After 12 weeks of the last dose). 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 NCT02123654.

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 18 Sep 2015.

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