MedDataX Logo

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

NCT ID: NCT02167945

Last Updated: 2022-07-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

615 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-12

Study Completion Date

2021-05-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02219490

Chronic Hepatitis C Virus (HCV) Infection Genotype 1
COMPLETED PHASE3

A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C

NCT01674725

Chronic Hepatitis C Infection
COMPLETED PHASE3

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

NCT01306617

Chronic Hepatitis C Infection Hepatitis C Hepatitis C Virus
COMPLETED PHASE2

ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis

NCT02517528

Chronic Hepatitis C Virus (HCV)
COMPLETED PHASE3

A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)

NCT01458535

Hepatitis C Virus
COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hepatitis C Virus (HCV) Infection Genotype 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)

Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.

Group Type EXPERIMENTAL

ABT-450/r/ABT-267

Intervention Type DRUG

Tablet for oral use

ABT-333

Intervention Type DRUG

Tablet for oral use

Ribavirin (RBV)

Intervention Type DRUG

Ribavirin was provided as 200 mg tablets, and dosed based on weight, 1000 to 1200 mg divided twice daily per local label. For example, for participants weighing \< 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABT-450/r/ABT-267

Tablet for oral use

Intervention Type DRUG

ABT-333

Tablet for oral use

Intervention Type DRUG

Ribavirin (RBV)

Ribavirin was provided as 200 mg tablets, and dosed based on weight, 1000 to 1200 mg divided twice daily per local label. For example, for participants weighing \< 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABT-450 also known as paritaprevir ABT-267 also known as ombitasvir Paritaprevir/ritonavir/ombitasvir also known as Viekirax ABT-333 also known as dasabuvir ABT-333 also known as Exviera

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Josephs Hospital and Med Center /ID# 127800

