Clinical trial NCT01306617: A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-333 and Ribavirin (RBV) in Treatment-Naïve and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Official title: An Open-Label Pilot Study to Evaluate the Antiviral Activity, Safety and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) Dosed in Combination With ABT-333 and Ribavirin (RBV) in Treatment-Naive and Non-responder Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C Infection
Hepatitis C
Hepatitis C Virus
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-03-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection.

Detailed description: This was a phase 2a multicenter, open-label, sequential, 3-arm, combination treatment study of a regimen of ABT-450/r/ABT-333, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected treatment-naïve participants and previous non-responders to pegylated interferon (pegIFN)/RBV treatment.

Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis C virus (HCV)
* Treatment naive, null or partial responders to previous treatment with peginterferon and ribavirin
* Males and females 18-65 years old
* Body mass index 18 to \< 35 kg/m\^2
* Females must be postmenopausal for at least 2 years or surgically sterile

Exclusion Criteria:

* Cirrhosis or extensive bridging fibrosis
* History of cardiac disease
* Positive screen for certain drugs or alcohol
* Abnormal laboratory results
* Significant sensitivity to any drug
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus 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

Primary outcomes:
measure: Percentage of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Suppressed Below the Lower Limit of Detection (LLOD) From Week 4 Through Week 12
timeFrame: Week 4 through Week 12
Secondary outcomes:
measure: Percentage of Participants With HCV RNA < 1000 International Units Per Milliliter (IU/mL)
timeFrame: Week 2
measure: Percentage of Participants With HCV RNA Below the Lower Limit of Quantitation (LLOQ; <25 IU/mL) 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 Post-treatment
timeFrame: Post-treatment Day 1 to post-treatment week 48
measure: Resistance-Associated Variants and Phenotypic Resistance
timeFrame: Day 1 to post-treatment week 48
measure: Pharmacokinetics (C Trough) of ABT 450 in HCV Infected Participants
timeFrame: Day 1 to Week 12
measure: Pharmacokinetics (C Trough) of ABT-333 in HCV Infected Participants
timeFrame: Day 1 to Week 12
measure: Pharmacokinetics (C Trough) of Ritonavir in HCV Infected Participants
timeFrame: Day 1 to Week 12
measure: Pharmacokinetics (C Trough) of Ribavirin in HCV Infected Participants
timeFrame: Day 1 to Week 12
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Site Reference ID/Investigator# 48263
state: California
city: Aurora
country: United States
facility: Site Reference ID/Investigator# 48264
state: Colorado
city: Gainesville
country: United States
facility: Site Reference ID/Investigator# 51282
state: Florida
city: Springfield
country: United States
facility: Site Reference ID/Investigator# 50425
state: Massachusetts
city: Kansas City
country: United States
facility: Site Reference ID/Investigator# 50423
state: Missouri
city: New York
country: United States
facility: Site Reference ID/Investigator# 48268
state: New York
city: Statesville
country: United States
facility: Site Reference ID/Investigator# 50428
state: North Carolina
city: San Antonio
country: United States
facility: Site Reference ID/Investigator# 48266
state: Texas
city: Newport News
country: United States
facility: Site Reference ID/Investigator# 50427
state: Virginia
city: Seattle
country: United States
facility: Site Reference ID/Investigator# 48265
state: Washington
city: Madison
country: United States
facility: Site Reference ID/Investigator# 50424
state: Wisconsin
Study officials:
affiliation: AbbVie
name: Daniel Cohen, MD
role: STUDY_DIRECTOR
References:
citation: Poordad F, Lawitz E, Kowdley KV, Cohen DE, Podsadecki T, Siggelkow S, Heckaman M, Larsen L, Menon R, Koev G, Tripathi R, Pilot-Matias T, Bernstein B. Exploratory study of oral combination antiviral therapy for hepatitis C. N Engl J Med. 2013 Jan 3;368(1):45-53. doi: 10.1056/NEJMoa1208809.