Hepatitis C Virus (HCV)Phase 3NCT02487199
Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Kidney Impairment or End Stage Kidney Disease
A Phase 3 study testing ombitasvir/paritaprevir/ritonavir and dasabuvir and ombitasvir/paritaprevir/ritonavir in people with Hepatitis C Virus (HCV), run by AbbVie.
Trial summary
This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus (HCV)
- What is being tested?
- ombitasvir/paritaprevir/ritonavir and dasabuvir and ombitasvir/paritaprevir/ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2015to 5 Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hepatitis C virus (HCV) genotype 1a (GT1a) infection or genotype 4 (GT4) infection (HCV RNA level greater than 1,000 IU/mL at Screening).
- Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control.
- Chronic kidney disease stage 4 or stage 5.
Who cannot join
- Females who are pregnant or breastfeeding
- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
- HCV genotype performed during screening unable to genotype or co-infection with any other HCV genotype, no mixed genotypes.
- Abnormal laboratory tests
- Current enrollment in another investigational study
- Prior treatment with a direct acting antiviral agent (DAA) containing regimen with the exception of interferon or pegylated interferon with or without ribavirin
- Current treatment with a direct acting antiviral agent (DAA) containing regimen
- Any evidence of liver cirrhosis or liver cancer
About this study
Official title: An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-II)
This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.
- Conditions
- Hepatitis C Virus (HCV)
- Being tested
- ombitasvir/paritaprevir/ritonavir and dasabuvir, ombitasvir/paritaprevir/ritonavir
- Keywords
- hepatitis C infection, hepatitis C, severe kidney disease, chronic kidney disease, Genotype 1a, Genotype 4, treatment experienced, interferon, IFN, pegIFN
- Medical subject headings
- Hepatitis C, Kidney Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ombitasvir/paritaprevir/ritonavir and dasabuvirDrug
Also called Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333
Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
ombitasvir/paritaprevir/ritonavirDrug
Also called Technivie, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267
Tablet; ombitasvir coformulated with paritaprevir and ritonavir
| Study group | Role | What they receive |
|---|---|---|
| HCV GT1a (3-DAA) | Experimental | Participants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir and dasabuvir |
| HCV GT4 (2-DAA) | Experimental | Participants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks. Receives: Drug: ombitasvir/paritaprevir/ritonavir |
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 Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.
Measured: 12 weeks after the last actual dose of study drug
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity from first dose of study drug until 30 days after the last dose. For more details on AEs please see the Adverse Event section.
Measured: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks)
Secondary outcomes (2)
Percentage of Participants With On-treatment Virologic Failure
On-treatment virologic failure was defined as confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment or confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment with at least 6 weeks of treatment.
Measured: 12 weeks
Percentage of Participants With Post-treatment Relapse
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment.
Measured: From the end of treatment through 12 weeks after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study start30 Sep 2015
- Primary completion5 Dec 2016
- Study completion5 Dec 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C Virus (HCV)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02487199
- Sponsor's protocol ID
- M15-461
- Other IDs
- 2015-002012-33, 2015
- Status last verified
- Oct 2017
- First submitted
- 29 Jun 2015
- Last updated
- 4 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Shuster DL, Menon RM, Ding B, Khatri A, Li H, Cohen E, Jewett M, Cohen DE, Zha J. Effects of chronic kidney disease stage 4, end-stage renal disease, or dialysis on the plasma concentrations of ombitasvir, paritaprevir, ritonavir, and dasabuvir in patients with chronic HCV infection: pharmacokinetic analysis of the phase 3 RUBY-I and RUBY-II trials. Eur J Clin Pharmacol. 2019 Feb;75(2):207-216. doi: 10.1007/s00228-018-2566-6. Epub 2018 Oct 5.
PubMed 30291369
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir With or Without Dasabuvir in Adults With Genotype 1a or Genotype 4 Chronic Hepatitis C Virus (HCV) Infection, With Severe Renal Impairment or End-Stage Renal Disease (RUBY-II)
- ClinicalTrials.gov ID
- NCT02487199
- Acronym / sponsor ID
- M15-461
- Conditions
- Hepatitis C Virus (HCV)
- Keywords
- hepatitis C infection, hepatitis C, severe kidney disease, chronic kidney disease, Genotype 1a, Genotype 4, treatment experienced, interferon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2015 (actual)
- Primary completion
- 5 Dec 2016 (actual)
- Study completion
- 5 Dec 2016 (actual)
- First posted
- 1 Jul 2015 (estimated)
- Results
- Posted 4 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy and safety of ombitasvir/paritaprevir/ritonavir with or without dasabuvir in adults with hepatitis C virus (HCV) genotype 1a (GT1a) or genotype 4 (GT4) infection and with severe kidney impairment or end-stage kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV GT1a (3-DAA) | Experimental | Drug: ombitasvir/paritaprevir/ritonavir and dasabuvirParticipants with hepatitis C virus (HCV) genotype 1a (GT1a) infection received 3-direct-acting antiviral agent (3-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily] and dasabuvir [250 mg twice daily]) for 12 weeks. |
| HCV GT4 (2-DAA) | Experimental | Drug: ombitasvir/paritaprevir/ritonavirParticipants with hepatitis C virus (HCV) genotype 4 (GT4) infection received 2-direct-acting antiviral agent (2-DAA: ombitasvir/paritaprevir/ritonavir [25 mg/150 mg/100 mg once daily]) for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic hepatitis C virus (HCV) genotype 1a (GT1a) infection or genotype 4 (GT4) infection (HCV RNA level greater than 1,000 IU/mL at Screening).
- Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control.
- Chronic kidney disease stage 4 or stage 5.
Key exclusion criteria (8 listed)
- Females who are pregnant or breastfeeding
- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab)
- HCV genotype performed during screening unable to genotype or co-infection with any other HCV genotype, no mixed genotypes.
- Abnormal laboratory tests
- Current enrollment in another investigational study
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 and dasabuvirAlso: Viekira Pak, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267, dasabuvir also known as ABT-333Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet | Drug | HCV GT1a (3-DAA) |
| ombitasvir/paritaprevir/ritonavirAlso: Technivie, paritaprevir also known as ABT-450, ombitasvir also known as ABT-267Tablet; ombitasvir coformulated with paritaprevir and ritonavir | Drug | HCV GT4 (2-DAA) |
Primary outcome
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Time frame: 12 weeks after the last actual dose of study drug
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (<LLOQ) 12 weeks after the last dose of study drug. Participants with missing data after backward imputation were imputed as nonresponders.
Number of Participants With Adverse Events
Time frame: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either reasonable possibility or no reasonable possibility. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity from first dose of study drug until 30 days after the last dose. For more details on AEs please see the Adverse Event section.
2 secondary outcomes
Percentage of Participants With On-treatment Virologic Failure
Time frame: 12 weeks
Percentage of Participants With Post-treatment Relapse
Time frame: From the end of treatment through 12 weeks after the last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30291369Shuster DL, Menon RM, Ding B, Khatri A, Li H, Cohen E, Jewett M, Cohen DE, Zha J. Effects of chronic kidney disease stage 4, end-stage renal disease, or dialysis on the plasma concentrations of ombitasvir, paritaprevir, ritonavir, and dasabuvir in patients with chronic HCV infection: pharmacokinetic analysis of the phase 3 RUBY-I and RUBY-II trials. Eur J Clin Pharmacol. 2019 Feb;75(2):207-216. doi: 10.1007/s00228-018-2566-6. Epub 2018 Oct 5.
- Related InfoLink provided by the sponsor.
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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.
AbbVie Inc study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ombitasvir/paritaprevir/ritonavir and dasabuvir and ombitasvir/paritaprevir/ritonavir in people with Hepatitis C Virus (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 3 inclusion and 8 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 4 Dec 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 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 4 Dec 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?
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) (time frame: 12 weeks after the last actual dose of study drug). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02487199, which also lists 1 linked publication.
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 4 Dec 2017.