Hepatitis CPhase 3NCT02496078
A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection
A Phase 3 study testing Daclatasvir and Asunaprevir in people with Hepatitis C, run by Bristol-Myers Squibb at 29 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection. 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?
- Daclatasvir and Asunaprevir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 29 sitesin 3 countries
- Study dates
- Aug 2015to Feb 2017
- 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
- No previous exposure to any interferon formulation, Ribavirin (RBV), and HCV direct acting antiviral agent
- HCV RNA viral load ≥ 10,000 IU/mL at screening
- Seronegative for HIV and HBsAg
- BMI of 18-35 kg/m2, inclusive
- Patients with compensated cirrhosis are permitted
Who cannot join
- Infection with HCV other than genotype (GT) -1b
- Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
- Evidence of a medical condition contributing to chronic liver disease other than HCV
- Diagnosed or suspected hepatocellular carcinoma or other malignancies
- Uncontrolled diabetes or hypertension
- History of moderate to severe depression. Well-controlled mild depression is allowed
Show all 9Show fewer
- Confirmed alanine aminotransferase (ALT) ≥ 5x Upper Limit of Normal (ULN)
- Confirmed platelet count < 50,000 cells/mm3
- Confirmed hemoglobin < 8.5 g/dL
Trial locations and contacts
29 sites in 3 countries.
29 sites in 3 countries
China23 sites
Local Institution
Beijing, Beijing Municipality, 100015
Local Institution
Beijing, Beijing Municipality, 100034
Local Institution
Beijing, Beijing Municipality, 100050
Local Institution
Beijing, Beijing Municipality, 100054
Local Institution
Beijing, 100039
Local Institution
Changchun, Jilin, 130021
Local Institution
Changsha, Hunan, 410008
Local Institution
Chengdu, Sichuan, 610041
Local Institution
Guangzhou, Guangdong, 510060
Local Institution
Guangzhou, Guangdong, 510515
Local Institution
Nanjing, Jiangsu, 210002
Local Institution
Nanjing, Jiangsu, 210003
Local Institution
Nanjing, Jiangsu, 210029
Local Institution
Qingdao, Shandong, 266011
Local Institution
Shanghai, Shanghai Municipality, 200025
Local Institution
Shanghai, Shanghai Municipality, 200062
Local Institution
Shanghai, Shanghai Municipality, 200083
Local Institution
Shenyang, Liaoning, 110002
Local Institution
Shenyang, Liaoning, 110006
Local Institution
Shijiazhuang, Hebei, 050051
Local Institution
Xi’an, Shanxi, 710038
Local Institution
Xi’an, Shanxi, 710061
Local Institution
Zhenjiang, Jiangsu, 212000
Russia3 sites
Local Institution
Moscow, 127015
Local Institution
Saint Petersburg, 190103
Local Institution
Saint Petersburg, 191167
South Korea3 sites
Local Institution
Busan, 47392
Local Institution
Seoul, 07061
Local Institution
Seoul, 08308
About this study
The purpose of this study is to determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection.
