Chronic Hepatitis C Virus (HCV Infection Genotype 1)Phase 3NCT02399345
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir Co-Administered With Sofosbuvir With and Without Ribavirin in Treatment-Naive HCV Genotype 1-Infected Adults
A Phase 3 study testing ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir (SOF) and ribavirin (RBV) in people with Chronic Hepatitis C Virus (HCV Infection Genotype 1), run by AbbVie.
Trial summary
This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Hepatitis C Virus (HCV Infection Genotype 1)
- What is being tested?
- ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir (SOF) and ribavirin (RBV)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Nov 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 18 years of age at time of screening
- Chronic Hepatitis C virus (HCV) infection prior to study enrollment
- Screening laboratory results from the central clinical laboratory indicating HCV genotype 1 infection only
- Absence of cirrhosis and advanced bridging fibrosis
Who cannot join
- Positive test result for hepatitis B surface antigen (HbsAg) or human immunodeficiency virus (HIV) positive immunoassay
- Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject an unsuitable candidate for this study or treatment with Ribavirin (RBV) in the opinion of the investigator
- Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis or advanced bridging fibrosis, e.g., a Metavir score > 2 or an Ishak score > 3
- Use of medications contraindicated for ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir, or ribavirin (RBV; for those that receive RBV), within 2 weeks or 10 half-lives whichever is longer, prior to study drug administration
- Current enrolment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV agents
About this study
Official title: An Open-Label, Treatment Duration-Ranging Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/ Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Naive Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis
- Being tested
- ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir (SOF), ribavirin (RBV)
- Keywords
- Treatment naive, Hepatitis C Genotype 1
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ombitasvir/paritaprevir/ritonavir, dasabuvirDrug
Also called Viekira PAK, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450, dasabuvir also known as ABT-333
tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
sofosbuvir (SOF)Drug
tablet
ribavirin (RBV)Drug
tablet
| Study group | Role | What they receive |
|---|---|---|
| Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV | Experimental | Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir, dasabuvir; Drug: sofosbuvir (SOF); Drug: ribavirin (RBV) |
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 Weeks (SVR12) Post-treatment
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
Measured: 12 weeks after the last actual dose of study drug
Secondary outcomes (2)
Percentage of Subjects With On-treatment Virologic Failure
Virologic failure during treatment was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment; confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir) during treatment; or failure to suppress during treatment (defined as all values of HCV RNA ≥ LLOQ during treatment).
Measured: 6 weeks
Percentage of Subjects With Post-treatment Relapse
Percentage of subjects with HCV RNA less than the lower limit of quantification at the end of treatment with confirmed HCV RNA greater than or equal to the lower limit of quantification through 12 weeks post treatment
Measured: Up to 12 weeks after last actual dose of active study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionNov 2015
- Study completionNov 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 Chronic Hepatitis C Virus (HCV Infection Genotype 1)Studies of the same condition, open and under way.
- More trials run by AbbVieThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Cohen, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399345
- Sponsor's protocol ID
- M15-310
- Other IDs
- 2014-005280-32, 2014
- Status last verified
- Oct 2016
- First submitted
- 23 Mar 2015
- Last updated
- 12 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Treatment Duration-Ranging Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/ Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Co-administered With Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Direct-Acting Antiviral Agent (DAA) Treatment-Naive Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
- ClinicalTrials.gov ID
- NCT02399345
- Acronym / sponsor ID
- M15-310
- Keywords
- Treatment naive, Hepatitis C Genotype 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Posted 12 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label study will evaluate the safety and efficacy of co-formulated ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with sofosbuvir with or without ribavirin administered for either 4 or 6 weeks in treatment naive adults with chronic HCV-genotype 1 infection without cirrhosis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV | Experimental | Drug: ombitasvir/paritaprevir/ritonavir, dasabuvir, Drug: sofosbuvir (SOF), Drug: ribavirin (RBV)Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female at least 18 years of age at time of screening
- Chronic Hepatitis C virus (HCV) infection prior to study enrollment
- Screening laboratory results from the central clinical laboratory indicating HCV genotype 1 infection only
- Absence of cirrhosis and advanced bridging fibrosis
Key exclusion criteria (5 listed)
- Positive test result for hepatitis B surface antigen (HbsAg) or human immunodeficiency virus (HIV) positive immunoassay
- Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject an unsuitable candidate for this study or treatment with Ribavirin (RBV) in the opinion of the investigator
- Any current or past clinical evidence of cirrhosis such as ascites or esophageal varices, or prior biopsy showing cirrhosis or advanced bridging fibrosis, e.g., a Metavir score > 2 or an Ishak score > 3
- Use of medications contraindicated for ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir, or ribavirin (RBV; for those that receive RBV), within 2 weeks or 10 half-lives whichever is longer, prior to study drug administration
- Current enrolment in another clinical study, previous enrolment in this study, or previous use of any investigational or commercially available anti-HCV agents
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 |
|---|---|---|
| ombitasvir/paritaprevir/ritonavir, dasabuvirAlso: Viekira PAK, ombitasvir also known as ABT-267, paritaprevir also known as ABT-450, dasabuvir also known as ABT-333tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet | Drug | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV |
| sofosbuvir (SOF)tablet | Drug | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV |
| ribavirin (RBV)tablet | Drug | Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF plus RBV |
Primary outcome
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
Time frame: 12 weeks after the last actual dose of study drug
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
2 secondary outcomes
Percentage of Subjects With On-treatment Virologic Failure
Time frame: 6 weeks
Percentage of Subjects With Post-treatment Relapse
Time frame: Up to 12 weeks after last actual dose of active study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related info.Link provided by the sponsor.
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.
Eric Cohen, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ombitasvir/paritaprevir/ritonavir, dasabuvir, sofosbuvir (SOF) and ribavirin (RBV) in people with Chronic Hepatitis C Virus (HCV Infection Genotype 1), run by AbbVie.
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 4 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: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 12 Dec 2016). 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 Weeks (SVR12) Post-treatment (time frame: 12 weeks after the last actual dose of study drug). 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 12 Dec 2016.