HEMATITE: Quality of Life Measurement in Treatment Naïve Patients With Hepatitis C Virus (HCV) Genotype 1 (GT1) Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir and Dasabuvir (Viekirax®/Exviera®)
Sponsor
AbbVie (Industry)
Overall Status
Completed
CT.gov ID
NCT03002818
Collaborator
(none)
41
5
13.8
8.2
0.6
Study Details
Study Description
Brief Summary
This is an observational, prospective, open-label, single-arm, multicenter, real-life study designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen) on total daytime physical activity and fatigue in participants with HCV GT1.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
41 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Quality of Life Measurement Using Wrist Actigraphy in HCV Genotype 1 Infected, Treatment naïve Patients Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir Tablets and Dasabuvir Tablets (Viekirax®/Exviera®; 3D Regimen): The HEMATITE Study
Actual Study Start Date
:
Mar 1, 2017
Actual Primary Completion Date
:
Apr 25, 2018
Actual Study Completion Date
:
Apr 25, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| HCV Genotype 1 Participants Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
Outcome Measures
Primary Outcome Measures
- Change From Baseline at Day 168 in Mean Daytime Physical Activity [Baseline, Day 168]
Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.
Secondary Outcome Measures
- Change From Baseline Over Time in Mean Daytime Physical Activity [Baseline, Days 28, 84, 168]
Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity.
- Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score [Baseline, Days 28, 84, 168]
The FSS is a 9-item questionnaire assessing the functional impact of fatigue during the past two weeks on multiple life domains using scales from 1 (strongly disagree) to 7 (strongly agree). The fatigue score is the mean score of the 9 items, with lower scores indicating less fatigue severity. Clinically significant fatigue is usually defined as score equal or above 4. Changes were calculated by the formula "Baseline minus Day 28, Day 84, or Day 168." Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement.
- Change From Baseline Over Time in Sleep Efficiency [Baseline, Days 28, 84, 168]
Sleep efficiency for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link). Sleep efficiency was defined as the percent of time scored as sleep during the sleep period, from 0% to 100%. Changes were calculated by the formula "Baseline minus Day 28, Day 84, or Day 168." Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement.
- Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population [Baseline, Days 28, 84, 168]
The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.
- Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population [Baseline, Days 28, 84, 168]
The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.
- Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population [Baseline, Days 28, 84, 168]
The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.
- Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population [Baseline, Days 28, 84, 168]
The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated.
- Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment [Day 168 (or 12 weeks after the last dose of study drug)]
SVR12 defined as hepatitis C virus ribonucleic acid (HCV RNA) not detectable 12 weeks after the last actual dose of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Treatment-naïve participants
-
Mono-infected participants with chronic HCV GT1
-
Non-cirrhotic participants
-
Participants with debilitating fatigue (Fatigue Severity Scale [FSS] greater than or equal to 4)
Exclusion Criteria:
-
Participants with sources of fatigue other than HCV (especially, severe depression, cancer and hormonal disorders causing clinically significant fatigue)
-
Participants with conditions that do not allow to adhere to protocol and use of the device at investigator's discretion
-
Participants who are wheelchair dependent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kantonsspital St. Gallen | St. Gallen | Sankt Gallen | Switzerland | 9007 |
| 2 | Inselspital, Universitaetsklin | Bern | Switzerland | 3010 | |
| 3 | Fondazione Epatocentro Ticino | Lugano | Switzerland | 6900 | |
| 4 | Hopital Neuchatelois | Neuchatel | Switzerland | CH-2000 | |
| 5 | Universitaetsspital Zuerich | Zurich | Switzerland | 8091 |
Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc., AbbVie
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT03002818
Other Study ID Numbers:
- P16-272
First Posted:
Dec 26, 2016
Last Update Posted:
Oct 23, 2019
Last Verified:
May 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
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
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Hepatitis C Virus (HCV) Genotype 1 Participants |
|---|---|
| Arm/Group Description | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
