Clinical trial NCT01221298: A Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV)
Official title: An Open-Label Pilot Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-072 and Ribavirin (RBV) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
HCV
Chronic Hepatitis C Infection
Hepatitis C Genotype 1
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2010-10-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-072 and ribavirin (RBV) in treatment-naïve participants with genotype 1 chronic hepatitis C virus (HCV) infection.

Detailed description: This was a Phase 2a multicenter, open-label, single arm, combination treatment study of a regimen of ABT-450/r/ABT-072, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-(1a or 1b) infected treatment-naïve participants.

Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis C, genotype 1 infection with interleukin 28B (IL28B) rs12979860 genotype C/C.
* Liver biopsy within 3 years with histology consistent with hepatitis C virus (HCV) - induced liver damage, with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.
* Treatment naïve male or female between the ages of 18 and 65.
* Females must be postmenopausal for at least 2 years or surgically sterile.
* Be in a condition of general good health, as perceived by the investigator, other than hepatitis C virus infection.
* Body mass index 18 to \< 35 kg/m\^2 .

Exclusion Criteria:

* Significant sensitivity to any drug.
* Use of herbal supplements within 2 weeks prior to study drug dosing.
* Positive screen for certain drugs or alcohol.
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus (HIV) antibody.
* Use of strong cytochrome P450 3A (CYP3A), cytochrome P450 2C8 (CYP2C8), and organic anion transporting polypeptide 1B1 (OATP1B1) enzyme inducers or inhibitors within 1 month of dosing.
* Prior treatment with any investigational or commercially available anti-hepatitis C virus agents.
* Abnormal laboratory tests.
* Cirrhosis or extensive bridging fibrosis.
* History of cardiac disease.

Primary outcomes:
measure: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Quantitation (LLOQ) From Week 4 Through Week 12
timeFrame: Week 4 through Week 12
Secondary outcomes:
measure: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < 1000 International Units Per Milliliter (IU/mL)
timeFrame: Week 2
measure: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Below the Lower Limit of Quantitation (LLOQ) at Week 4
timeFrame: Week 4
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-treatment
timeFrame: Post-treatment Day 1 to Post-treatment Week 12
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) Post-Treatment
timeFrame: Post-treatment Day 1 to Post-treatment Week 24
measure: Time to Failure to Suppress or Rebound During Treatment
timeFrame: Day 1 through Week 12
measure: Time to Virologic Relapse Through 24 Weeks Post-treatment
timeFrame: Post-treatment Day 1 to Post-treatment Week 24
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 41128
state: California
city: Chicago
country: United States
facility: Site Reference ID/Investigator# 42262
state: Illinois
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 41127
state: Texas
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 43182
state: Washington
Study officials:
affiliation: AbbVie
name: Daniel Cohen, MD
role: STUDY_DIRECTOR
References:
citation: Lawitz E, Poordad F, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, Larsen L, Menon R, Koev G, Tripathi R, Pilot-Matias T, Bernstein B. A phase 2a trial of 12-week interferon-free therapy with two direct-acting antivirals (ABT-450/r, ABT-072) and ribavirin in IL28B C/C patients with chronic hepatitis C genotype 1. J Hepatol. 2013 Jul;59(1):18-23. doi: 10.1016/j.jhep.2013.02.009. Epub 2013 Feb 22.