Back to resultsA 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)
Primary Purpose
Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ABT-450/r/ABT-267
ABT-333
Ribavirin (RBV)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C Virus (HCV) Infection Genotype 1 focused on measuring Hepatitis C Genotype 1, Compensated Cirrhosis, Cirrhosis, Naïve, Hepatitis C, Hepatitis C Virus, Treatment-Experienced, Relapser, Null responder, Non responder
Eligibility Criteria
Inclusion Criteria:
- Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
- Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at screening)
- HCV genotype 1 infection per screening laboratory result
Exclusion Criteria:
- Use of contraindicated medications within 2 weeks of dosing
- Abnormal laboratory tests
- Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody
- History of solid organ transplant, clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation
- Presence of hepatocellular carcinoma at screening
Sites / Locations
- St. Josephs Hospital and Med Center /ID# 127800
- Franco Felizarta, Md /Id# 126569
- Ruane Clinical Research Group /ID# 126577
- California Pacific Medical Center /ID# 128681
- Univ of Colorado Cancer Center /ID# 126568
- Medstar Health Research Institute /ID# 128683
- Bach and Godofsky Infec Dis /ID# 128685
- University of Florida - Archer /ID# 127787
- Encore Borland-Groover Clinical Research /Id# 127781
- University of Miami /ID# 127622
- South Florida Ctr Gastro, P.A. /ID# 126567
- Atlanta Gastro Assoc /ID# 126571
- Northwestern University Feinberg School of Medicine /ID# 128684
- The University of Chicago Medical Center /ID# 126576
- Duplicate_Indiana University Health /ID# 126573
- Tulane University /ID# 127779
- Louisana Research Center, LLC /ID# 126561
- Johns Hopkins University /ID# 127791
- Digestive Disease Associates - Catonsville /ID# 127624
- Beth Israel Deaconess Medical Center /ID# 126560
- Henry Ford Health System /ID# 127783
- Minnesota Gastroenterology PA /ID# 126579
- St. Louis University /ID# 126564
- AGA Clinical Research Associates, LLC /ID# 126578
- Rutgers New Jersey School of Medicine /ID# 128686
- University of New Mexico /ID# 128859
- Southwest Care Center /ID# 127784
- North Shore University Hospital /ID# 126565
- The Mount Sinai Hospital /ID# 128682
- Columbia Univ Medical Center /ID# 126566
- Columbia Univ Medical Center /ID# 127621
- Premier Medical Group - GI Division /ID# 127793
- Univ Rochester Med Ctr /ID# 127655
- Atrium Health Carolinas Medical Center /ID# 127632
- Carolinas Center For Liver Dis /ID# 127788
- University of Cincinnati Physicians Company, LLC /ID# 127790
- Options Health Research, LLC /ID# 127630
- University Gastroenterology /ID# 127789
- Gastro One /ID# 127792
- Inquest Clinical Research /ID# 126574
- Cure C Consortium /ID# 126570
- Liver Associates of Texas, P.A /ID# 126563
- Austin Institute for Clinical Research /ID# 126562
- TX Liver Inst, Americ Res Corp /ID# 127623
- Clinical Research Ctrs America /ID# 127780
- Virginia Mason - Seattle Orthapedics /ID# 130288
- University of Washington /ID# 127785
- Dean Clinic /ID# 126575
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)
Arm Description
Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
Outcomes
Primary Outcome Measures
All-Cause Death: Time to Event
Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Liver-Related Death: Time to Event
Time to liver-related death was defined as number of days from the 1st day of study drug dosing for the participant to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Liver Decompensation: Time to Event
Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Liver Transplantation: Time to Event
Time to liver transplantation was defined as number of days from the 1st day of study drug dosing for the participant to date of liver transplantation. All liver transplantation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Hepatocellular Carcinoma: Time to Event
Time to hepatocellular carcinoma was defined as number of days from the 1st day of study drug dosing for the participant to date of hepatocellular carcinoma. All hepatocellular carcinoma was to be included, whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for hepatocellular carcinoma. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-I; NCT02219490.
Secondary Outcome Measures
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of 4 weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores for each domain and PCS/MCS range from 0-100: higher scores indicate a better state of health. Positive numbers indicate improvement from baseline.
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of 4 weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores for each domain and PCS/MCS range from 0-100: higher scores indicate a better state of health. Positive numbers indicate improvement from baseline.
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Post-Treatment Week 12 and Post-Treatment Week 24
The FACIT-F is a symptom specific instrument with a focus on measuring fatigue in a variety of chronic diseases or health conditions. It was originally developed from interviews with oncology patients and clinical experts to assess anemia-associated fatigue. Its 13-item-version assesses peripheral, central, or mixed fatigue with a recall period of 7 days and yields a summed total score ranging between 0 and 52. Higher FACIT-F scores indicate a lesser degree of fatigue. Positive numbers indicate improvement from baseline.
Treatment Compliance: Percentage of Tablets Taken Relative to the Total Tablets
Treatment compliance was calculated as the percentage of tablets taken (presumed as [tablets dispensed-tablets returned]) relative to the total tablets, respectively, expected to be taken. Study drug interruptions due to an adverse event or other planned interruptions recorded on the electronic case report form (eCRF) were to be subtracted from the duration. For compliance to ribavirin (RBV), RBV dose modifications due to adverse events, toxicity management, or weight changes as recorded on the RBV Dose Modifications eCRF were to be used to modify the total number of tablets that should have been taken. A participant is considered to be compliant if the percentage is between 80% and 120%.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02167945
Brief Title
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
Acronym
TOPAZ-II
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 12, 2014 (Actual)
Primary Completion Date
May 13, 2021 (Actual)
Study Completion Date
May 13, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.
Detailed Description
This study (TOPAZ-II; M14-222), was a Phase 3b, open-label, multicenter study conducted in the United States which, together with its companion study TOPAZ-I (M14-423; NCT02219490) conducted outside of the United States, was designed with the primary objective of assessing the effect of treatment response on long-term clinical outcomes in adults with chronic HCV GT1 infection with or without compensated cirrhosis, who were either treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies, participants were treated with the 3-DAA regimen with or without RBV. This study consisted of a screening period of up to 42 days, a treatment period of either 12 weeks for HCV GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated cirrhosis, and a 260-week post-treatment period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Virus (HCV) Infection Genotype 1
Keywords
Hepatitis C Genotype 1, Compensated Cirrhosis, Cirrhosis, Naïve, Hepatitis C, Hepatitis C Virus, Treatment-Experienced, Relapser, Null responder, Non responder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
615 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)
Arm Type
Experimental
Arm Description
Participants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
Intervention Type
Drug
Intervention Name(s)
ABT-450/r/ABT-267
Other Intervention Name(s)
ABT-450 also known as paritaprevir, ABT-267 also known as ombitasvir, Paritaprevir/ritonavir/ombitasvir also known as Viekirax
Intervention Description
Tablet for oral use
Intervention Type
Drug
Intervention Name(s)
ABT-333
Other Intervention Name(s)
ABT-333 also known as dasabuvir, ABT-333 also known as Exviera
Intervention Description
Tablet for oral use
Intervention Type
Drug
Intervention Name(s)
Ribavirin (RBV)
Intervention Description
Ribavirin was provided as 200 mg tablets, and dosed based on weight, 1000 to 1200 mg divided twice daily per local label. For example, for participants weighing < 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.
Primary Outcome Measure Information:
Title
All-Cause Death: Time to Event
Description
Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Time Frame
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Title
Liver-Related Death: Time to Event
Description
Time to liver-related death was defined as number of days from the 1st day of study drug dosing for the participant to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Time Frame
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Title
Liver Decompensation: Time to Event
Description
Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Time Frame
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Title
Liver Transplantation: Time to Event
Description
Time to liver transplantation was defined as number of days from the 1st day of study drug dosing for the participant to date of liver transplantation. All liver transplantation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Time Frame
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Title
Hepatocellular Carcinoma: Time to Event
Description
Time to hepatocellular carcinoma was defined as number of days from the 1st day of study drug dosing for the participant to date of hepatocellular carcinoma. All hepatocellular carcinoma was to be included, whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for hepatocellular carcinoma. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-II (this study) and the companion study TOPAZ-I (M14-423; NCT02219490).
Time Frame
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Title
All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event
Description
Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-I; NCT02219490.
Time Frame
At Post-Treatment Weeks 52, 104, 156, 208, and 260
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
Description
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Time Frame
12 weeks after the last actual dose of study drug
Title
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
Description
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of 4 weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores for each domain and PCS/MCS range from 0-100: higher scores indicate a better state of health. Positive numbers indicate improvement from baseline.
Time Frame
From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24
Title
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at Post-Treatment Week 12 and Post-Treatment Week 24
Description
The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of 4 weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 scores for each domain and PCS/MCS range from 0-100: higher scores indicate a better state of health. Positive numbers indicate improvement from baseline.
Time Frame
From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24
Title
Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Total Score at Post-Treatment Week 12 and Post-Treatment Week 24
Description
The FACIT-F is a symptom specific instrument with a focus on measuring fatigue in a variety of chronic diseases or health conditions. It was originally developed from interviews with oncology patients and clinical experts to assess anemia-associated fatigue. Its 13-item-version assesses peripheral, central, or mixed fatigue with a recall period of 7 days and yields a summed total score ranging between 0 and 52. Higher FACIT-F scores indicate a lesser degree of fatigue. Positive numbers indicate improvement from baseline.