| Period Title: Overall Study | |
| STARTED | 41 |
| COMPLETED | 40 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | HCV Genotype 1 Participants |
|---|---|
| Arm/Group Description | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
| Overall Participants | 41 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
49.4
(12.7)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
27
65.9%
|
| Male |
14
34.1%
|
| Race/Ethnicity, Customized (Count of Participants) | |
| Caucasian |
41
100%
|
| Mean Daytime Physical Activity (day-counts) [Mean (Standard Deviation) ] | |
| sdITT Population |
1469569
(405329)
|
| mITT Population |
1513166
(410686)
|
| Fatigue Severity Scale (FSS) (score on a scale) [Median (Standard Deviation) ] | |
| sdITT Population |
5.95
(0.61)
|
| mITT Population |
5.94
(0.67)
|
| Sleep Efficiency (percent of time asleep) [Mean (Standard Deviation) ] | |
| sdITT Population |
89.4
(4.58)
|
| mITT Population |
89.8
(3.76)
|
Outcome Measures
| Title | Change From Baseline at Day 168 in Mean Daytime Physical Activity |
|---|---|
| Description | Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity. |
| Time Frame | Baseline, Day 168 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point. |
| Arm/Group Title | HCV Genotype 1 Participants |
|---|---|
| Arm/Group Description | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
| Measure Participants | 26 |
| Change at Day 168: sdITT Population |
-108266
(313859)
|
| Change at Day 168: mITT Population |
-98373
(325138)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | sdITT (n=26): Change at Day 168 minus Baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.091 |
| Comments | ||
| Method | one-sample t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | mean change |
| Estimated Value | -108266 | |
| Confidence Interval |
(2-Sided) 95% -235037 to 18504 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | mITT (n=24): Change at Day 168 minus Baseline | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.152 |
| Comments | ||
| Method | one-sample t-test | |
| Comments | ||
| Method of Estimation | Estimation Parameter | mean change |
| Estimated Value | -98373 | |
| Confidence Interval |
(2-Sided) 95% -235667 to 38921 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | sdITT (n=26): Baseline vs. Day 168 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.091 |
| Comments | ||
| Method | paired t-test | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | mITT (n=24): Baseline vs. Day 168 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.152 |
| Comments | ||
| Method | paired t-test | |
| Comments | ||
| Title | Change From Baseline Over Time in Mean Daytime Physical Activity |
|---|---|
| Description | Mean daytime physical activity for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link), which measures activity via a 3-axis algorithm. For total daytime physical activity, the measured counts of the activity tracker data minus total sleep counts were used as day-counts. Higher day-counts signify more activity. |
| Time Frame | Baseline, Days 28, 84, 168 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point. |
| Arm/Group Title | HCV Genotype 1 Participants |
|---|---|
| Arm/Group Description | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
| Measure Participants | 34 |
| Change at Day 28: sdITT Population |
26990
(211108)
|
| Change at Day 28: mITT Population |
21422
(215104)
|
| Change at Day 84: sdITT Population |
-6448
(198441)
|
| Change at Day 84: mITT Population |
-13020
(197825)
|
| Change at Day 168: sdITT Population |
-108266
(313859)
|
| Change at Day 168: mITT Population |
-98373
(325138)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | sdITT (n=34): Baseline vs. Day 28 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.461 |
| Comments | ||
| Method | paired t-test | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | mITT (n=24): Baseline vs. Day 28 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.630 |
| Comments | ||
| Method | paired t-test | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | sdITT (n=32): Baseline vs. Day 84 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.855 |
| Comments | ||
| Method | paired t-test | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | mITT (n=24): Baseline vs. Day 84 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.750 |
| Comments | ||
| Method | paired t-test | |
| Comments | ||
| Title | Change From Baseline Over Time in Fatigue Severity Scale (FSS) Score |
|---|---|
| Description | The FSS is a 9-item questionnaire assessing the functional impact of fatigue during the past two weeks on multiple life domains using scales from 1 (strongly disagree) to 7 (strongly agree). The fatigue score is the mean score of the 9 items, with lower scores indicating less fatigue severity. Clinically significant fatigue is usually defined as score equal or above 4. Changes were calculated by the formula "Baseline minus Day 28, Day 84, or Day 168." Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement. |
