Chronic Hepatitis C InfectionPhase 3TURQUOISE-IIINCT02219503
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis
A Phase 3 study testing Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in people with Chronic Hepatitis C Infection and Compensated Cirrhosis, run by AbbVie.
Trial summary
The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C Infection, Compensated Cirrhosis
- What is being tested?
- Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is defined as the following:
- Positive for anti-HCV antibody (Ab) or HCV RNA > 1,000 IU/mL at least 6 months before Screening, and positive for HCV RNA and anti-HCV Ab at the time of Screening; or
- HCV RNA > 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease).
- Screening laboratory result indicating HCV genotype 1b-infection.
- Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.
Who cannot join
- Women who are pregnant or breastfeeding.
- Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).
- Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
- Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI.)
- Use of contraindicated medications within 2 weeks of dosing
- Screening laboratory analyses showing any of the following abnormal laboratory results:
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- Calculated creatinine clearance (using Cockcroft-Gault method) < 30 mL/min
- Albumin < 2.8 g/dL
- International normalized ratio (INR) > 1.8. Participants with a known inherited blood disorder and INR > 1.8 may be enrolled with permission of the AbbVie Study Designated Physician.
- Hemoglobin < 10 g/dL
- Platelets < 25,000 cells per mm3
- Total bilirubin > 3.0 mg/dL
About this study
Official title: An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)
The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.
Read the detailed description
This was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV) treatment-experienced adults with compensated cirrhosis. The duration of the study was up to 36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week Treatment Period and a 24-week Post-Treatment Period for all participants who received study drugs.
- Being tested
- Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir
- Keywords
- Hepatitis C, Chronic Hepatitis C, Compensated Cirrhosis, Cirrhotic, Hepatitis C Genotype 1b, Hepatitis C Virus, Interferon-Free, Child Pugh A, Ribavirin-Free
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
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 also known as ombitasvir, ABT-450 also known as paritaprevir, Ritonavir also known as norvir
Tablet; paritaprevir co-formulated with ritonavir and ombitasvir
DasabuvirDrug
Also called ABT-333
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir | Experimental | Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks Receives: Drug: Ombitasvir/Paritaprevir/Ritonavir; Drug: Dasabuvir |
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
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug.
The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.
Measured: Post-treatment Day 1 to Post-treatment Week 12
Secondary outcomes (2)
Percentage of Participants With On-Treatment Virologic Failure
On-Treatment Virologic Failure is defined as confirmed HCV RNA >= LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir (local minimum value) in HCV RNA [2 consecutive HCV RNA measurements > 1 log10 IU/mL above nadir] at any time point during treatment, or failure to suppress during treatment [all on-treatment values of HCV RNA >= LLOQ] with at least 6 weeks [defined as active study drug duration ≥ 36 days] of treatment.
Measured: Day 1 through Week 12
Percentage of Participants With Post-Treatment Relapse
Post- Treatment Relapse is defined as confirmed HCV RNA >= LLOQ between end of treatment and 12 weeks after last actual dose of active study drug [up to and including the SVR12 assessment time point] for a participant with HCV RNA < LLOQ at Final Treatment Visit who completes treatment.
Measured: Post-treatment Day 1 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 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionJun 2015
- Study completionSep 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis C InfectionStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roger Trinh, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219503
- Sponsor's protocol ID
- M14-490
- Other IDs
- 2014-001953-18, 2014
- Acronym
- TURQUOISE-III
- Status last verified
- Jul 2021
- First submitted
- 15 Aug 2014
- Last updated
- 12 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, Elkhashab M, Bernstein DE, Younes Z, Reindollar RW, Larsen L, Fu B, Howieson K, Polepally AR, Pangerl A, Shulman NS, Poordad F. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. J Hepatol. 2016 Feb;64(2):301-307. doi: 10.1016/j.jhep.2015.10.005. Epub 2015 Oct 22.
