Chronic Hepatitis C InfectionPhase 3NCT01716585
A Study to Evaluate Chronic Hepatitis C Infection
A Phase 3 study testing ABT-450/r/ABT-267, ABT-333 and Ribavirin in people with Chronic Hepatitis C Infection, run by AbbVie (prior sponsor, Abbott).
Trial summary
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C Infection
- What is being tested?
- ABT-450/r/ABT-267, ABT-333 and Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 636 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Oct 2014
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control
- Chronic hepatitis C, genotype 1-infection and HCV RNA level greater than 10,000 IU/mL at screening
- Subject has never received antiviral treatment for hepatitis C infection
- No evidence of liver cirrhosis
Who cannot join
- Positive screen for drugs or alcohol
- Significant sensitivity to any drug
- Use of contraindicated medications within 2 weeks of dosing
- Certain predefined abnormal laboratory tests
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)
The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.
- Conditions
- Chronic Hepatitis C Infection
- Being tested
- ABT-450/r/ABT-267, ABT-333, Ribavirin, Placebo for ABT-450/r/ABT-267, Placebo for ABT-333, Placebo for ribavirin
- Keywords
- Hepatitis C Virus, Hepatitis C Genotype 1, Hepatitis C, Treatment-Naïve, Interferon-Free, Chronic Hepatitis C, Viekira Pak, ombitasvir, paritaprevir, dasabuvir
- 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.
ABT-450/r/ABT-267, ABT-333Drug
Also called ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ABT-333 also known as dasabuvir, Viekira PAK
ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
RibavirinDrug
Capsule (double-blind treatment period), tablet (open-label treatment period)
Placebo for ABT-450/r/ABT-267Drug
Tablet
Placebo for ABT-333Drug
Tablet
Placebo for ribavirinDrug
Capsule
| Study group | Role | What they receive |
|---|---|---|
| ABT-450/r/ABT-267 and ABT-333, plus RBV | Experimental | Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks Receives: Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin |
| Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Experimental | Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks Receives: Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin; Drug: Placebo for ABT-450/r/ABT-267; Drug: Placebo for ABT-333; Drug: Placebo for ribavirin |
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 After Treatment
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
Measured: 12 weeks after the last actual dose of active study drug
Secondary outcomes (5)
Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period
Normalization is defined as alanine aminotransferase less than or equal to the upper limit of normal (ULN) at final treatment visit for participants with alanine aminotransferase greater than ULN at baseline.
Measured: At 12 weeks
Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
Measured: 12 weeks after the last actual dose of active study drug
Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
Measured: 12 weeks after the last actual dose of active study drug
Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
Virologic failure was defined as rebound (hepatitis C virus ribonucleic acid [HCV RNA] ≥ lower limit of quantification [LLOQ] after HCV RNA < LLOQ or increase in HCV RNA of at least 1 log10 IU/mL) or failure to suppress (all on-treatment values of plasma HCV RNA ≥ LLOQ with at least 36 days of treatment) during treatment.
Measured: 12 weeks after the last actual dose of active study drug
Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma hepatitis C virus ribonucleic acid (HCV RNA) greater than or equal to the lower limit of quantification (≥ LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.
Measured: Within 12 weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionOct 2013
- Study completionOct 2014
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 (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis C InfectionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 636 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nancy Shulman, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716585
- Sponsor's protocol ID
- M11-646
- Other IDs
- 2012-002019-25
- Status last verified
- Jul 2021
- First submitted
- 18 Oct 2012
- Last updated
- 12 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Feld JJ, Kowdley KV, Coakley E, Sigal S, Nelson DR, Crawford D, Weiland O, Aguilar H, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24;370(17):1594-603. doi: 10.1056/NEJMoa1315722. Epub 2014 Apr 10.
PubMed 24720703Feld JJ, Bernstein DE, Younes Z, Vlierberghe HV, Larsen L, Tatsch F, Ferenci P. Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Liver Int. 2018 Sep;38(9):1571-1575. doi: 10.1111/liv.13708. Epub 2018 Mar 14.
PubMed 29377566Cloherty G, Chevaliez S, Sarrazin C, Herman C, Holzmayer V, Dawson G, Maasoumy B, Vermehren J, Wedemeyer H, Feld JJ, Pawlotsky JM. Hepatitis C RNA assay differences in results: Potential implications for shortened therapy and determination of Sustained Virologic Response. Sci Rep. 2016 Oct 20;6:35410. doi: 10.1038/srep35410.
PubMed 27762283Chevaliez S, Feld J, Cheng K, Wedemeyer H, Sarrazin C, Maasoumy B, Herman C, Hackett J, Cohen D, Dawson G, Pawlotsky JM, Cloherty G. Clinical utility of HCV core antigen detection and quantification in the diagnosis and management of patients with chronic hepatitis C receiving an all-oral, interferon-free regimen. Antivir Ther. 2018;23(3):211-217. doi: 10.3851/IMP3042.
