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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-I)

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ClinicalTrials.gov Identifier: NCT02219490
Recruitment Status : Completed
First Posted : August 19, 2014
Last Update Posted : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
The purpose of this study is to evaluate Long-term outcomes following treatment with ABT-450/r/ABT-267 and 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-333 Drug: ABT-450/r/ABT-267 Drug: Ribavirin (RBV) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1596 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-I)
Actual Study Start Date : October 30, 2014
Actual Primary Completion Date : May 13, 2021
Actual Study Completion Date : May 13, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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-333
tablet

Drug: ABT-450/r/ABT-267
tablet

Drug: Ribavirin (RBV)
tablet


Outcome Measures
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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. 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 ribonucleic acid less than the lower limit of quantification

  2. Change in fibrosis [ Time Frame: Up to Post-Treatment week 260 after the subject has taken his/her last dose of study drug ]
    Measured by change from Day 1 in liver stiffness measured by FibroScan, where available


Eligibility Criteria
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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. Males and females at least 18 years old at screening
  2. Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
  3. Chronic hepatitis C, genotype 1 infection
  4. Males must be surgically sterile or agree to practice acceptable forms of birth control
  5. Screening laboratory result indicating HCV genotype 1 infection

Exclusion Criteria:

  1. Use of contraindicated medications within 2 weeks of dosing
  2. Abnormal laboratory tests
  3. Current or past clinical evidence of Child-Pugh B or C classification or history of liver decompensation
  4. Confirmed presence of hepatocellular carcinoma
  5. History of solid organ transplant
Contacts and Locations
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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): NCT02219490


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02219490    
Other Study ID Numbers: M14-423
2014-001022-14 ( EudraCT Number )
First Posted: August 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)
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

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Studies a U.S. FDA-regulated Drug Product: No
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
Naive
 Treatment-Experienced
Relapser
Null responder
Non responder
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Disease Attributes
Pathologic Processes
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents