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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))

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ClinicalTrials.gov Identifier: NCT02167945
Recruitment Status : Active, not recruiting
First Posted : June 19, 2014
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 613 participants
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
Estimated Primary Completion Date : May 5, 2020
Estimated Study Completion Date : May 5, 2020

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
tablet

Drug: ABT-333
tablet

Drug: Ribavirin (RBV)
tablet




Primary Outcome Measures :
  1. Incidence of pre-defined clinical outcomes observed during the study [ Time Frame: Up to Post-Treatment week 260 after the subject has taken his/her first 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



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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
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. 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 ClinicalTrials.gov identifier (NCT number): NCT02167945


  Show 48 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02167945     History of Changes
Other Study ID Numbers: M14-222
First Posted: June 19, 2014    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
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)
Analytic Code
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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

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
Cirrhosis
Naïve
Hepatitis C
Hepatitis C Virus
Treatment-Experienced
Relapser
Null responder
Non responder

Additional relevant MeSH terms:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Ritonavir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors