Clinical trial NCT02167945: A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Official title: An Open-Label, Multicenter Study to Evaluate Long-term Outcomes With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Keywords: Hepatitis C Genotype 1
Compensated Cirrhosis
Cirrhosis
Naïve
Hepatitis C
Hepatitis C Virus
Treatment-Experienced
Relapser
Null responder
Non responder
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-06-19
Enrollment: 615
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

Detailed description: This study (TOPAZ-II; M14-222), was a Phase 3b, open-label, multicenter study conducted in the United States which, together with its companion study TOPAZ-I (M14-423; NCT02219490) conducted outside of the United States, was designed with the primary objective of assessing the effect of treatment response on long-term clinical outcomes in adults with chronic HCV GT1 infection with or without compensated cirrhosis, who were either treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies, participants were treated with the 3-DAA regimen with or without RBV. This study consisted of a screening period of up to 42 days, a treatment period of either 12 weeks for HCV GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated cirrhosis, and a 260-week post-treatment period.

Eligibility criteria: Inclusion Criteria:

1. Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
2. Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at screening)
3. HCV genotype 1 infection per screening laboratory result

Exclusion Criteria:

1. Use of contraindicated medications within 2 weeks of dosing
2. Abnormal laboratory tests
3. Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody
4. History of solid organ transplant, clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation
5. Presence of hepatocellular carcinoma at screening

Primary outcomes:
measure: All-Cause Death: Time to Event
timeFrame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
measure: Liver-Related Death: Time to Event
timeFrame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
measure: Liver Decompensation: Time to Event
timeFrame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
measure: Liver Transplantation: Time to Event
timeFrame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
measure: Hepatocellular Carcinoma: Time to Event
timeFrame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
measure: All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
timeFrame: At Post-Treatment Weeks 52, 104, 156, 208, and 260
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
timeFrame: 12 weeks after the last actual dose of study drug
measure: Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
timeFrame: From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24
measure: Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
timeFrame: From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24
measure: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Post-Treatment Week 12 and Post-Treatment Week 24
timeFrame: From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24
measure: Treatment Compliance: Percentage of Tablets Taken Relative to the Total Tablets
timeFrame: Up to Treatment Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Josephs Hospital and Med Center /ID# 127800
state: Arizona
city: Bakersfield
country: United States
facility: Franco Felizarta, Md /Id# 126569
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group /ID# 126577
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center /ID# 128681
state: California
city: Aurora
country: United States
facility: Univ of Colorado Cancer Center /ID# 126568
state: Colorado
city: Washington
country: United States
facility: Medstar Health Research Institute /ID# 128683
state: District of Columbia
city: Bradenton
country: United States
facility: Bach and Godofsky Infec Dis /ID# 128685
state: Florida
city: Gainesville
country: United States
facility: University of Florida - Archer /ID# 127787
state: Florida
city: Jacksonville
country: United States
facility: Encore Borland-Groover Clinical Research /Id# 127781
state: Florida
city: Miami
country: United States
facility: University of Miami /ID# 127622
state: Florida
city: Wellington
country: United States
facility: South Florida Ctr Gastro, P.A. /ID# 126567
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastro Assoc /ID# 126571
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 128684
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center /ID# 126576
state: Illinois
city: Indianapolis
country: United States
facility: Duplicate_Indiana University Health /ID# 126573
state: Indiana
city: New Orleans
country: United States
facility: Tulane University /ID# 127779
state: Louisiana
city: Shreveport
country: United States
facility: Louisana Research Center, LLC /ID# 126561
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University /ID# 127791
state: Maryland
city: Catonsville
country: United States
facility: Digestive Disease Associates - Catonsville /ID# 127624
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 126560
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System /ID# 127783
state: Michigan
city: Plymouth
country: United States
facility: Minnesota Gastroenterology PA /ID# 126579
state: Minnesota
city: Saint Louis
country: United States
facility: St. Louis University /ID# 126564
state: Missouri
city: Egg Harbor Township
country: United States
facility: AGA Clinical Research Associates, LLC /ID# 126578
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey School of Medicine /ID# 128686
state: New Jersey
city: Albuquerque
country: United States
facility: University of New Mexico /ID# 128859
state: New Mexico
city: Santa Fe
country: United States
facility: Southwest Care Center /ID# 127784
state: New Mexico
city: New Hyde Park
country: United States
facility: North Shore University Hospital /ID# 126565
state: New York
city: New York
country: United States
facility: The Mount Sinai Hospital /ID# 128682
state: New York
city: New York
country: United States
facility: Columbia Univ Medical Center /ID# 126566
state: New York
city: New York
country: United States
facility: Columbia Univ Medical Center /ID# 127621
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group - GI Division /ID# 127793
state: New York
city: Rochester
country: United States
facility: Univ Rochester Med Ctr /ID# 127655
state: New York
city: Charlotte
country: United States
facility: Atrium Health Carolinas Medical Center /ID# 127632
state: North Carolina
city: Statesville
country: United States
facility: Carolinas Center For Liver Dis /ID# 127788
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Physicians Company, LLC /ID# 127790
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research, LLC /ID# 127630
state: Oklahoma
city: Providence
country: United States
facility: University Gastroenterology /ID# 127789
state: Rhode Island
city: Germantown
country: United States
facility: Gastro One /ID# 127792
state: Tennessee
city: Baytown
country: United States
facility: Inquest Clinical Research /ID# 126574
state: Texas
city: Houston
country: United States
facility: Cure C Consortium /ID# 126570
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas, P.A /ID# 126563
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research /ID# 126562
state: Texas
city: San Antonio
country: United States
facility: TX Liver Inst, Americ Res Corp /ID# 127623
state: Texas
city: Murray
country: United States
facility: Clinical Research Ctrs America /ID# 127780
state: Utah
city: Seattle
country: United States
facility: Virginia Mason - Seattle Orthapedics /ID# 130288
state: Washington
city: Seattle
country: United States
facility: University of Washington /ID# 127785
state: Washington
city: Madison
country: United States
facility: Dean Clinic /ID# 126575
state: Wisconsin
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: