- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01716585
A Study to Evaluate Chronic Hepatitis C Infection
July 8, 2021 updated by: AbbVie (prior sponsor, Abbott)
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
636
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ABT-450/r/ABT-267 and ABT-333, plus RBV
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
|
Capsule (double-blind treatment period), tablet (open-label treatment period)
ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
|
Experimental: Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV
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
|
Capsule (double-blind treatment period), tablet (open-label treatment period)
Tablet
Tablet
Capsule
ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks after the last actual dose of active study drug
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period
Time Frame: At 12 weeks
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Within 12 weeks post-treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nancy Shulman, MD, AbbVie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Feld 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.
- 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.
- Cloherty 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.
- Chevaliez 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2012
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2014
Study Registration Dates
First Submitted
October 18, 2012
First Submitted That Met QC Criteria
October 26, 2012
First Posted (Estimate)
October 30, 2012
Study Record Updates
Last Update Posted (Actual)
July 12, 2021
Last Update Submitted That Met QC Criteria
July 8, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Disease Attributes
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Infections
- Communicable Diseases
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Ribavirin
Other Study ID Numbers
- M11-646
- 2012-002019-25 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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