Hepatitis C VirusPhase 3UNITY 4NCT02170727
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
A Phase 3 study testing DCV/ASV/BMS-791325 in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 20 sites in 3 countries.
Trial summary
To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C Virus
- What is being tested?
- DCV/ASV/BMS-791325
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 20 sitesin 3 countries
- Study dates
- 26 Jun 2014to 9 Sep 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject chronically infected with HCV genotype 1 (GT-1)
- Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A)
- HCV RNA ≥ 10,000 IU/mL at screening
- Treatment-naïve subject with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)
- Interferon (IFN) experienced subject who have received previous treatment with IFNα, with or without RBV
Who cannot join
- Liver or any other transplant (including hematopoietic stem cell transplants) other than cornea and hair;
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening;
- Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed);
- Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Trial locations and contacts
20 sites in 3 countries.
20 sites in 3 countries
South Korea10 sites
Local Institution
Busan, 602-739
Local Institution
Busan, 614-735
Local Institution
Gyeonggi-do, 463-707
Local Institution
Gyeonggi-do, 480-717
Local Institution
Gyeongsangnam-do, 626-770
Local Institution
Inchoen, 405-760
Local Institution
Seoul, 120-752
Local Institution
Seoul, 135-710
Local Institution
Seoul, 138-736
Local Institution
Seoul, 156-755
Taiwan8 sites
Local Institution
Kaohsiung City, 807
Local Institution
Kaohsiung City, 833
Local Institution
Taichung, 40447
Local Institution
Taichung, 40705
Local Institution
Tainan, 704
Local Institution
Taipei, 100
Local Institution
Taipei, 112
Local Institution
Taoyuan, 333
About this study
To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.
Read the detailed description
US National Institutes of Health Division of AIDs (DAIDS)
- Conditions
- Hepatitis C Virus
- Being tested
- DCV/ASV/BMS-791325
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DCV/ASV/BMS-791325Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 : DCV/ASV/BMS-791325 | Experimental | DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks Receives: Drug: DCV/ASV/BMS-791325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort
Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.
Measured: Post treatment Week 12
Secondary outcomes (11)
Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort
Percentage of treated participants with SVR12 in the IFNα experienced cohort, defined as HCV RNA < LLOQ target detected or target not detected (LLOQ TD/TND).
Measured: Post treatment Week 12
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Percentage of Participants with hepatitis C virus(HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, EOT, and follow-up Weeks 4 (SVR4), 8 (SVR8), and 24 (SVR24).
Measured: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment)
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Percentage of treated participants with HCV RNA < LLOQ, TND (target not detected) were presented at treatment Weeks 1, 2, 4, 6, 8, 12, at both Weeks 4 and 12, EOT, and follow-up Weeks 4, 8, 12 and 24.
Measured: On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment)
Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/ birth defect.
Measured: Up to post treatment week 4
Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline
Anemia was defined as hemoglobin < 10 g/dL on-treatment for subjects who had hemoglobin >= 10 g/dL at baseline.
Measured: Up to post treatment week 4
Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b
Percentage of subjects in each cohort who achieved SVR12 associated with HCV genotype subtype 1a vs 1b were reported.
Measured: Post treatment week 12
Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype)
Proportion of Participants who Achieved SVR12 Associated with IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) status (CC genotype or non CC genotype) were reported.
Measured: Post treatment Week 12
Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12
Proportion of Cirrhotic and Non Cirrhotic Participants who Achieved SVR12 were reported.
Measured: Post treatment Week 12
Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
Rates of selected Grade 3 - 4 laboratory abnormalities on treatment in each cohort was estimated
Measured: Post treatment week 4
Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs
Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the frequency of SAEs, discontinuations due to AEs was conducted.
Measured: Up to post treatment week 4
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Subgroup analysis of on-treatment safety with non-cirrhosis vs cirrhosis, as measured by the selected Grade 3 - 4 laboratory abnormalities (including hematologic and liver function, based on DAIDS criteria) was conducted.
Measured: Up to post treatment week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study start26 Jun 2014
- Primary completion12 Jun 2015
- Study completion9 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170727
- Sponsor's protocol ID
- AI443-123
- Acronym
- UNITY 4
- Status last verified
- Oct 2020
- First submitted
- 20 Jun 2014
- Last updated
- 29 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
- ClinicalTrials.gov ID
- NCT02170727
- Acronym / sponsor ID
- UNITY 4 / AI443-123
- Conditions
- Hepatitis C Virus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2014 (actual)
- Primary completion
- 12 Jun 2015 (actual)
- Study completion
- 9 Sep 2015 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Posted 16 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.
Detailed description
US National Institutes of Health Division of AIDs (DAIDS)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 : DCV/ASV/BMS-791325 | Experimental | Drug: DCV/ASV/BMS-791325DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subject chronically infected with HCV genotype 1 (GT-1)
- Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A)
- HCV RNA ≥ 10,000 IU/mL at screening
- Treatment-naïve subject with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)
- Interferon (IFN) experienced subject who have received previous treatment with IFNα, with or without RBV
Key exclusion criteria (4 listed)
- Liver or any other transplant (including hematopoietic stem cell transplants) other than cornea and hair;
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening;
- Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed);
- Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DCV/ASV/BMS-791325 | Drug | Arm 1 : DCV/ASV/BMS-791325 |
Primary outcome
Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort
Time frame: Post treatment Week 12
Percentage of Participants with SVR12 in the naive cohort, defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) (LOQ TD/TND) at post-treatment follow-up Week 12.
11 secondary outcomes
Percentage of Participants With SVR12 in the Interferon Alfa (IFN-a) Experienced Cohort
Time frame: Post treatment Week 12
Percentage of Participants Who Achieved HCV RNA < LLOQ TD/TND
Time frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8), 24 (SVR24) and EOT (end of treatment)
Percentage of Participants Who Achieved HCV RNA < LLOQ TND
Time frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12 and post treatment weeks 4, 8, 12, 24 and EOT (end of treatment)
Number of Participants With Deaths, Serious Adverse Events (SAEs) and AEs Leading to Discontinuation From Treatment
Time frame: Up to post treatment week 4
Percentage of Participants With Anemia Defined as Hb < 10 g/dL On-treatment Who Had Hb >=10 g/dL at Baseline
Time frame: Up to post treatment week 4
Percentage of Participants Who Achieved SVR12 Associated With Hepatitis C Virus (HCV) Genotype Subtype 1a vs 1b
Time frame: Post treatment week 12
Proportion of Participants Who Achieved SVR12 Associated With IL28B rs12979860 Single Nucleotide Polymorphisms (SNP) Status (CC Genotype or Non CC Genotype)
Time frame: Post treatment Week 12
Proportion of Cirrhotic and Non Cirrhotic Participants Who Achieved SVR12
Time frame: Post treatment Week 12
Number of Participants With Selected Grade 3/4 Laboratory Abnormalities
Time frame: Post treatment week 4
Number of Participants With/Without Cirrhosis as Measured by SAEs and Discontinuations Due to AEs
Time frame: Up to post treatment week 4
Number of Participants With/Without Cirrhosis as Measured by Selected Grade 3-4 Laboratory Abnormalities
Time frame: Up to post treatment week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
20 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DCV/ASV/BMS-791325 in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 20 sites in 3 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 5 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 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in South Korea, Taiwan, Russia. 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?
Yes. Results are posted in the registry (first posted 16 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Sustained Virologic Response 12 (SVR12) in the Naive Cohort (time frame: Post treatment Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Oct 2020.