- Conditions
- Hepatitis C
- Being tested
- Daclatasvir, Asunaprevir
- 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
Daclatasvir tablet 60mg
AsunaprevirDrug
Asunaprevir soft capsule 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Active dual arm | Active comparator | Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from day 1 to 12 week
Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 24 week and follow up to week 48 Receives: Drug: Daclatasvir; Drug: Asunaprevir |
| Placebo arm | Placebo comparator | Daclatasvir placebo in tablet form QD and Asunaprevir placebo in soft capsule form BID from day 1 to 12 week
Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 36 week and follow up to week 60 Receives: Drug: Daclatasvir; Drug: Asunaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12)
HCV RNA < Lower limit of quantitation (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12
Measured: Post-treatment Week 12
Secondary outcomes (10)
Proportion of subjects with anemia on active Dual therapy
Measured: Post-treatment Week 12
Proportion of subjects with neutropenia on active Dual therapy
Measured: Post-treatment Week 12
Proportion of subjects with thrombocytopenia on active Dual therapy
Measured: Post-treatment Week 12
On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Measured: Post-treatment week 12
Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO)
Measured: first 12 weeks on treatment
Differences in rates of selected Grade 3-4 laboratory abnormalities for liver function between treatments (DCV + Asunaprevir (ASV) vs PBO)
Measured: first 12 weeks on treatment
Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort
Measured: Post-treatment visit week 12
Proportion of subjects with hepatitis C virus (HCV) RNA < LLOQ-TD/TND in each arm at various intervals after the initiation of active Dual therapy
Measured: post-treatment visit Week 24
Proportion of subjects who achieve HCV RNA < LLOQ-TND at each arm at various intervals after the initiation of active Dual therapy
Measured: post-treatment visit Week 24
Proportion of treated subjects with SVR12 for subjects randomized to placebo
Measured: Post-treatment visit week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 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
- NCT02496078
- Sponsor's protocol ID
- AI447-114
- Status last verified
- Sep 2016
- First submitted
- 9 Jul 2015
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection
- ClinicalTrials.gov ID
- NCT02496078
- Acronym / sponsor ID
- AI447-114
- Conditions
- Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active dual arm | Active comparator | Drug: Daclatasvir, Drug: AsunaprevirDaclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from day 1 to 12 week Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 24 week and follow up to week 48 |
| Placebo arm | Placebo comparator | Drug: Daclatasvir, Drug: AsunaprevirDaclatasvir placebo in tablet form QD and Asunaprevir placebo in soft capsule form BID from day 1 to 12 week Daclatasvir in tablet form at the dose of 60 mg QD and Asunaprevir in soft capsule form at the dose of 100 mg BID from 12 to 36 week and follow up to week 60 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients chronically infected with HCV Genotype 1b
- No previous exposure to any interferon formulation, Ribavirin (RBV), and HCV direct acting antiviral agent
- HCV RNA viral load ≥ 10,000 IU/mL at screening
- Seronegative for HIV and HBsAg
- BMI of 18-35 kg/m2, inclusive
Key exclusion criteria (9 listed)
- Infection with HCV other than genotype (GT) -1b
- Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
- Evidence of a medical condition contributing to chronic liver disease other than HCV
- Diagnosed or suspected hepatocellular carcinoma or other malignancies
- Uncontrolled diabetes or hypertension
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 |
|---|---|---|
| DaclatasvirDaclatasvir tablet 60mg | Drug | Active dual arm, Placebo arm |
| AsunaprevirAsunaprevir soft capsule 100 mg | Drug | Active dual arm, Placebo arm |
Primary outcome
Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12)
Time frame: Post-treatment Week 12
HCV RNA < Lower limit of quantitation (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12
10 secondary outcomes
Proportion of subjects with anemia on active Dual therapy
Time frame: Post-treatment Week 12
Proportion of subjects with neutropenia on active Dual therapy
Time frame: Post-treatment Week 12
Proportion of subjects with thrombocytopenia on active Dual therapy
Time frame: Post-treatment Week 12
On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)
Time frame: Post-treatment week 12
Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO)
Time frame: first 12 weeks on treatment
Differences in rates of selected Grade 3-4 laboratory abnormalities for liver function between treatments (DCV + Asunaprevir (ASV) vs PBO)
Time frame: first 12 weeks on treatment
Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort
Time frame: Post-treatment visit week 12
Proportion of subjects with hepatitis C virus (HCV) RNA < LLOQ-TD/TND in each arm at various intervals after the initiation of active Dual therapy
Time frame: post-treatment visit Week 24
Proportion of subjects who achieve HCV RNA < LLOQ-TND at each arm at various intervals after the initiation of active Dual therapy
Time frame: post-treatment visit Week 24
Proportion of treated subjects with SVR12 for subjects randomized to placebo
Time frame: Post-treatment visit week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2017.
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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
29 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 Daclatasvir and Asunaprevir in people with Hepatitis C, run by Bristol-Myers Squibb at 29 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 6 inclusion and 9 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 19 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in China, Russia, South Korea. 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. Some participants in this study may receive a placebo. 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 randomized to Active Dual therapy with Sustained Virologic Response (SVR12) (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 19 Apr 2017.