PubMed 27115431
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
- A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-administered With Ribavirin (RBV) in Treatment-Naïve Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (SAPPHIRE-I)
- ClinicalTrials.gov ID
- NCT01716585
- Acronym / sponsor ID
- M11-646
- Conditions
- Chronic Hepatitis C Infection
- Keywords
- Hepatitis C Virus, Hepatitis C Genotype 1, Hepatitis C, Treatment-Naïve, Interferon-Free, Chronic Hepatitis C, Viekira Pak, ombitasvir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 636 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Posted 6 Jan 2015
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 is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ABT-450/r/ABT-267 and ABT-333, plus RBV | Experimental | Drug: ABT-450/r/ABT-267, ABT-333, Drug: RibavirinDouble-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
| Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV | Experimental | Drug: ABT-450/r/ABT-267, ABT-333, Drug: Ribavirin, Drug: Placebo for ABT-450/r/ABT-267, Drug: Placebo for ABT-333, Drug: Placebo for ribavirinDouble-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control
- Chronic hepatitis C, genotype 1-infection and HCV RNA level greater than 10,000 IU/mL at screening
- Subject has never received antiviral treatment for hepatitis C infection
- No evidence of liver cirrhosis
Key exclusion criteria (5 listed)
- Positive screen for drugs or alcohol
- Significant sensitivity to any drug
- Use of contraindicated medications within 2 weeks of dosing
- Certain predefined abnormal laboratory tests
- Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
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 |
|---|---|---|
| ABT-450/r/ABT-267, ABT-333Also: ABT-267 also known as ombitasvir, ABT-450 also known as paritaprevir, ABT-333 also known as dasabuvir, Viekira PAKABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet | Drug | ABT-450/r/ABT-267 and ABT-333, plus RBV, Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV |
| RibavirinCapsule (double-blind treatment period), tablet (open-label treatment period) | Drug | ABT-450/r/ABT-267 and ABT-333, plus RBV, Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV |
| Placebo for ABT-450/r/ABT-267Tablet | Drug | Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV |
| Placebo for ABT-333Tablet | Drug | Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV |
| Placebo for ribavirinCapsule | Drug | Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV |
Primary outcome
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
Time frame: 12 weeks after the last actual dose of active study drug
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
5 secondary outcomes
Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period
Time frame: At 12 weeks
Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
Time frame: 12 weeks after the last actual dose of active study drug
Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
Time frame: 12 weeks after the last actual dose of active study drug
Percentage of Participants With On-treatment Virologic Failure During the Double-blind Treatment Period: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
Time frame: 12 weeks after the last actual dose of active study drug
Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
Time frame: Within 12 weeks post-treatment
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.
- Results publication: PubMed 24720703Feld JJ, Kowdley KV, Coakley E, Sigal S, Nelson DR, Crawford D, Weiland O, Aguilar H, Xiong J, Pilot-Matias T, DaSilva-Tillmann B, Larsen L, Podsadecki T, Bernstein B. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med. 2014 Apr 24;370(17):1594-603. doi: 10.1056/NEJMoa1315722. Epub 2014 Apr 10.
- Derived from this study: PubMed 29377566Feld JJ, Bernstein DE, Younes Z, Vlierberghe HV, Larsen L, Tatsch F, Ferenci P. Ribavirin dose management in HCV patients receiving ombitasvir/paritaprevir/ritonavir and dasabuvir with ribavirin. Liver Int. 2018 Sep;38(9):1571-1575. doi: 10.1111/liv.13708. Epub 2018 Mar 14.
- Derived from this study: PubMed 27762283Cloherty G, Chevaliez S, Sarrazin C, Herman C, Holzmayer V, Dawson G, Maasoumy B, Vermehren J, Wedemeyer H, Feld JJ, Pawlotsky JM. Hepatitis C RNA assay differences in results: Potential implications for shortened therapy and determination of Sustained Virologic Response. Sci Rep. 2016 Oct 20;6:35410. doi: 10.1038/srep35410.
- Derived from this study: PubMed 27115431Chevaliez S, Feld J, Cheng K, Wedemeyer H, Sarrazin C, Maasoumy B, Herman C, Hackett J, Cohen D, Dawson G, Pawlotsky JM, Cloherty G. Clinical utility of HCV core antigen detection and quantification in the diagnosis and management of patients with chronic hepatitis C receiving an all-oral, interferon-free regimen. Antivir Ther. 2018;23(3):211-217. doi: 10.3851/IMP3042.
- 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.
Nancy Shulman, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ABT-450/r/ABT-267, ABT-333 and Ribavirin in people with Chronic Hepatitis C Infection, run by AbbVie (prior sponsor, Abbott).
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 5 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 6 Jan 2015). 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 After Treatment (time frame: 12 weeks after the last actual dose of active study drug). 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 NCT01716585, which also lists 4 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 12 Jul 2021.