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 Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients (NCT00998426), a na phase 4 study. The primary outcome is Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00998426 |
| Phase | Phase 4 |
| Condition | Hepatitis B |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 5 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Georgetown University |
| Results posted | Yes |
2. Clinical Question
Population
Post-liver transplant patients receiving HepaGam B. The registry record lists an enrollment of 5 and says procedures took place once between post-op day 1 and post-op day 7.
Intervention
HepaGam B, a hepatitis B immune globulin infusion. The record notes that the solution contains 10% maltose, which could possibly interfere with glucose measurement by non-specific tests.
Comparator
There is no separate control group. Each participant's glucose measurements before infusion are compared with measurements after infusion, using non-specific point-of-care, specific point-of-care, and venous blood methods.
Primary question
How do glucose measurements from the three methods differ before and after HBIG injection, including immediately after injection and at 60 min and 120 min?
The study focuses on measurement during an infusion rather than a randomized comparison of treatments. Its practical statistical question is whether glucose values recorded by a glucose-non-specific point-of-care method change in relation to the infusion, and how those readings compare with a glucose-specific point-of-care method and venous blood measurements. The registry describes this as an evaluation of blood glucose levels during HepaGam B administration.
The distinction between a change in a reading and a change in glucose itself is central. The registry's rationale is that maltose in the solution could possibly affect a glucose-non-specific test. A discrepancy between methods might therefore reflect measurement behavior rather than a corresponding change in the body's glucose level. The study includes multiple methods to examine that issue, but the registry record does not report their observed results.
3. Trial Design
This is a Phase 4, completed, single-group study sponsored by Georgetown University. The registry lists enrollment of 5. Allocation is recorded as NA, masking as none, and the model as single group. There is no randomized control arm or like-for-like comparison group described in the record. The study began in 2009-10, with primary completion in 2011-09.
The study procedures were planned once for each participant between post-op day 1 and post-op day 7. Glucose was measured before HBIG injection and after infusion, at the times specified in the primary outcome: immediately following injection, 60 min after dose, and 120 min after dose. The listed procedures include glucose monitoring before and after HepaGam B administration; the biological intervention is HepaGam B, also called hepatitis B immune globulin.
All participants were to have measurements by glucose-non-specific point-of-care testing (GNS-POC), glucose-specific point-of-care testing (GS-POC), and venous blood. This within-participant measurement plan can support comparisons across methods and times. It does not, by itself, separate changes associated with the infusion from changes over time or other influences, because the record does not describe an uninfused control condition or another comparator group.
The registry record does not report a protocol for allocation, a masking procedure, a sample-size justification, interim analyses, or a detailed statistical analysis plan. The planning illustration described with the posted results uses a two-arm equal-allocation framework; that framework is not the design described for this single-group study and should not be read as evidence that participants were assigned to two arms.
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 | All Study Participants |
|---|---|
| STARTED | 5 |
| Blood Glucose Monitoring | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
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 | All Study Participants |
|---|---|---|
| Participants analysed | 5 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 5 |
| Age, Categorical: >=65 years | Participants | 0 |
| Age, Continuous | years | 48 (SD 8) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 3 |
| Region of Enrollment: United States | participants | 5 |
| adult OLT recipients | participants | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Differences in Blood Glucose Levels as Measured by GNS-POC, GS-POC and Venous Blood Prior to and After HBIG Injection, measured over Pre-dose, immediately following, 60 min and 120 min after injection.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mg/dL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the difference in blood glucose levels measured by GNS-POC, GS-POC, and venous blood before and after HBIG injection. The registry identifies the measure as a mean with standard deviation, uses mg/dL as the unit, and specifies measurements pre-dose, immediately following injection, and at 60 min and 120 min after injection.
These methods address the study's measurement concern. The registry says HepaGam B contains 10% maltose and that maltose could possibly interfere with glucose-non-specific tests. Comparing a non-specific point-of-care reading with a specific point-of-care reading and venous blood can help characterize whether readings differ across methods around the infusion. Such comparisons are useful because a device reading is not automatically equivalent to the underlying glucose level when the measurement method may be susceptible to interference.
