Chronic Hepatitis C Virus (HCV) InfectionPhase 3Turquoise-IVNCT02216422
A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection
A Phase 3 study testing Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir and Ribavirin (RBV) in people with Chronic Hepatitis C Virus (HCV) Infection, run by AbbVie.
Trial summary
This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C Virus (HCV) Infection
- What is being tested?
- Ombitasvir/Paritaprevir/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
- 36 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Dec 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 hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening)
- Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening
- Participant had never received antiviral treatment (including pegIFN/RBV) for hepatitis C infection (treatment-naïve participant) or had documentation of meeting one of the defined categories of a treatment-experienced participants
- Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3 months prior to screening or a negative ultrasound at screening.
- Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
- Males must have been surgically sterile, or agreed to practice 2 effective methods of birth control throughout the course of the study.
Who cannot join
- Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
- Evidence of current or past Child-Pugh B or C classification
- Confirmed presence of hepatocellular carcinoma
- Abnormal laboratory tests
- Participant who self-reported on average drinking more than 2 drinks per day for current drinkers
- Previous treatment with a direct acting antiviral agent (DAA) containing regimen
- History of solid organ transplant.
About this study
Official title: An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (Turquoise-IV)
This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults.
Read the detailed description
The primary objective of this study was to assess the safety and efficacy (the percentage of participants achieving a 12-week sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment]) of co-formulated ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/r) and dasabuvir co-administered with RBV for 12 weeks in HCV genotype 1b-infected adult participants with compensated cirrhosis. The secondary objectives of this study were to assess the number and percentage of participants with virologic failure during treatment and the percentage of participants with relapse post-treatment.
- Being tested
- Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir, Ribavirin (RBV)
- Keywords
- Chronic Hepatitis C, Hepatitis C, Hepatitis C Virus, Hepatitis C Genotype 1b, Interferon-Free
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Infections
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
Ribavirin (RBV)Drug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV | Experimental | Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks Receives: Drug: Ombitasvir/Paritaprevir/Ritonavir; Drug: Dasabuvir; 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
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. Participants with missing data were imputed as failures.
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 posted15 Aug 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 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) 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rolando M Viani, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216422
- Sponsor's protocol ID
- M14-252
- Acronym
- Turquoise-IV
- Status last verified
- May 2016
- First submitted
- 12 Aug 2014
- Last updated
- 29 Jun 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 29 Jun 2016. 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 ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (Turquoise-IV)
- ClinicalTrials.gov ID
- NCT02216422
- Acronym / sponsor ID
- Turquoise-IV / M14-252
- Keywords
- Chronic Hepatitis C, Hepatitis C, Hepatitis C Virus, Hepatitis C Genotype 1b, Interferon-Free
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 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.
This was a multicenter study evaluating the efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir co-administered with ribavirin (RBV) for 12 weeks in treatment naïve and pegylated-interferon alfa-2a or alfa-2b (pegIFN)/RBV treatment-experienced, cirrhotic HCV genotype 1b-infected adults.
Detailed description
The primary objective of this study was to assess the safety and efficacy (the percentage of participants achieving a 12-week sustained virologic response (SVR12), [HCV ribonucleic acid (RNA) < lower limit of quantification (LLOQ) 12 weeks following treatment]) of co-formulated ombitasvir, paritaprevir, and ritonavir (ombitasvir/paritaprevir/r) and dasabuvir co-administered with RBV for 12 weeks in HCV genotype 1b-infected adult participants with compensated cirrhosis. The secondary objectives of this study were to assess the number and percentage of participants with virologic failure during treatment and the percentage of participants with relapse post-treatment.
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 with RBV | Experimental | Drug: Ombitasvir/Paritaprevir/Ritonavir, Drug: Dasabuvir, Drug: Ribavirin (RBV)Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice 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 (6 listed)
- Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than 1,000 IU/mL at Screening)
- Evidence of liver cirrhosis as confirmed by liver biopsy or Fibroscan with Child-Pugh score less than or equal to 6 at Screening
- Participant had never received antiviral treatment (including pegIFN/RBV) for hepatitis C infection (treatment-naïve participant) or had documentation of meeting one of the defined categories of a treatment-experienced participants
- Absence of hepatocellular carcinoma (HCC) as indicated by a negative ultrasound, computed tomography (CT) scan, or magnetic resonance imaging (MRI) performed within 3 months prior to screening or a negative ultrasound at screening.
- Females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control
Key exclusion criteria (7 listed)
- Positive screen for hepatitis B Surface antigen or anti-Human Immunodeficiency virus antibody
- Evidence of current or past Child-Pugh B or C classification
- Confirmed presence of hepatocellular carcinoma
- Abnormal laboratory tests
- Participant who self-reported on average drinking more than 2 drinks per day for current drinkers
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 with RBV |
| DasabuvirAlso: ABT-333Tablet | Drug | Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV |
| Ribavirin (RBV)Tablet | Drug | Ombitasvir/Paritaprevir/Ritonavir plus Dasabuvir with RBV |
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. Participants with missing data were imputed as failures.
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 29 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Rolando M Viani, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir and Ribavirin (RBV) in people with Chronic Hepatitis C Virus (HCV) Infection, 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 6 inclusion and 7 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 29 Jun 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 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?
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 29 Jun 2016.