Phoenix, Arizona, United States

Site Status

Franco Felizarta, Md /Id# 126569

Bakersfield, California, United States

Site Status

Ruane Clinical Research Group /ID# 126577

Los Angeles, California, United States

Site Status

California Pacific Medical Center /ID# 128681

San Francisco, California, United States

Site Status

Univ of Colorado Cancer Center /ID# 126568

Aurora, Colorado, United States

Site Status

Medstar Health Research Institute /ID# 128683

Washington D.C., District of Columbia, United States

Site Status

Bach and Godofsky Infec Dis /ID# 128685

Bradenton, Florida, United States

Site Status

University of Florida - Archer /ID# 127787

Gainesville, Florida, United States

Site Status

Encore Borland-Groover Clinical Research /Id# 127781

Jacksonville, Florida, United States

Site Status

University of Miami /ID# 127622

Miami, Florida, United States

Site Status

South Florida Ctr Gastro, P.A. /ID# 126567

Wellington, Florida, United States

Site Status

Atlanta Gastro Assoc /ID# 126571

Atlanta, Georgia, United States

Site Status

Northwestern University Feinberg School of Medicine /ID# 128684

Chicago, Illinois, United States

Site Status

The University of Chicago Medical Center /ID# 126576

Chicago, Illinois, United States

Site Status

Duplicate_Indiana University Health /ID# 126573

Indianapolis, Indiana, United States

Site Status

Tulane University /ID# 127779

New Orleans, Louisiana, United States

Site Status

Louisana Research Center, LLC /ID# 126561

Shreveport, Louisiana, United States

Site Status

Johns Hopkins University /ID# 127791

Baltimore, Maryland, United States

Site Status

Digestive Disease Associates - Catonsville /ID# 127624

Catonsville, Maryland, United States

Site Status

Beth Israel Deaconess Medical Center /ID# 126560

Boston, Massachusetts, United States

Site Status

Henry Ford Health System /ID# 127783

Detroit, Michigan, United States

Site Status

Minnesota Gastroenterology PA /ID# 126579

Plymouth, Minnesota, United States

Site Status

St. Louis University /ID# 126564

St Louis, Missouri, United States

Site Status

AGA Clinical Research Associates, LLC /ID# 126578

Egg Harbor, New Jersey, United States

Site Status

Rutgers New Jersey School of Medicine /ID# 128686

Newark, New Jersey, United States

Site Status

University of New Mexico /ID# 128859

Albuquerque, New Mexico, United States

Site Status

Southwest Care Center /ID# 127784

Santa Fe, New Mexico, United States

Site Status

North Shore University Hospital /ID# 126565

New Hyde Park, New York, United States

Site Status

The Mount Sinai Hospital /ID# 128682

New York, New York, United States

Site Status

Columbia Univ Medical Center /ID# 126566

New York, New York, United States

Site Status

Columbia Univ Medical Center /ID# 127621

New York, New York, United States

Site Status

Premier Medical Group - GI Division /ID# 127793

Poughkeepsie, New York, United States

Site Status

Univ Rochester Med Ctr /ID# 127655

Rochester, New York, United States

Site Status

Atrium Health Carolinas Medical Center /ID# 127632

Charlotte, North Carolina, United States

Site Status

Carolinas Center For Liver Dis /ID# 127788

Statesville, North Carolina, United States

Site Status

University of Cincinnati Physicians Company, LLC /ID# 127790

Cincinnati, Ohio, United States

Site Status

Options Health Research, LLC /ID# 127630

Tulsa, Oklahoma, United States

Site Status

University Gastroenterology /ID# 127789

Providence, Rhode Island, United States

Site Status

Gastro One /ID# 127792

Germantown, Tennessee, United States

Site Status

Inquest Clinical Research /ID# 126574

Baytown, Texas, United States

Site Status

Cure C Consortium /ID# 126570

Houston, Texas, United States

Site Status

Liver Associates of Texas, P.A /ID# 126563

Houston, Texas, United States

Site Status

Austin Institute for Clinical Research /ID# 126562

Pflugerville, Texas, United States

Site Status

TX Liver Inst, Americ Res Corp /ID# 127623

San Antonio, Texas, United States

Site Status

Clinical Research Ctrs America /ID# 127780

Murray, Utah, United States

Site Status

Virginia Mason - Seattle Orthapedics /ID# 130288

Seattle, Washington, United States

Site Status

University of Washington /ID# 127785

Seattle, Washington, United States

Site Status

Dean Clinic /ID# 126575

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M14-222

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A Randomized Study to Evaluate the Safety, Tolerability and Antiviral Activity of ABT-450, ABT-333 and ABT-072
NCT01074008 COMPLETED PHASE2
A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis
NCT01704755 COMPLETED PHASE3
A Study to Evaluate the Safety and Antiviral Effect of ABT-450/Ritonavir and ABT-530 Coadministered With and Without Ribavirin in Adults With Genotype 3 Hepatitis C (HCV) Infection
NCT02068222 COMPLETED PHASE2
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1b Infection
NCT01767116 COMPLETED PHASE3
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection
NCT02023112 COMPLETED PHASE3
ABT-450 With Ritonavir and ABT-267 and/or ABT-333 With and Without Ribavirin in Genotype 1 Hepatitis C Virus Infected Patients
NCT01464827 COMPLETED PHASE2
A Study to Evaluate Chronic Hepatitis C Virus (HCV) Infection in Cirrhotic Adults With Genotype 1b (GT1b) Infection
NCT02216422 COMPLETED PHASE3
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)
NCT01221298 COMPLETED PHASE2
An Open-label, Single Arm, Phase 2 Study to Evaluate ABT-450/r/ABT-267 and ABT-333 With Ribavirin (RBV) in Adults With Genotype 1 HCV Infection Taking Methadone or Buprenorphine
NCT01911845 COMPLETED PHASE2
A Study to Evaluate Chronic Hepatitis C Infection in Adults With Genotype 1a Infection
NCT01833533 COMPLETED PHASE3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of ABT-493 and ABT-530 With and Without Ribavirin in Adults With HCV Who Failed a Prior DAA Containing Therapy
NCT02446717 COMPLETED PHASE2/PHASE3
A Multipart, Open-label Study to Evaluate the Safety and Efficacy of ABT-450/r/ABT-267 With and Without ABT-333 Coadministered With and Without Ribavirin in Adult With Genotype 1 or 4 Hepatitis C Virus (HCV) Infection and Human Immunodeficiency Virus, Type 1 Coinfection
NCT01939197 COMPLETED PHASE2/PHASE3
A Study to Evaluate the Safety and Antiviral Effect of Multiple Doses of ABT-493 and ABT-530 in Adults With Genotype 1 Hepatitis C Virus (HCV)
NCT01995071 COMPLETED PHASE2
ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
NCT02517515 COMPLETED PHASE3
A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults
NCT01715415 COMPLETED PHASE3
A Study to Evaluate the Safety and Effect of Co-administration of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Adults With Chronic Hepatitis C Virus Infection
NCT01685203 COMPLETED PHASE2
Ombitasvir/ABT-450/Ritonavir and Dasabuvir Therapy With Low Dose Ribavirin (RBV), Full Dose RBV or RBV Add-On in Treatment Naive Genotype 1a Hepatitis C Virus Infected Adults
NCT02493855 COMPLETED PHASE2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection
NCT02243293 COMPLETED PHASE2/PHASE3
A Study to Evaluate the Safety and Effect of Treatment With Experimental Antiviral Drugs in Combination With Peginterferon Alpha-2a and Ribavirin in People With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie/Abbott Combination Study
NCT01609933 COMPLETED PHASE2
A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection
NCT01672983 COMPLETED PHASE2
A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study
NCT01773070 COMPLETED PHASE3
Ombitasvir/ABT-450 (Paritaprevir)/Ritonavir With Dasabuvir and Ribavirin (RBV) in Treatment Naive and Treatment Experienced Genotype 1a Hepatitis C Virus Infected Adults
NCT02476617 COMPLETED PHASE3
A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
NCT02738138 COMPLETED PHASE3
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults
NCT01854528 COMPLETED PHASE3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Multiple Doses of ABT-333 Alone and in Combination With Pegylated Interferon (pegIFN) and Ribavirin (RBV) in Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
NCT00851890 COMPLETED PHASE2