In general, a mean describes the central value of measurements, while a standard deviation describes their spread. For measurements taken repeatedly from the same participant, the relationship between that participant's readings across times and methods is also important when estimating uncertainty. The registry record does not report the actual means, standard deviations, method-specific differences, or inferential results. It therefore describes what the endpoint was intended to measure, but does not allow the observed size or precision of any change to be assessed.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a focused measurement question, but it does not report the glucose outcome values. There are no posted mean glucose levels, standard deviations, differences, confidence intervals, or p-values in the record described for this analysis. As a result, the direction, magnitude, and precision of any observed change cannot be stated. The sponsor's belief that the medication would not cause a significant increase when measured by glucose-non-specific tests is a stated expectation, not a reported study result.
The endpoint calls for measurements by three methods at pre-dose and after dose. If results are displayed by method and time, interpretation should distinguish within-method change from disagreement between methods. A rise in a non-specific device reading alone would not establish that glucose itself rose; the specific point-of-care and venous blood readings are relevant comparators for evaluating measurement behavior. Conversely, agreement among methods would not by itself establish a causal effect of infusion, because the study has no separate control group described in the record.
The small enrollment of 5 is important context for precision. With a small study, estimates can be sensitive to individual observations, and uncertainty may be substantial. This is a general statistical consideration, not a claim about the study's unreported estimates. Without the observed results and their uncertainty, it is not possible to determine how compatible the data are with different sizes or directions of change.
The study is single group, unmasked, and has allocation recorded as NA. Accordingly, its design is suited to describing measurements around the infusion, not to a randomized treatment-effect comparison. The measurement times can reveal how readings behave across the specified observation period, but they do not establish what would have happened over the same period without infusion.
Safety entries report 0 serious adverse events and 0 other adverse events in both the Acute Phase and Chronic Phase groups, each listed with 5 at risk. These registry counts should be read as the reported event figures for those categories and groups. Death counts are not reported in the registry record. The safety entries do not supply additional detail about surveillance, event definitions, or follow-up beyond the labels shown.
Any planning calculations based on an observed effect should not be mistaken for observed power or for the trial's original design. The registry describes a planning illustration using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Because the trial itself is recorded as single group, those assumptions do not describe its allocation. Numerical planning outputs and the outcome effect on which they depend are not reported in the registry record.
9. Statistical Methods Explained
What does the endpoint estimate? The endpoint is continuous: glucose concentration in mg/dL. The registry specifies the mean and standard deviation, with measurements from GNS-POC, GS-POC, and venous blood at pre-dose and after injection. In general, a mean gives a compact description of the center of a set of values. A standard deviation describes how spread out those values are around the mean. Neither alone describes how much an individual participant's reading changed, and neither establishes whether the change is statistically distinguishable from random variation.
Why do the measurement methods matter? The study's rationale is possible interference from maltose in a glucose-non-specific test. In general, a method comparison asks whether two measurement procedures produce similar values or systematically different readings under the same conditions. Here, the protocol's three methods make it possible to examine that issue across the stated times. A difference between methods is not automatically evidence of a biological change: it may reflect measurement characteristics, timing, or other influences. The record does not report method-agreement estimates or a specific method-comparison analysis.
How should repeated readings be considered? Measurements before and after infusion come from the same participants. In general, readings from the same person are related; treating them as if they came from unrelated people can misrepresent uncertainty. A paired analysis uses each participant's change or otherwise accounts for the within-person relationship. When multiple post-dose times are included, the analysis may also need to account for correlation among repeated readings. The registry record does not report whether a paired method, repeated-measures model, or another approach was used.
What does a confidence interval add? In general, a confidence interval expresses the uncertainty around an estimated quantity, such as a mean difference. It helps show which effect sizes remain reasonably compatible with the data under the method's assumptions. A point estimate alone does not show precision. The record does not report confidence intervals for the primary endpoint, so the precision of the glucose comparisons cannot be evaluated from the registry description.
