Chronic Hepatitis CPhase 3NCT02476617
Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults
A Phase 3 study testing ombitasvir/paritaprevir/ritonavir, dasabuvir and ribavirin in people with Chronic Hepatitis C and Hepatitis C (HCV), run by AbbVie.
Trial summary
A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with… 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/paritaprevir/ritonavir, dasabuvir and ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Screening laboratory result indicating hepatitis C viral (HCV) genotype (GT) 1a infection.
- Chronic HCV infection.
- Participants must be non-cirrhotic.
- Participants must be treatment-naïve or have documentation that they were adherent to prior pegIFN/RBV combination therapy and meet the criteria of prior pegylated-interferon (pegIFN)/ribavirin (RBV) treatment failure.
- Participants must meet specific human leukocyte antigen (HLA) allele requirements.
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 enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than pegIFN or RBV (including previous exposure to paritaprevir, ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks prior to study drug administration.
- History of solid organ transplant.
- Screening laboratory analysis that shows abnormal results.
About this study
Official title: An Exploratory Study to Evaluate Immune Restoration Following Removal of Viral Antigen in Treatment-Naïve and Treatment-Experienced Adults With Genotype (GT) 1a Chronic Hepatitis C Virus (HCV) Infection Administered Ombitasvir/ ABT-450/Ritonavir With Dasabuvir and Ribavirin (RBV) for 12 Weeks
A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12 weeks.
Read the detailed description
A study to evaluate the role of ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with RBV treatment leading to sustained virologic response 12 weeks post-dosing (SVR12) on the changes from baseline in IFN-stimulated gene (ISG) expression in peripheral blood mononucleated cells (PBMCs) in HCV GT 1a-infected adult participants.
- Being tested
- ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin
- Keywords
- Treatment naive, Interferon free, HCV, Chronic Hepatitis C, Hepatitis C Genotype 1a, Hepatitis C, pegylated-interferon (pegIFN)/ribavirin (RBV) experienced
- 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/paritaprevir/ritonavirDrug
Also called ABT-267/ABT-450/ritonavir
ombitasvir/ABT-450/ritonavir tablets
dasabuvirDrug
Also called ABT-333
dasabuvir tablets
ribavirinDrug
ribavirin tablets
| Study group | Role | What they receive |
|---|---|---|
| Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV | Experimental | Ombitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily [QD]) + dasabuvir (250 mg twice daily [BID]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID) Receives: Drug: ombitasvir/paritaprevir/ritonavir; Drug: dasabuvir; Drug: ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
The changes from week 0 to post-treatment (PT) week 12 in key ISG expression in PBMCs for participants achieving sustained virologic response 12 weeks PT (SVR12) where SVR12 was defined as 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. For each key ISG, fold change was defined as the ratio of the difference between PT Week 12 and baseline expressions over the baseline expression.
Measured: Week 0 to Post-Treatment Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionAug 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT02476617
- Sponsor's protocol ID
- M14-243
- Status last verified
- Aug 2017
- First submitted
- 17 Jun 2015
- Last updated
- 3 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Cui A, Li B, Wallace MS, Gonye ALK, Oetheimer C, Patel H, Tonnerre P, Holmes JA, Lieb D, Yao BS, Ma A, Roberts K, Damasio M, Chen JH, Piou D, Carlton-Smith C, Brown J, Mylvaganam R, Hon Fung JM, Sade-Feldman M, Aneja J, Gustafson J, Epstein ET, Salloum S, Brisac C, Thabet A, Kim AY, Lauer GM, Hacohen N, Chung RT, Alatrakchi N. Single-cell atlas of the liver myeloid compartment before and after cure of chronic viral hepatitis. J Hepatol. 2024 Feb;80(2):251-267. doi: 10.1016/j.jhep.2023.02.040. Epub 2023 Mar 25.
PubMed 36972796Tonnerre P, Wolski D, Subudhi S, Aljabban J, Hoogeveen RC, Damasio M, Drescher HK, Bartsch LM, Tully DC, Sen DR, Bean DJ, Brown J, Torres-Cornejo A, Robidoux M, Kvistad D, Alatrakchi N, Cui A, Lieb D, Cheney JA, Gustafson J, Lewis-Ximenez LL, Massenet-Regad L, Eisenhaure T, Aneja J, Haining WN, Chung RT, Hacohen N, Allen TM, Kim AY, Lauer GM. Differentiation of exhausted CD8+ T cells after termination of chronic antigen stimulation stops short of achieving functional T cell memory. Nat Immunol. 2021 Aug;22(8):1030-1041. doi: 10.1038/s41590-021-00982-6. Epub 2021 Jul 26.
PubMed 34312544
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate Immune Restoration Following Removal of Viral Antigen in Treatment-Naïve and Treatment-Experienced Adults With Genotype (GT) 1a Chronic Hepatitis C Virus (HCV) Infection Administered Ombitasvir/ ABT-450/Ritonavir With Dasabuvir and Ribavirin (RBV) for 12 Weeks
- ClinicalTrials.gov ID
- NCT02476617
- Acronym / sponsor ID
- M14-243
- Keywords
- Treatment naive, Interferon free, HCV, Chronic Hepatitis C, Hepatitis C Genotype 1a, Hepatitis C, pegylated-interferon (pegIFN)/ribavirin (RBV) experienced
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 19 Jun 2015 (estimated)
- Results
- Posted 5 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate immune restoration following removal of viral antigen in non-cirrhotic hepatitis C virus (HCV) genotype (GT) 1a treatment-naïve and pegylated-interferon (pegIFN)/ribavirin (RBV) treatment-experienced adults receiving treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with ribavirin (RBV) for 12 weeks.
Detailed description
A study to evaluate the role of ombitasvir/paritaprevir/ritonavir and dasabuvir coadministered with RBV treatment leading to sustained virologic response 12 weeks post-dosing (SVR12) on the changes from baseline in IFN-stimulated gene (ISG) expression in peripheral blood mononucleated cells (PBMCs) in HCV GT 1a-infected adult participants.
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/ritonavir + dasabuvir + RBV | Experimental | Drug: ombitasvir/paritaprevir/ritonavir, Drug: dasabuvir, Drug: ribavirinOmbitasvir/paritaprevir/ritonavir (25 mg/150 mg/100 mg once daily [QD]) + dasabuvir (250 mg twice daily [BID]) + weight based Ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided BID) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Screening laboratory result indicating hepatitis C viral (HCV) genotype (GT) 1a infection.
- Chronic HCV infection.
- Participants must be non-cirrhotic.
- Participants must be treatment-naïve or have documentation that they were adherent to prior pegIFN/RBV combination therapy and meet the criteria of prior pegylated-interferon (pegIFN)/ribavirin (RBV) treatment failure.
- Participants must meet specific human leukocyte antigen (HLA) allele requirements.
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 enrollment in this study, prior or current use of any investigational or commercially available anti-HCV agents other than pegIFN or RBV (including previous exposure to paritaprevir, ombitasvir, or dasabuvir), or receipt of any investigational product within 6 weeks prior to study drug administration.
- History of 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/paritaprevir/ritonavirAlso: ABT-267/ABT-450/ritonavirombitasvir/ABT-450/ritonavir tablets | Drug | Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV |
| dasabuvirAlso: ABT-333dasabuvir tablets | Drug | Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV |
| ribavirinribavirin tablets | Drug | Ombitasvir/paritaprevir/ritonavir + dasabuvir + RBV |
Primary outcome
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12
Time frame: Week 0 to Post-Treatment Week 12
The changes from week 0 to post-treatment (PT) week 12 in key ISG expression in PBMCs for participants achieving sustained virologic response 12 weeks PT (SVR12) where SVR12 was defined as 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. For each key ISG, fold change was defined as the ratio of the difference between PT Week 12 and baseline expressions over the baseline expression.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36972796Cui A, Li B, Wallace MS, Gonye ALK, Oetheimer C, Patel H, Tonnerre P, Holmes JA, Lieb D, Yao BS, Ma A, Roberts K, Damasio M, Chen JH, Piou D, Carlton-Smith C, Brown J, Mylvaganam R, Hon Fung JM, Sade-Feldman M, Aneja J, Gustafson J, Epstein ET, Salloum S, Brisac C, Thabet A, Kim AY, Lauer GM, Hacohen N, Chung RT, Alatrakchi N. Single-cell atlas of the liver myeloid compartment before and after cure of chronic viral hepatitis. J Hepatol. 2024 Feb;80(2):251-267. doi: 10.1016/j.jhep.2023.02.040. Epub 2023 Mar 25.
- Derived from this study: PubMed 34312544Tonnerre P, Wolski D, Subudhi S, Aljabban J, Hoogeveen RC, Damasio M, Drescher HK, Bartsch LM, Tully DC, Sen DR, Bean DJ, Brown J, Torres-Cornejo A, Robidoux M, Kvistad D, Alatrakchi N, Cui A, Lieb D, Cheney JA, Gustafson J, Lewis-Ximenez LL, Massenet-Regad L, Eisenhaure T, Aneja J, Haining WN, Chung RT, Hacohen N, Allen TM, Kim AY, Lauer GM. Differentiation of exhausted CD8+ T cells after termination of chronic antigen stimulation stops short of achieving functional T cell memory. Nat Immunol. 2021 Aug;22(8):1030-1041. doi: 10.1038/s41590-021-00982-6. Epub 2021 Jul 26.
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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 3 study testing ombitasvir/paritaprevir/ritonavir, dasabuvir and ribavirin 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 5 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 3 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 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 5 Sep 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?
Change in Interferon (IFN)-Stimulated Genes (ISG) Expression in Peripheral Blood Mononucleated Cells (PBMCs) for Participants Achieving SVR12 (time frame: Week 0 to Post-Treatment Week 12). 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 NCT02476617, which also lists 2 linked publications.
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 3 Oct 2017.