Clinical trial NCT01716585: A Study to Evaluate Chronic Hepatitis C Infection
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
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
paritaprevir
dasabuvir
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-10-30
Enrollment: 636
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
timeFrame: 12 weeks after the last actual dose of active study drug
Secondary outcomes:
measure: Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) at Final Treatment Visit During the Double-Blind Treatment Period
timeFrame: At 12 weeks
measure: Percentage of HCV Genotype 1a-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
timeFrame: 12 weeks after the last actual dose of active study drug
measure: Percentage of HCV Genotype 1b-infected Participants With Sustained Virologic Response 12 Weeks After Treatment
timeFrame: 12 weeks after the last actual dose of active study drug
measure: 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
timeFrame: 12 weeks after the last actual dose of active study drug
measure: Percentage of Participants With Virologic Relapse After Treatment: ABT-450/r/ABT-267 and ABT-333, Plus RBV Arm
timeFrame: Within 12 weeks post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Nancy Shulman, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.