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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 ((TOPAZ II))

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02167945
Recruitment Status : Completed
First Posted : June 19, 2014
Last Update Posted : June 1, 2021
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to evaluate Long-term Outcomes following treatment with ABT-450/r/ABT-267, ABT-333 with or without RBV in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Virus (HCV) Infection Genotype 1 Drug: ABT-450/r/ABT-267 Drug: ABT-333 Drug: Ribavirin (RBV) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 615 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 12, 2014
Actual Primary Completion Date : May 13, 2021
Actual Study Completion Date : May 13, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)
ABT-450/r/ABT-267 and ABT-333 coadministered with or without ribavirin (RBV) for 12 or 24 weeks
Drug: ABT-450/r/ABT-267

Drug: ABT-333

Drug: Ribavirin (RBV)

Primary Outcome Measures :
  1. Incidence of pre-defined clinical outcomes observed during the studies M14-222 and M14-423 [ Time Frame: Up to Post-Treatment week 260 after the last participant of the study M14-222 or M14-423 has taken his/her last dose of study drug ]
    Measured by all-cause death, liver-related death, liver decompensation, liver transplantation, and hepatocellular carcinoma.

Secondary Outcome Measures :
  1. Change in Quality of Life [ Time Frame: From Day 1 to Post-Treatment Week 12 and Post-Treatment Week 24. ]
    Assessed by Short-Form 36 Version 2 health survey (SF-36v2).

  2. Change in fatigue [ Time Frame: From Day 1 to Post-Treatment Week 12 and Post-Treatment Week 24. ]
    Measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaires

  3. Percentage of subjects with sustained virologic response 12 weeks post-treatment (SVR12) [ Time Frame: 12 weeks after the last actual dose of study drug ]
    Hepatitis C virus ribonucleic acid less than the lower limit of quantification

  4. Evaluation of adherence to study drug regimens [ Time Frame: Up to Treatment Week 24 ]
    Measured by pill counts for each type of tablet

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02167945

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Sponsors and Collaborators
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Study Director: ABBVIE INC. AbbVie
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Responsible Party: AbbVie Identifier: NCT02167945    
Other Study ID Numbers: M14-222
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: June 1, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Hepatitis C Genotype 1
Compensated Cirrhosis
Hepatitis C
Hepatitis C Virus
Null responder
Non responder
Additional relevant MeSH terms:
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Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents