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Trial record 1 of 2 for:    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
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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 : Active, not recruiting
First Posted : August 19, 2014
Last Update Posted : June 1, 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 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 1596 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-I)
Actual Study Start Date : October 30, 2014
Estimated Primary Completion Date : May 13, 2021
Estimated 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-333
tablet

Drug: ABT-450/r/ABT-267
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 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



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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

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


  Show 187 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: AbbVie Inc. AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02219490     History of Changes
Other Study ID Numbers: M14-423
2014-001022-14 ( EudraCT Number )
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Infection
Communicable Diseases
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Ritonavir
Liver Diseases
Digestive System Diseases
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