PubMed 26476290
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-III)
- ClinicalTrials.gov ID
- NCT02219503
- Acronym / sponsor ID
- TURQUOISE-III / M14-490
- Keywords
- Hepatitis C, Chronic Hepatitis C, Compensated Cirrhosis, Cirrhotic, Hepatitis C Genotype 1b, Hepatitis C Virus, Interferon-Free, Child Pugh A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Aug 2014 (estimated)
- Results
- Posted 29 Jun 2016
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 was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.
Detailed description
This was a multicenter study evaluating the efficacy and safety of ombitasvir/ paritaprevir/ritonavir and dasabuvir administered for 12 weeks in HCV genotype 1b (GT1b)-infected, treatment-naïve and previous pegylated interferon (pegIFN)/ ribavirin (RBV) treatment-experienced adults with compensated cirrhosis. The duration of the study was up to 36 weeks (not including a screening period of up to 42 days) and consisted of a 12-week Treatment Period and a 24-week Post-Treatment Period for all participants who received study drugs.
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 plus Dasabuvir | Experimental | Drug: Ombitasvir/Paritaprevir/Ritonavir, Drug: DasabuvirOmbitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered 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 (5 listed)
- Chronic HCV genotype 1-infection prior to study enrollment. Chronic HCV-infection is defined as the following:
- Screening laboratory result indicating HCV genotype 1b-infection.
- Compensated cirrhosis defined as a Child-Pugh Score of 5 or 6 at Screening.
Key exclusion criteria (12 listed)
- Women who are pregnant or breastfeeding.
- Positive test result for Hepatitis B surface antigen (HBsAg) or positive human immunodeficiency virus (HIV) antibody (confirmed by Western Blot).
- Any current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation such as ascites (noted on physical exam), variceal bleeding, or hepatic encephalopathy.
- Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to Screening or on an ultrasound performed at Screening (a positive ultrasound result will be confirmed with CT scan or MRI.)
- Use of contraindicated medications within 2 weeks of dosing
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 also known as ombitasvir, ABT-450 also known as paritaprevir, Ritonavir also known as norvirTablet; paritaprevir co-formulated with ritonavir and ombitasvir | Drug | Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir |
| DasabuvirAlso: ABT-333Tablet | Drug | Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir |
Primary outcome
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
Time frame: Post-treatment Day 1 to Post-treatment Week 12
Sustained Virologic Response 12 (SVR12) is defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ; < 25 IU/mL) 12 weeks after the last dose of study drug. The primary efficacy endpoints were non-inferiority and superiority of the percentage of participants who achieved sustained virologic response 12 weeks after treatment in each treatment arm compared with the historical threshold for sofosbuvir and peginterferon (pegIFN)/RBV for the treatment of subjects with HCV GT1b infection and cirrhosis.
2 secondary outcomes
Percentage of Participants With On-Treatment Virologic Failure
Time frame: Day 1 through Week 12
Percentage of Participants With Post-Treatment Relapse
Time frame: Post-treatment Day 1 to Post-treatment Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26476290Feld JJ, Moreno C, Trinh R, Tam E, Bourgeois S, Horsmans Y, Elkhashab M, Bernstein DE, Younes Z, Reindollar RW, Larsen L, Fu B, Howieson K, Polepally AR, Pangerl A, Shulman NS, Poordad F. Sustained virologic response of 100% in HCV genotype 1b patients with cirrhosis receiving ombitasvir/paritaprevir/r and dasabuvir for 12weeks. J Hepatol. 2016 Feb;64(2):301-307. doi: 10.1016/j.jhep.2015.10.005. Epub 2015 Oct 22.
- 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.
Roger Trinh, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in people with Chronic Hepatitis C Infection and Compensated Cirrhosis, 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 12 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 Jul 2021. 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 29 Jun 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: Post-treatment Day 1 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 NCT02219503, 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 12 Jul 2021.