This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for 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®) (NCT03002818), a registered phase not stated study. The primary outcome is Change From Baseline at Day 168 in Mean Daytime Physical Activity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03002818 |
| Phase | Phase not stated |
| Condition | Chronic Hepatitis C Virus (HCV) |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 41 |
| Arms in the primary outcome | n/a |
| Lead sponsor | AbbVie |
| Results posted | Yes |
2. Clinical Question
Population
Treatment-naïve participants with hepatitis C virus (HCV) genotype 1 who were suffering from fatigue. The registry record lists chronic HCV as the condition and records enrollment of 41 participants. Further eligibility details are not reported in the registry record.
Intervention
Paritaprevir, ritonavir, and ombitasvir with dasabuvir, referred to as the Viekirax/Exviera or 3D regimen. This was the regimen received by participants in the single study group.
Comparator
There was no separate comparator group. The study is described as single-arm and observational, so the registry record does not provide a randomized or concurrent control-group comparison.
Primary question
How did mean daytime physical activity, measured using wrist actigraphy, change from baseline to Day 168 among participants receiving the 3D regimen? The registry record identifies this question but does not report the numerical change or its uncertainty.
This question concerns change over time within a treated group, not the difference between treatment and control. A before-and-after change can describe what happened during the observation period, but by itself it cannot isolate the contribution of the regimen from other influences. The record also lists fatigue severity, sleep efficiency, correlations between fatigue and activity, and sustained virologic response 12 weeks after treatment among secondary outcomes. Numerical results for these outcomes are not reported in the registry record.
3. Trial Design
HEMATITE was an observational, prospective, open-label, single-arm, multicenter, real-life study. Its stated aim was to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir on total daytime physical activity and fatigue in participants with HCV genotype 1. The registry record lists AbbVie as the sponsor, an enrollment of 41, a start date of 2017-03-01, primary completion on 2018-04-25, and a completed status.
Because the study had one group and no stated randomized allocation, it does not provide a like-for-like control comparison. The primary outcome was a change from baseline at Day 168 in mean daytime physical activity. The record describes activity measurement using a wrist-worn ActiGraph GT9X Link and specifies that activity was assessed over two eligible weeks, defined as 10 working days, before the assessment day. The details of visit timing beyond the stated baseline and Day 168 timeframe are not reported in the registry record.
The listed secondary outcomes cover changes over time in physical activity, fatigue severity, and sleep efficiency; correlations between fatigue severity and activity; correlations between changes in those measures; and the percentage of participants with sustained virologic response 12 weeks after treatment. The registry record lists nine outcome measures and 24 analyses. It does not report the numerical outcome findings, the statistical analysis plan, the rationale for the enrollment target, or whether any interim analyses were planned.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Hepatitis C Virus (HCV) Genotype 1 Participants |
|---|---|
| STARTED | 41 |
| COMPLETED | 40 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | Hepatitis C Virus (HCV) Genotype 1 Participants |
|---|---|
| Decision of the investigator | 1 |
Analysis population for the primary outcome, as defined in the registry: 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.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | HCV Genotype 1 Participants |
|---|---|---|
| Participants analysed | 41 | |
| Age, Continuous | years | 49.4 (SD 12.7) |
| Sex: Female, Male: Female | Participants | 27 |
| Sex: Female, Male: Male | Participants | 14 |
| Race/Ethnicity, Customized: Caucasian | Participants | 41 |
| Mean Daytime Physical Activity: sdITT Population | day-counts | 1469569 (SD 405329) |
| Mean Daytime Physical Activity: mITT Population | day-counts | 1513166 (SD 410686) |
| Fatigue Severity Scale (FSS): sdITT Population | score on a scale | 5.95 (SD 0.61) |
| Fatigue Severity Scale (FSS): mITT Population | score on a scale | 5.94 (SD 0.67) |
| Sleep Efficiency: sdITT Population | percent of time asleep | 89.4 (SD 4.58) |
| Sleep Efficiency: mITT Population | percent of time asleep | 89.8 (SD 3.76) |
6. Primary Endpoint
The registry lists the primary outcome as Change From Baseline at Day 168 in Mean Daytime Physical Activity, measured over Baseline, Day 168.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | day-counts |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the change from baseline at Day 168 in mean daytime physical activity, measured in day-counts. The registry record states that a wrist-worn ActiGraph GT9X Link measured movement using a 3-axis algorithm. For total daytime physical activity, the tracker’s measured activity counts were adjusted by subtracting total sleep counts. The measure was derived from two eligible weeks, or 10 working days, before each assessment day. Higher day-counts signify more activity.
This endpoint offers a device-based way to quantify activity across multiple days rather than relying only on a participant’s recollection of activity. Repeated measurement can describe whether recorded activity changed between baseline and the later assessment. It does not, by itself, explain why activity changed. In general, a measurement’s usefulness depends on how consistently it captures the construct of interest and how well the measurement period represents the participant’s usual activity. The registry record describes the device and calculation but does not report measurement validation results or the primary endpoint’s observed change.
The endpoint is a mean of a continuous measure, with standard deviation identified as the dispersion measure. The actual mean, standard deviation, analysis denominator, and uncertainty around the baseline-to-Day-168 change are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The primary outcome is framed as a within-group change in mean daytime physical activity from baseline to Day 168. That framing matters: the study record describes one group receiving the 3D regimen, not a separate control group. A change over time can be informative about the group’s observed trajectory, but it does not establish what would have happened to the same participants over the same period without the regimen. Other time-related influences cannot be separated from treatment effects using a single-arm comparison alone.
The registry record does not report the numerical primary outcome change, its direction, its standard deviation, a confidence interval, or a statistical test result. Therefore, the magnitude and precision of the recorded activity change cannot be assessed from the registry information. The same limitation applies to the listed secondary outcomes: their names are recorded, but their numerical results are not reported in the registry record. No conclusion about the size or statistical uncertainty of those outcomes follows from the outcome titles alone.
In general, a confidence interval describes a range of values compatible with the data and the assumptions of the analysis. A narrow interval indicates greater statistical precision than a wide interval, but precision is not the same as protection against bias. In an uncontrolled observational study, even a precise estimate of within-group change would not by itself establish that the regimen caused that change.
The record describes an enrollment of 41, but does not report the number included in the primary analysis or the amount of missing endpoint data. Enrollment should not be treated as the analysis denominator unless the record explicitly establishes that all enrolled participants contributed to that analysis. The population descriptions identify ITT, scale down ITT, and modified ITT definitions, but the record does not state which population produced the primary result or provide population-specific results.
Accordingly, the posted record supports a description of the study question, measurement approach, and design. It does not support a quantitative interpretation of the primary or secondary findings. The absence of numerical results in the registry record is not evidence that there was no change; it means the change and its uncertainty are not reported there.
9. Statistical Methods Explained
The registry record describes a continuous primary measure: mean daytime physical activity in day-counts. It identifies standard deviation as the dispersion measure and baseline and Day 168 as the primary timeframe. The numerical summary statistics and the method used to compare the two time points are not reported in the registry record.
What does a mean describe?
In general, a mean is the arithmetic average of observed values. It gives a central summary of a group’s measurements, but it does not show how individual measurements are distributed. The standard deviation describes the spread of observations around the mean. A larger standard deviation indicates more variability among observed values, while a smaller one indicates values are more clustered around the mean. Neither statistic alone describes the precision of an estimated change; precision also depends on the number of observations contributing to the analysis and on the analysis method. The registry record does not report the primary mean, its standard deviation, or the analysis count.
How should change from baseline be understood?
In general, a change score compares a later measurement with a baseline measurement. It can be expressed as a group-level change in means or as an average of participant-level changes; those approaches need not yield identical estimates when the available observations differ. The registry record names a change from baseline at Day 168 but does not explain the exact calculation or statistical model used. It also does not report whether the analysis adjusted for baseline values or other covariates.
For a within-group change, the interpretation is descriptive unless a design and analysis support a causal comparison. In general, the observed change can reflect the intervention, natural variation over time, measurement variability, changes in participant circumstances, or other influences. A control group can help distinguish treatment-related change from background change, but HEMATITE is described as single-arm and does not list a control group.
Why can variability matter?
