Chronic Hepatitis CPhase 2NCT02493855
Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults
A Phase 2 study testing Ombitasvir/ABT-450/Ritonavir, Dasabuvir and Ribavirin (RBV) in people with Chronic Hepatitis C and Hepatitis C (HCV), run by AbbVie.
Trial summary
To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1a
- What is being tested?
- Ombitasvir/ABT-450/Ritonavir, Dasabuvir and Ribavirin (RBV)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Dec 2016
- Phase
- Phase 2
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screening laboratory result indicating HCV genotype 1 (GT1) a infection.
- Chronic HCV infection.
- Subjects must be non-cirrhotic.
- Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (IRB) approved informed consent.
Who cannot join
- Women who are pregnant or breastfeeding.
- Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
- Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.
- Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegylated interferon (pegIFN), ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or nonstructural viral protein 5A (NS5A) inhibitors.
- History or solid organ transplant.
- Screening laboratory analysis that shows abnormal results.
About this study
Official title: An Exploratory Study to Evaluate the Kinetics of Viral Load Decline With Ombitasvir/ABT 450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection
To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.
- Being tested
- Ombitasvir/ABT-450/Ritonavir, Dasabuvir, Ribavirin (RBV)
- Keywords
- Treatment naive, HCV, Interferon free, Hepatitis C Genotype 1a, Chronic Hepatitis C, Hepatitis C
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ombitasvir/ABT-450/RitonavirDrug
Also called ABT-267/ABT-450/ritonavir
Ombitasvir/ABT-450/ritonavir combination tablets
DasabuvirDrug
Also called ABT-333
Dasabuvir tablets
Ribavirin (RBV)Drug
Ribavirin tablets
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Ribavirin Full Dose for Last 10 Weeks | Experimental | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks. Receives: Drug: Ombitasvir/ABT-450/Ritonavir; Drug: Dasabuvir; Drug: Ribavirin (RBV) |
| Arm B: Ribavirin Full Dose for 12 Weeks | Experimental | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks. Receives: Drug: Ombitasvir/ABT-450/Ritonavir; Drug: Dasabuvir; Drug: Ribavirin (RBV) |
| Arm C: Ribavirin Low-dose for 12 Weeks | Experimental | Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks. Receives: Drug: Ombitasvir/ABT-450/Ritonavir; Drug: Dasabuvir; Drug: Ribavirin (RBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment
HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm.
Measured: From Week 0 to Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016
- Study completionDec 2016
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 CStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emily Dumas, PhD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02493855
- Sponsor's protocol ID
- M14-242
- Other IDs
- 2014-001478-32, 2014
- Status last verified
- Sep 2017
- First submitted
- 2 Jul 2015
- Last updated
- 31 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate the Kinetics of Viral Load Decline With Ombitasvir/ABT 450/Ritonavir (Ombitasvir/ABT-450/r) and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naïve Adults With Genotype 1a Chronic Hepatitis C Virus (HCV) Infection
- ClinicalTrials.gov ID
- NCT02493855
- Acronym / sponsor ID
- M14-242
- Keywords
- Treatment naive, HCV, Interferon free, Hepatitis C Genotype 1a, Chronic Hepatitis C, Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Jun 2015 (actual)
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jul 2015 (estimated)
- Results
- Posted 15 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the effect of ribavirin on second phase plasma hepatitis C virus (HCV) ribonucleic acid (RNA) decline in participants who receive ombitasvir/ABT-450/ritonavir and dasabuvir with full dose ribavirin, low dose ribavirin or without ribavirin for 2 weeks in treatment-naive HCV genotype (GT) 1a-infected adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: Ribavirin Full Dose for Last 10 Weeks | Experimental | Drug: Ombitasvir/ABT-450/Ritonavir, Drug: Dasabuvir, Drug: Ribavirin (RBV)Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks. |
| Arm B: Ribavirin Full Dose for 12 Weeks | Experimental | Drug: Ombitasvir/ABT-450/Ritonavir, Drug: Dasabuvir, Drug: Ribavirin (RBV)Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks. |
| Arm C: Ribavirin Low-dose for 12 Weeks | Experimental | Drug: Ombitasvir/ABT-450/Ritonavir, Drug: Dasabuvir, Drug: Ribavirin (RBV)Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Screening laboratory result indicating HCV genotype 1 (GT1) a infection.
- Chronic HCV infection.
- Subjects must be non-cirrhotic.
- Subjects must be able to understand and adhere to the study visit schedule and all protocol requirements as well as voluntarily sign and date an institutional review board (IRB) approved informed consent.
Key exclusion criteria (6 listed)
- Women who are pregnant or breastfeeding.
- Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab) positive immunoassay.
- Clinically significant abnormalities or co-morbidities, other than HCV infection, that make the subject unsuitable for this study or treatment.
- Current enrollment in another interventional clinical study. Previous use of any HCV treatments including pegylated interferon (pegIFN), ribavirin, or any direct acting antiviral agent, either investigational or approved, for HCV including protease inhibitors, nucleoside or non-nucleoside polymerase inhibitors, or nonstructural viral protein 5A (NS5A) inhibitors.
- History or solid organ transplant.
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/ABT-450/RitonavirAlso: ABT-267/ABT-450/ritonavirOmbitasvir/ABT-450/ritonavir combination tablets | Drug | Arm A: Ribavirin Full Dose for Last 10 Weeks, Arm B: Ribavirin Full Dose for 12 Weeks, Arm C: Ribavirin Low-dose for 12 Weeks |
| DasabuvirAlso: ABT-333Dasabuvir tablets | Drug | Arm A: Ribavirin Full Dose for Last 10 Weeks, Arm B: Ribavirin Full Dose for 12 Weeks, Arm C: Ribavirin Low-dose for 12 Weeks |
| Ribavirin (RBV)Ribavirin tablets | Drug | Arm A: Ribavirin Full Dose for Last 10 Weeks, Arm B: Ribavirin Full Dose for 12 Weeks, Arm C: Ribavirin Low-dose for 12 Weeks |
Primary outcome
Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment
Time frame: From Week 0 to Week 2
HCV viral kinetics in plasma during therapy were modeled through non-linear mixed effect models, including a rapid first phase of initial decline and a slower second phase decline. The slope of the second phase decline was estimated for each treatment arm.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- 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.
Emily Dumas, PhD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ombitasvir/ABT-450/Ritonavir, Dasabuvir and Ribavirin (RBV) in people with Chronic Hepatitis C and Hepatitis C (HCV), 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 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: finished, as of the sponsor's last update on 31 Oct 2017. 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 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?
Yes. Results are posted in the registry (first posted 15 May 2017). 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?
Slope of the Second Phase Decline in Plasma HCV Ribonucleic Acid (RNA) Levels During Treatment (time frame: From Week 0 to Week 2). 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 31 Oct 2017.