| Time Frame | Baseline, Days 28, 84, 168 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point. |
| Arm/Group Title | HCV Genotype 1 Participants |
|---|---|
| Arm/Group Description | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
| Measure Participants | 36 |
| Change at Day 28: sdITT Population |
0.69
(1.01)
|
| Change at Day 28: mITT Population |
0.85
(1.06)
|
| Change at Day 84: sdITT Population |
1.68
(1.54)
|
| Change at Day 84: mITT Population |
1.76
(1.64)
|
| Change at Day 168: sdITT Population |
2.60
(1.62)
|
| Change at Day 168: mITT Population |
2.82
(1.52)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | sdITT: mean change Baseline minus Day 168 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | mean change |
| Estimated Value | 2.60 | |
| Confidence Interval |
(2-Sided) 95% 2.063 to 3.137 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | mITT: mean change Baseline minus Day 168 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | mean change |
| Estimated Value | 2.82 | |
| Confidence Interval |
(2-Sided) 95% 2.212 to 3.428 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | sdITT (n=37): Baseline vs. Day 168 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Paired Wilcoxon Test | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | mITT (n=24): Baseline vs. Day 168 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Paired Wilcoxon Test | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | sdITT (n=35): Baseline vs. Day 28 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Paired Wilcoxon Test | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | mITT (n=22): Baseline vs. Day 28 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Paired Wilcoxon Test | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | sdITT (n=36): Baseline vs. Day 84 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Paired Wilcoxon Test | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | mITT (n=23): Baseline vs. Day 84 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | <0.001 |
| Comments | ||
| Method | Paired Wilcoxon Test | |
| Comments | ||
| Title | Change From Baseline Over Time in Sleep Efficiency |
|---|---|
| Description | Sleep efficiency for 2 eligible weeks (10 working days) prior to the assessment day was derived from a wrist-worn activity tracker (ActiGraph GT9X Link). Sleep efficiency was defined as the percent of time scored as sleep during the sleep period, from 0% to 100%. Changes were calculated by the formula "Baseline minus Day 28, Day 84, or Day 168." Therefore the resulting negative values reflect deterioration and resulting positive values reflect improvement. |
| Time Frame | Baseline, Days 28, 84, 168 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point. |
| Arm/Group Title | HCV Genotype 1 Participants |
|---|---|
| Arm/Group Description | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
| Measure Participants | 34 |
| Change at Day 28: sdITT Population |
-0.87
(2.50)
|
| Change at Day 28: mITT Population |
-0.44
(2.68)
|
| Change at Day 84: sdITT Population |
-0.06
(2.81)
|
| Change at Day 84: mITT Population |
0.01
(2.98)
|
| Change at Day 168: sdITT Population |
0.61
(3.28)
|
| Change at Day 168: mITT Population |
0.74
(3.37)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | sdITT: mean change Baseline minus Day 168 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | mean change |
| Estimated Value | 0.61 | |
| Confidence Interval |
(2-Sided) 95% -0.651 to 1.871 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | mITT: mean change Baseline minus Day 168 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Method of Estimation | Estimation Parameter | mean change |
| Estimated Value | 0.74 | |
| Confidence Interval |
(2-Sided) 95% -0.608 to 2.088 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | sdITT (n=37): Baseline vs. Day 168 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.381 |
| Comments | ||
| Method | Paired Wilcoxon Test | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | mITT (n=24): Baseline vs. Day 168 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.304 |
| Comments | ||
| Method | Paired Wilcoxon Test | |
| Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | sdITT (n=35): Baseline vs. Day 28 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.014 |
| Comments | ||
| Method | Paired Wilcoxon Test | |
| Comments | ||
Statistical Analysis 6
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | mITT (n=22): Baseline vs. Day 28 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.278 |
| Comments | ||
| Method | Paired Wilcoxon Test | |
| Comments | ||
Statistical Analysis 7
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | sdITT (n=36): Baseline vs. Day 84 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.881 |
| Comments | ||
| Method | Paired Wilcoxon Test | |
| Comments | ||
Statistical Analysis 8
| Statistical Analysis Overview | Comparison Group Selection | HCV Genotype 1 Participants |
|---|---|---|
| Comments | sdITT (n=23): Baseline vs. Day 84 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.775 |
| Comments | ||
| Method | Paired Wilcoxon Test | |
| Comments | ||
| Title | Correlation Coefficients of FSS and Mean Daytime Physical Activity: sdITT Population |
|---|---|
| Description | The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated. |
| Time Frame | Baseline, Days 28, 84, 168 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point. |
| Arm/Group Title | HCV Genotype 1 Participants |
|---|---|
| Arm/Group Description | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
| Measure Participants | 35 |
| Baseline |
0.300
|
| Day 28 |
0.131
|
| Day 84 |
-0.022
|
| Day 168 |
0.195
|
| Title | Correlation Coefficients of FSS and Mean Daytime Physical Activity: mITT Population |
|---|---|
| Description | The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated. |
| Time Frame | Baseline, Days 28, 84, 168 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point. |
| Arm/Group Title | HCV Genotype 1 Participants |
|---|---|
| Arm/Group Description | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
| Measure Participants | 24 |
| Baseline |
0.253
|
| Day 28 |
0.386
|
| Day 84 |
-0.058
|
| Day 168 |
0.128
|
| Title | Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: sdITT Population |
|---|---|
| Description | The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated. |
| Time Frame | Baseline, Days 28, 84, 168 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point. |
| Arm/Group Title | HCV Genotype 1 Participants |
|---|---|
| Arm/Group Description | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
| Measure Participants | 34 |
| Baseline minus Day 28 |
0.228
|
| Baseline minus Day 84 |
-0.044
|
| Baseline minus Day 168 |
0.195
|
| Title | Correlation Coefficients of Change From Baseline Over Time in FSS and Mean Daytime Physical Activity: mITT Population |
|---|---|
| Description | The relationship between the parameters FSS and mean total daytime physical activity as well as for the changes of these parameters between baseline and follow-up visits was analyzed. Given a lake of normal distribution for the FSS data Spearman correlation coefficients were calculated. |
| Time Frame | Baseline, Days 28, 84, 168 |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. Participants with an assessment at given time point. |
| Arm/Group Title | HCV Genotype 1 Participants |
|---|---|
| Arm/Group Description | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
| Measure Participants | 24 |
| Baseline minus Day 28 |
0.135
|
| Baseline minus Day 84 |
-0.065
|
| Baseline minus Day 168 |
0.169
|
| Title | Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) Post-Treatment |
|---|---|
| Description | SVR12 defined as hepatitis C virus ribonucleic acid (HCV RNA) not detectable 12 weeks after the last actual dose of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen). |
| Time Frame | Day 168 (or 12 weeks after the last dose of study drug) |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population: participants who received 3D regimen treatment at least once; scale down ITT (sdITT) population: excluded participants who discontinued or had missing tracker data for all study visits; modified ITT (mITT) population: excluded participants with only partial tracker data sets. |
| Arm/Group Title | HCV Genotype 1 Participants |
|---|---|
| Arm/Group Description | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) |
| Measure Participants | 41 |
| ITT Population |
97.6
238%
|
| sdITT Population |
97.3
237.3%
|
| mITT Population |
95.8
233.7%
|
Adverse Events
| Time Frame | From first dose of study drug up to Day 168 | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | HCV Genotype 1 Participants | |
| Arm/Group Description | Participants receiving paritaprevir/ritonavir/ombitasvir with dasabuvir (Viekirax®/Exviera®, 3D regimen) | |
All Cause Mortality |
||
| HCV Genotype 1 Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/41 (0%) | |
Serious Adverse Events |
||
| HCV Genotype 1 Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/41 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| HCV Genotype 1 Participants | ||
| Affected / at Risk (%) | # Events | |
| Total | 9/41 (22%) | |
| Gastrointestinal disorders | ||
| Nausea | 6/41 (14.6%) | 6 |
| Nervous system disorders | ||
| Dizziness | 3/41 (7.3%) | 3 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | AbbVie |
| Phone | 800-633-9110 |
| abbvieclinicaltrials@abbvie.com |
Responsible Party:
AbbVie
ClinicalTrials.gov Identifier:
NCT03002818
Other Study ID Numbers:
- P16-272
First Posted:
Dec 26, 2016
Last Update Posted:
Oct 23, 2019
Last Verified:
May 1, 2018