Hepatitis CPhase 2NCT02556086
A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)
A Phase 2 study testing Daclatasvir and Sofosbuvir in people with Hepatitis C, run by Bristol-Myers Squibb at 17 sites in 2 countries.
Trial summary
The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4… 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 Sofosbuvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 17 sitesin 2 countries
- Study dates
- Dec 2015to Jul 2017
- Phase
- Phase 2
- 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
- HCV RNA < 2000000 IU/mL
- Never taken medication for HCV
- No Liver Cirrhosis
- No advanced fibrosis
- Body mass index(BMI) 18-40 kg/m^2
- Genotype 1-4
Who cannot join
- Infection with HCV other than GT-1, 2, 3 or GT-4 or subjects with mixed infections of any genotype
- Evidence of decompensated liver
- Subjects Infected with HIV 2
- Hepatitis B virus (HBV) coinfection
- Liver Cirrhosis
- Advanced fibrosis (F3-F4)
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
France9 sites
Local Institution
Marseille, 13009
Local Institution
Nantes, 44093
Local Institution
Nice, 06202
Local Institution
Paris, 75010
Local Institution
Paris, 75015
Local Institution
Paris, 75020
Local Institution
Paris, 75679
Local Institution
Paris, 75877
Local Institution
Pessac, 33604
Canada8 sites
Local Institution
Edmonton, Alberta, T6G 2B7
Local Institution
Montreal, Quebec, H4A 3J1
Local Institution
Ottawa, Ontario, K1H 8L6
Local Institution
Québec, Quebec, G1V 4G2
Local Institution
Regina, Saskatchewan, S4P 0W5
Local Institution
Toronto, Ontario, M5G 2N2
Local Institution
Vancouver, British Columbia, V6Z 2C7
Local Institution
Victoria, British Columbia, V8V 3P9
About this study
The purpose of the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.
- Conditions
- Hepatitis C
- Being tested
- Daclatasvir, Sofosbuvir
- 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
SofosbuvirDrug
| Study group | Role | What they receive |
|---|---|---|
| Daclatasvir + Sofosbuvir | Experimental | Daclatasvir 30, 60, 90 mg tablet (dose is dependent on cART regimen) + Sofosbuvir 400 mg tablet oral dosing once daily for 8 weeks Receives: Drug: Daclatasvir; Drug: Sofosbuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with SVR12
SVR12 rate defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection genotype 1-4
Measured: Post treatment follow-up week 12
Secondary outcomes (6)
Sustained virologic response (SVR12) rate
SVR12 rate defined as HCV RNA < lower limit of quantification (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection, by individual genotype (1-4)
Measured: Approximately 2 years
Treatment safety measured by the number of incidence of serious adverse event (SAEs), discontinuations due to adverse event (AEs), Grade 3/4 AEs and Grade 3/4 clinical laboratory abnormalities through the end of treatment
Measured: Approximately 2 years
Proportion of subjects who achieve HCV RNA < LLOQ-TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, EOT, post-treatment Week 4 in subjects on the 8-week regimen of DCV/SOF
Measured: Approximately 2 years
Proportion of subjects who achieve HCV RNA < LLOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, end of treatment (EOT), in subjects on the 8-week regimen of DCV/SOF
Measured: Approximately 2 years
Proportion of subjects receiving cART who maintain HIV virologic suppression
Measured: Approximately 2 years
Proportion of subjects receiving cART who experience HIV virologic failure
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016 (estimated)
- Study completionJul 2017 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT02556086
- Sponsor's protocol ID
- AI444-378
- Other IDs
- 2015-003467-12, 2015
- Status last verified
- Nov 2015
- First submitted
- 15 Sep 2015
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b Evaluation of Daclatasvir/Sofosbuvir in Non-Cirrhotic Treatment Naive Subjects With Genotype 1, 2, 3 and 4 Chronic Hepatitis C Virus Coinfected With Human Immunodeficiency Virus (HIV-1)
- ClinicalTrials.gov ID
- NCT02556086
- Acronym / sponsor ID
- AI444-378
- Conditions
- Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 22 Sep 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 the study is to determine if combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks is safe and effective in patients who have never been treated previously without liver cirrhosis who are chronically infected with hepatitis C virus (HCV)/HIV-1 Coinfection genotype (GT) 1, 2, 3, 4 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daclatasvir + Sofosbuvir | Experimental | Drug: Daclatasvir, Drug: SofosbuvirDaclatasvir 30, 60, 90 mg tablet (dose is dependent on cART regimen) + Sofosbuvir 400 mg tablet oral dosing once daily for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HCV RNA < 2000000 IU/mL
- Never taken medication for HCV
- No Liver Cirrhosis
- No advanced fibrosis
- Body mass index(BMI) 18-40 kg/m^2
Key exclusion criteria (6 listed)
- Infection with HCV other than GT-1, 2, 3 or GT-4 or subjects with mixed infections of any genotype
- Evidence of decompensated liver
- Subjects Infected with HIV 2
- Hepatitis B virus (HBV) coinfection
- Liver Cirrhosis
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 |
|---|---|---|
| Daclatasvir | Drug | Daclatasvir + Sofosbuvir |
| Sofosbuvir | Drug | Daclatasvir + Sofosbuvir |
Primary outcome
Proportion of subjects with SVR12
Time frame: Post treatment follow-up week 12
SVR12 rate defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects infected with HCV/HIV-1 coinfection genotype 1-4
6 secondary outcomes
Sustained virologic response (SVR12) rate
Time frame: Approximately 2 years
Treatment safety measured by the number of incidence of serious adverse event (SAEs), discontinuations due to adverse event (AEs), Grade 3/4 AEs and Grade 3/4 clinical laboratory abnormalities through the end of treatment
Time frame: Approximately 2 years
Proportion of subjects who achieve HCV RNA < LLOQ-TD/TND at each of the following Weeks: 1, 2, 4, 6, 8, EOT, post-treatment Week 4 in subjects on the 8-week regimen of DCV/SOF
Time frame: Approximately 2 years
Proportion of subjects who achieve HCV RNA < LLOQ TND at each of the following Weeks: 1, 2, 4, 6, 8, end of treatment (EOT), in subjects on the 8-week regimen of DCV/SOF
Time frame: Approximately 2 years
Proportion of subjects receiving cART who maintain HIV virologic suppression
Time frame: Approximately 2 years
Proportion of subjects receiving cART who experience HIV virologic failure
Time frame: Approximately 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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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
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daclatasvir and Sofosbuvir in people with Hepatitis C, run by Bristol-Myers Squibb at 17 sites in 2 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 6 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: withdrawn, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France, Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was withdrawn before enrolling participants, so there are no results.
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 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?
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 20 Jan 2016.