In general, variability affects how precisely a mean or change is estimated. When observations vary substantially, an estimate may be less precise than when measurements are more tightly clustered, all else being equal. Some data are more variable than a simple statistical model assumes; this is called over-dispersion. If over-dispersion is present, a model that assumes less variability can produce uncertainty estimates that are too small. The registry record does not report whether over-dispersion was assessed or whether a model that allows for it was used.
What do the planning calculations represent?
The planning illustrations use the observed effect as a reference and consider detecting stated fractions of that effect. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These calculations are hypothetical planning illustrations, not observed power for the completed single-arm study. They do not change the design into a two-arm comparison and should not be read as evidence that the study had a particular probability of finding an effect. The registry record does not report a sample-size justification from the study’s original design or identify these illustrations as its protocol plan.
What is not available about inference?
In general, a statistical test assesses how compatible observed data are with a specified null hypothesis under stated assumptions. A p-value does not measure the probability that a treatment works, nor does it describe the size or practical importance of an effect. A confidence interval is useful alongside a point estimate because it conveys uncertainty in the estimated quantity. Neither a p-value nor an interval can resolve the lack of a control group for causal interpretation.
The registry record does not report a primary estimate, confidence interval, p-value, model specification, covariate adjustment, or variance assumptions. It also does not report a prespecified statistical analysis plan. Statistical significance, effect magnitude, and precision therefore cannot be evaluated from the registry results.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists multiple outcomes and 24 analyses. These include the primary activity change and secondary measures of physical activity, fatigue severity, sleep efficiency, correlations between measures, and sustained virologic response 12 weeks after treatment. When many outcomes or analyses are considered, the chance of at least one apparently unusual result can increase. In general, multiplicity procedures can control that risk, but the choice depends on which comparisons were planned and how they were prioritized. A multiplicity adjustment or hierarchy is not reported in the registry record.
The record describes three analysis populations. The ITT population includes participants who received the 3D regimen at least once. The scale down ITT population excludes participants who discontinued or had missing tracker data for all study visits. The modified ITT population excludes participants with only partial tracker data sets. These definitions indicate that tracker-data availability and discontinuation affected population membership, but the registry record does not provide analysis counts for these populations or identify which one was used for each reported outcome.
The record does not describe how missing data were handled in the analyses, whether missingness was assessed, or whether sensitivity analyses were conducted. In general, excluding participants with incomplete measurements can change the composition of the analyzed group; the direction and size of any resulting bias depend on why data are missing and on the analysis. No specific missing-data mechanism can be inferred from the population definitions alone.
For these reasons, the number of listed analyses should not be taken as evidence that any particular adjustment was or was not applied, and the population labels do not establish the analysis denominator. Those details are not reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| HCV Genotype 1 Participants | 0 | 41 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| HCV Genotype 1 Participants | 0 of 41 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| HCV Genotype 1 Participants | 9 of 41 |
Most frequent non-serious adverse event terms
| Event term | Organ system | HCV Genotype 1 Participants |
|---|---|---|
| Nausea | Gastrointestinal disorders | 6 of 41 |
| Dizziness | Nervous system disorders | 3 of 41 |
The registry record lists 41 participants at risk for serious adverse events and zero participants affected. It lists 41 at risk for other adverse events and nine affected. It records zero deaths and no serious adverse-event terms in the serious-event listing. These are registry counts; the record does not provide event descriptions, timing, duration, severity details for the other-event category, or participant-level follow-up information.
In general, “at risk” is the denominator associated with the record’s safety count, while “affected” identifies the count recorded with an event in that category. A zero count for serious adverse events means none were recorded in that category in the registry entry. It does not establish that the regimen carries no serious-event risk. The interpretation of safety counts depends on how events were defined, collected, and followed, and on the amount of observation time. Such details are not reported in the registry record.
The counts also do not provide a comparison with an untreated or alternative-treatment group. As this is a single-arm study, the safety figures describe the registry’s recorded experience in that group rather than a comparative estimate of risk.
12. What the Result Does, and Does Not, Mean
The study addresses a patient-relevant measurement question: whether device-recorded daytime physical activity changed over time among treatment-naïve participants with HCV genotype 1 and fatigue who received the 3D regimen. It also lists fatigue severity, sleep efficiency, correlations between fatigue and activity, and sustained virologic response 12 weeks after treatment as secondary topics. Using a wrist-worn activity tracker gives the primary outcome an objective measurement component, and the stated measurement period draws on multiple working days before an assessment.
However, the registry record does not report the numerical primary or secondary findings. It therefore does not allow readers to assess the direction, magnitude, or precision of the activity change, or the results for fatigue and the other listed outcomes. The absence of those results in the registry record should not be interpreted as a null result.
The design also places limits on causal interpretation. Because the study is described as observational and single-arm, it has no concurrent control group for separating changes associated with receiving the regimen from other changes over time. The record does not describe randomized allocation, and it does not report an analysis plan that could resolve that design limitation.
In general, statistical evidence about change is strongest when the estimated effect, its uncertainty, the analysis population, and the handling of missing observations are all clear. Those details are not reported in the registry record for the primary endpoint. The record can therefore establish what the study intended to observe and how its main activity measure was defined, but it cannot establish the size or certainty of the observed change or attribute any change to treatment.
13. Why This Trial Matters Statistically
This study is statistically notable for pairing a patient-centered topic—fatigue and daily activity—with wrist-actigraphy measurement in a real-life, multicenter observational setting. The primary measure is explicitly defined in day-counts, including how sleep counts were removed and the period used before assessment. Clear measurement definitions help readers understand what an outcome represents and what a change would mean in the scale’s terms.
The single-arm design is equally important to interpreting the question. The study is suited to describing observations over time in participants receiving the regimen, but without a control group it cannot distinguish treatment-related change from background changes or other influences. This is a design limitation, not a statistical detail that can be repaired merely by selecting a different test.
The record also names multiple secondary outcomes and analysis populations. That makes transparent reporting of analysis denominators, missing-data handling, and multiplicity methods particularly relevant. Those details, along with numerical results for the primary and secondary outcomes, are not reported in the registry record. Their absence limits an independent assessment of precision and the risk of selective emphasis across analyses.
The statistical value of the record is therefore primarily in its description of the question, measurement strategy, and design. It also illustrates why outcome definitions and design context must be considered together: a carefully described measurement can support interpretation of what was assessed, while a single-arm structure still limits what can be concluded about causes of change.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct limitation for interpreting results is that the registry record does not report the numerical primary outcome estimate or its uncertainty. It also does not report numerical findings for the listed secondary outcomes. Readers therefore cannot judge the magnitude or precision of activity change, or examine how fatigue, sleep efficiency, correlations, and sustained virologic response varied in the study.
The single-arm observational design has no concurrent comparator, so within-group change cannot by itself establish a treatment effect. The record describes the study as prospective, open-label, multicenter, and real-life, but does not provide details about recruitment, site-level variation, participant characteristics beyond the stated population, or follow-up completeness. These details are not reported in the registry record.
Although the record defines ITT, scale down ITT, and modified ITT populations, it does not report the analysis denominator for the primary outcome or explain which population was used for each analysis. It does not describe missing-data methods, sensitivity analyses, model assumptions, covariate adjustment, or multiplicity handling. These omissions constrain assessment of bias and statistical precision.
The activity endpoint is based on tracker data gathered over a specified pre-assessment period, but the registry record does not report adherence to wearing the tracker, the amount of usable data, or measurement validation results in this study. The enrollment of 41 should not be assumed to equal the number analyzed. Further protocol details and the rationale for the enrollment target are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: 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®) — NCT03002818.
- Registry record last updated 2019-10-23; status last verified 2018-05.
- Results first posted 2019-10-23.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
HEMATITE (NCT03002818) is a completed, prospective, open-label, single-arm observational study sponsored by AbbVie. The registry record lists an enrollment of 41 and describes treatment-naïve participants with HCV genotype 1 suffering from fatigue who received paritaprevir/ritonavir/ombitasvir with dasabuvir.
The primary outcome was change from baseline at Day 168 in mean daytime physical activity, measured in day-counts using a wrist-worn ActiGraph GT9X Link. The record also lists secondary outcomes relating to fatigue, sleep efficiency, activity-fatigue correlations, and sustained virologic response. Numerical results for the primary and secondary outcomes, analysis denominators, and several analysis details are not reported in the registry record.
The single-arm design supports description of change over time but does not provide a concurrent control comparison. The registry lists zero participants affected by serious adverse events, nine affected by other adverse events, and zero deaths.