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Trial record 3 of 30 for:    TOPAZ study

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.
 
ClinicalTrials.gov Identifier: NCT02167945
Recruitment Status : Active, not recruiting
First Posted : June 19, 2014
Last Update Posted : November 27, 2020
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE June 18, 2014
First Posted Date  ICMJE June 19, 2014
Last Update Posted Date November 27, 2020
Actual Study Start Date  ICMJE June 12, 2014
Estimated Primary Completion Date May 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2020)
  • 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).
  • 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
  • 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
  • Evaluation of adherence to study drug regimens [ Time Frame: Up to Treatment Week 24 ]
    Measured by pill counts for each type of tablet
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
  • 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
  • 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
  • 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).
  • Evaluation of adherence to study drug regimens [ Time Frame: Up to Treatment Week 24 ]
    Measured by pill counts for each type of tablet
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Intervention  ICMJE
  • Drug: ABT-450/r/ABT-267
    tablet
  • Drug: ABT-333
    tablet
  • Drug: Ribavirin (RBV)
    tablet
Study Arms  ICMJE 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
Interventions:
  • Drug: ABT-450/r/ABT-267
  • Drug: ABT-333
  • Drug: Ribavirin (RBV)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 13, 2019)
615
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2014)
600
Estimated Study Completion Date  ICMJE May 12, 2021
Estimated Primary Completion Date May 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02167945
Other Study ID Numbers  ICMJE M14-222
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP