Hepatitis CPhase 2NCT02551861
A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3
A Phase 2 study testing Daclatasvir, Sofosbuvir and Ribavirin in people with Hepatitis C, run by Bristol-Myers Squibb at 12 sites in 2 countries.
Trial summary
The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously. 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, Sofosbuvir and Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Dec 2015to Jun 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
- Genotype 3
- HCV RNA < 2000000 IU/mL
- Never taken HCV medication
- Absence of advanced fibrosis or cirrhosis
- Body mass index (BMI) 18-40 kg/m^2
Who cannot join
- Infection with HCV other than genotype 3 (GT3); Mixed infections of any genotype
- Previously taken HCV medication
- Liver Cirrhosis
- Evidence of decompensated liver disease
- HIV/ hepatitis B virus (HBV) coinfection
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
Canada6 sites
Local Institution
Calgary, Alberta, T2N 4Z6
Local Institution
Edmonton, Alberta, T6G 2S2
Local Institution
Toronto, Ontario, M5G 2C4
Local Institution
Vancouver, British Columbia, V5Z 1H2
Local Institution
Vancouver, British Columbia, V6Z 2K5
Local Institution
Victoria, British Columbia, V8V 3P9
France6 sites
Local Institution
Créteil, 94010
Local Institution
Limoges, 87042
Local Institution
Montpellier, 34295
Local Institution
Paris, 75679
Local Institution
Pessac, 33604
Local Institution
Vandœuvre-lès-Nancy, 54511
About this study
Official title: A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-Cirrhotic Subjects Infected With Chronic HCV Genotype 3
The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.
- Conditions
- Hepatitis C
- Being tested
- Daclatasvir, Sofosbuvir, Ribavirin
- 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
RibavirinDrug
| Study group | Role | What they receive |
|---|---|---|
| Daclatasvir + Sofosbuvir | Active comparator | Daclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks Receives: Drug: Daclatasvir; Drug: Sofosbuvir |
| Daclatasvir + Sofosbuvir + Ribavirin | Active comparator | Daclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm once daily for 8 weeks Receives: Drug: Daclatasvir; Drug: Sofosbuvir; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF)
SVR12 defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects treated with 8 weeks of DCV+SOF therapy or DCV+SOF+RBV therapy
Measured: Post Treatment Follow up Week 12
Secondary outcomes (3)
Safety measured by number of incidence of deaths, serious adverse events (SAE)s, discontinuation due to adverse events (AE)s, Grade 3/4 AEs and Grade 3/4 laboratory abnormalities observed from clinical laboratory testing
Measured: Approximately 1.5 years
Antiviral activity measured by the proportion of subjects who achieve HCV RNA < lower limit of quantification (LLOQ) - at during and after treatment in each treatment arm
Measured: Post treatment follow up Week 24
Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm
Measured: Post Treatment Follow up Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startDec 2015
- Primary completionJun 2016 (estimated)
- Study completionJun 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
- Randomised
- Intervention model
- Parallel groups
- 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
- NCT02551861
- Sponsor's protocol ID
- AI444-377
- Other IDs
- 2015-003468-36, 2015
- Status last verified
- Jan 2016
- First submitted
- 15 Sep 2015
- Last updated
- 15 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-Cirrhotic Subjects Infected With Chronic HCV Genotype 3
- ClinicalTrials.gov ID
- NCT02551861
- Acronym / sponsor ID
- AI444-377
- 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
- Jun 2017 (estimated)
- First posted
- 16 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 this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daclatasvir + Sofosbuvir | Active comparator | Drug: Daclatasvir, Drug: SofosbuvirDaclatasvir 60mg tablet and Sofosbuvir 400mg tablet oral dosing once daily for 8 weeks |
| Daclatasvir + Sofosbuvir + Ribavirin | Active comparator | Drug: Daclatasvir, Drug: Sofosbuvir, Drug: RibavirinDaclatasvir 60mg tablet + Sofosbuvir 400mg tablet+ Ribavirin 1000-1200mg tablet(weight based dosing) oral dosing split into am and pm 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 (5 listed)
- Genotype 3
- HCV RNA < 2000000 IU/mL
- Never taken HCV medication
- Absence of advanced fibrosis or cirrhosis
- Body mass index (BMI) 18-40 kg/m^2
Key exclusion criteria (5 listed)
- Infection with HCV other than genotype 3 (GT3); Mixed infections of any genotype
- Previously taken HCV medication
- Liver Cirrhosis
- Evidence of decompensated liver disease
- HIV/ hepatitis B virus (HBV) coinfection
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, Daclatasvir + Sofosbuvir + Ribavirin |
| Sofosbuvir | Drug | Daclatasvir + Sofosbuvir, Daclatasvir + Sofosbuvir + Ribavirin |
| Ribavirin | Drug | Daclatasvir + Sofosbuvir + Ribavirin |
Primary outcome
Proportion of subjects with sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF)
Time frame: Post Treatment Follow up Week 12
SVR12 defined as HCV RNA < LLOQ target detected (TD) or target not detected (TND) at follow-up Week 12 in subjects treated with 8 weeks of DCV+SOF therapy or DCV+SOF+RBV therapy
3 secondary outcomes
Safety measured by number of incidence of deaths, serious adverse events (SAE)s, discontinuation due to adverse events (AE)s, Grade 3/4 AEs and Grade 3/4 laboratory abnormalities observed from clinical laboratory testing
Time frame: Approximately 1.5 years
Antiviral activity measured by the proportion of subjects who achieve HCV RNA < lower limit of quantification (LLOQ) - at during and after treatment in each treatment arm
Time frame: Post treatment follow up Week 24
Proportion of subjects with CC, CT or TT IL28B genotype who achieve SVR12 in each treatment arm
Time frame: Post Treatment Follow up Week 12
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 15 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
12 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, Sofosbuvir and Ribavirin in people with Hepatitis C, run by Bristol-Myers Squibb at 12 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 5 inclusion and 5 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 15 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 12 sites in Canada, France. 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 sustained virologic response (SVR12) treated with Daclatasvir + Sofosbuvir (DCV+SOF) (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 15 Jan 2016.