Time Frame
From Baseline to Post-Treatment Week 12 and Post-Treatment Week 24
Title
Treatment Compliance: Percentage of Tablets Taken Relative to the Total Tablets
Description
Treatment compliance was calculated as the percentage of tablets taken (presumed as [tablets dispensed-tablets returned]) relative to the total tablets, respectively, expected to be taken. Study drug interruptions due to an adverse event or other planned interruptions recorded on the electronic case report form (eCRF) were to be subtracted from the duration. For compliance to ribavirin (RBV), RBV dose modifications due to adverse events, toxicity management, or weight changes as recorded on the RBV Dose Modifications eCRF were to be used to modify the total number of tablets that should have been taken. A participant is considered to be compliant if the percentage is between 80% and 120%.
Time Frame
Up to Treatment Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control
Chronic hepatitis C, genotype 1-infection (HCV RNA level greater than 1,000 IU/mL at screening)
HCV genotype 1 infection per screening laboratory result
Exclusion Criteria:
Use of contraindicated medications within 2 weeks of dosing
Abnormal laboratory tests
Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody
History of solid organ transplant, clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation
Presence of hepatocellular carcinoma at screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
St. Josephs Hospital and Med Center /ID# 127800
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Franco Felizarta, Md /Id# 126569
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Ruane Clinical Research Group /ID# 126577
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
California Pacific Medical Center /ID# 128681
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Univ of Colorado Cancer Center /ID# 126568
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Medstar Health Research Institute /ID# 128683
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Bach and Godofsky Infec Dis /ID# 128685
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
University of Florida - Archer /ID# 127787
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Encore Borland-Groover Clinical Research /Id# 127781
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
University of Miami /ID# 127622
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
South Florida Ctr Gastro, P.A. /ID# 126567
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
Atlanta Gastro Assoc /ID# 126571
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine /ID# 128684
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
The University of Chicago Medical Center /ID# 126576
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
Duplicate_Indiana University Health /ID# 126573
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Tulane University /ID# 127779
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112-2699
Country
United States
Facility Name
Louisana Research Center, LLC /ID# 126561
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105-6800
Country
United States
Facility Name
Johns Hopkins University /ID# 127791
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Digestive Disease Associates - Catonsville /ID# 127624
City
Catonsville
State/Province
Maryland
ZIP/Postal Code
21228
Country
United States
Facility Name
Beth Israel Deaconess Medical Center /ID# 126560
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215-5400
Country
United States
Facility Name
Henry Ford Health System /ID# 127783
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Gastroenterology PA /ID# 126579
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
St. Louis University /ID# 126564
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
AGA Clinical Research Associates, LLC /ID# 126578
City
Egg Harbor Township
State/Province
New Jersey
ZIP/Postal Code
08234
Country
United States
Facility Name
Rutgers New Jersey School of Medicine /ID# 128686
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
University of New Mexico /ID# 128859
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102-4517
Country
United States
Facility Name
Southwest Care Center /ID# 127784
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
North Shore University Hospital /ID# 126565
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
The Mount Sinai Hospital /ID# 128682
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 126566
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Columbia Univ Medical Center /ID# 127621
City
New York
State/Province
New York
ZIP/Postal Code
10032-3725
Country
United States
Facility Name
Premier Medical Group - GI Division /ID# 127793
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Univ Rochester Med Ctr /ID# 127655
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Atrium Health Carolinas Medical Center /ID# 127632
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Carolinas Center For Liver Dis /ID# 127788
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
University of Cincinnati Physicians Company, LLC /ID# 127790
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-2827
Country
United States
Facility Name
Options Health Research, LLC /ID# 127630
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
University Gastroenterology /ID# 127789
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Gastro One /ID# 127792
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Inquest Clinical Research /ID# 126574
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521-2415
Country
United States
Facility Name
Cure C Consortium /ID# 126570
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Liver Associates of Texas, P.A /ID# 126563
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2783
Country
United States
Facility Name
Austin Institute for Clinical Research /ID# 126562
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
TX Liver Inst, Americ Res Corp /ID# 127623
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Clinical Research Ctrs America /ID# 127780
City
Murray
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Virginia Mason - Seattle Orthapedics /ID# 130288
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington /ID# 127785
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Dean Clinic /ID# 126575
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53715
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
For details on when studies are available for sharing, please refer to the link below.
IPD Sharing 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 Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Learn more about this trial
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
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