What does a p-value add? In general, a p-value measures how unusual results at least as incompatible with a specified null hypothesis would be if that hypothesis and the statistical model were true. It does not measure the probability that the null hypothesis is true, the size of an effect, or whether a difference matters clinically. The registry record does not report a p-value or a prespecified hypothesis test for the primary outcome. The sponsor's stated expectation is not a substitute for an analysis result.
Why is the design relevant to inference? A single-group before-and-after design can describe temporal patterns and within-person changes. In general, however, a change over time may also reflect influences other than the intervention. A control condition can help distinguish those possibilities, while random allocation can help make groups comparable in expectation. This record lists a single-group model, allocation NA, and no masking; it does not describe a control arm. Therefore, the study's design does not support the same causal interpretation as a randomized controlled comparison.
How should multiple comparisons be treated? The endpoint includes three methods and measurements at several times. In general, examining multiple outcomes or contrasts creates more opportunities for an apparently notable result by chance. A prespecified primary contrast or a multiplicity adjustment can help control the interpretation of a family of tests. The registry record does not report a multiplicity strategy or identify a single contrast among the listed methods and times as the sole inferential comparison. This absence means the analysis approach cannot be evaluated from the registry entry.
What does the planning illustration mean? The described planning assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect set as a stated fraction of an observed effect. In general, a sample-size calculation estimates the number of participants needed under specified assumptions to target a level of power for detecting an effect. It is a planning exercise, not evidence that a study had that power after completion. The registry labels the calculation as a planning illustration, not the trial's own design. Its two-arm assumption also differs from the recorded single-group design. Numerical planning outputs and the observed effect used for the illustration are not reported in the registry record.
What can be said about distributional assumptions? A normal approximation may be used in some continuous-outcome analyses, but its suitability depends on the data and analysis. In general, skewness, outliers, and unequal variability can affect the performance of methods based on normality. The registry does not report the glucose distributions or diagnostics. No conclusion about those assumptions can therefore be drawn from the record.
Overall, the methods described define a repeated measurement study intended to compare glucose readings around HBIG infusion. The registry record does not report enough outcome or analysis detail to reproduce the estimates or judge their statistical uncertainty. Methods explanations above are general statistical context, not a claim that any particular analysis was performed.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint involves three measurement methods—GNS-POC, GS-POC, and venous blood—and measurements at pre-dose, immediately following injection, and 60 min and 120 min after dose. Considering multiple methods and times can produce multiple possible comparisons. In general, the more comparisons examined, the greater the need to distinguish prespecified primary contrasts from exploratory ones and to consider multiplicity when interpreting statistical tests. A multiplicity adjustment or hierarchy of comparisons is not reported in the registry record.
The record does not report whether any measurements were missing, how missing values were handled, or whether participants with incomplete measurements were excluded from particular analyses. It also does not report the analysis population definition, such as whether the primary analysis included all enrolled participants or only those with complete measurements. These omissions prevent assessment of whether the reported analysis, if any, could have been affected by missingness or exclusions.
Detailed statistical methods are not reported in the registry record. In particular, the record does not specify a model for repeated measurements, a method for comparing the measurement devices, a prespecified primary contrast, an approach to multiplicity, or an inferential procedure for the endpoint. The endpoint's mean and standard deviation describe intended summaries, but do not establish which test or model was used. The posted results do not include the numerical outcome estimates needed to assess these choices.
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 |
|---|---|---|---|
| Acute Phase | 0 | 5 | 0.0% |
| Chronic Phase | 0 | 5 | 0.0% |
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 |
|---|---|
| Acute Phase | 0 of 5 |
| Chronic Phase | 0 of 5 |
The registry lists safety figures separately for Acute Phase and Chronic Phase. In each group, 5 participants are listed as at risk, with 0 serious adverse events and 0 other adverse events. These are the event counts recorded for those categories. They should not be combined into a new total or interpreted as a complete account of every possible safety outcome.
The registry record does not report death counts for these groups; deaths are not reported in the registry record. It also does not provide further detail about adverse-event definitions, monitoring procedures, event timing, or how the Acute Phase and Chronic Phase group labels relate to participant follow-up. The figures therefore describe what was entered in the registry, while leaving those contextual details unspecified.
Zero recorded events in a small study do not establish that an event cannot occur or precisely characterize its frequency. In general, safety estimates based on limited observations have substantial uncertainty, particularly for uncommon events. The figures are descriptive registry entries, not proof of absence of risk and not a comparison against a control group.
12. What the Result Does, and Does Not, Mean
The study addresses a relevant measurement question: whether glucose readings around HepaGam B infusion differ across non-specific point-of-care, specific point-of-care, and venous blood methods. The registry explains why this question was considered: the solution contains 10% maltose, which could possibly interfere with glucose measurement by non-specific tests. The planned measurements span the pre-dose period and specified post-dose times.
However, the registry record does not report the observed glucose means, standard deviations, differences, confidence intervals, or p-values. It therefore does not establish whether readings rose, fell, remained similar, or differed between methods. The sponsor's stated belief about the expected findings is not evidence of the observed outcome. Without the outcome data, the magnitude and precision of any measurement change cannot be assessed.
The single-group design is suitable for describing readings before and after infusion, but it lacks a separate control group. A before-and-after pattern alone cannot show that infusion caused a change, since other time-related influences may also affect measurements. In addition, a change in a device reading is not necessarily the same as a change in glucose itself, particularly when possible test interference motivates the study.
The registry reports enrollment of 5. That small enrollment limits how much can be inferred about the range of responses or the precision of estimates. More importantly, the registry entry does not supply the numerical outcome results needed to judge the observed data. The responsible conclusion is therefore about the study's question and design, not about whether HepaGam B changed glucose levels or whether the different measurement methods agreed.
13. Why This Trial Matters Statistically
This trial matters statistically because it illustrates the difference between a biological quantity and the instrument reading used to measure it. The registry identifies a plausible measurement concern: maltose in the HBIG solution could possibly interfere with glucose-non-specific tests. Including GNS-POC, GS-POC, and venous blood measurements recognizes that the method used can affect how a value should be interpreted.
It also highlights the value and limits of repeated measurements. Measuring participants before and after infusion allows within-person descriptions, which can be informative when readings from the same person are related. Yet repeated observations do not replace a control condition. Without one, temporal change cannot be attributed uniquely to the infusion. A small single-group study may help frame a measurement question, but its design does not supply the causal comparison of a randomized trial.
Finally, this record shows why statistical interpretation requires more than a stated objective and a planned endpoint. Means and standard deviations are named, but the registry does not report the actual values, uncertainty intervals, or inferential analysis. Nor does it describe missing-data, multiplicity, or repeated-measure methods. The result is a clear account of the intended measurement schedule but insufficient information to judge the size, precision, or statistical significance of any observed effect. That distinction is important when registry entries are used to understand what a study can and cannot establish.
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 primary limitation for interpreting the outcome is that the registry record does not report numerical glucose results. Means, standard deviations, method-specific differences, confidence intervals, and p-values are not reported in the registry record. Without those results, readers cannot assess the direction, size, or precision of the measurement changes.
The study is recorded as single group, with allocation NA and masking none. There is no separate comparator arm described. Accordingly, before-and-after observations cannot isolate an infusion effect from other influences that could vary over time. The enrollment is 5, which also limits the information available about variability and the range of participant responses.
The protocol description specifies measurement methods and times, but the registry record does not report detailed methods for analyzing repeated measurements or comparing devices. It does not state whether observations were paired in the analysis, how multiple method-and-time comparisons were handled, or whether any multiplicity procedure was used. Missing-data handling and analysis-population definitions are also not reported in the registry record.
The record does not report a sample-size justification, interim analyses, or a full statistical analysis plan. A separate planning illustration is described with two-arm equal-allocation assumptions, whereas the trial is recorded as single group; the illustration should not be read as a description of the study's design or as observed power. The safety entries give event counts, but further information about definitions, follow-up, and death counts is not reported in the registry record. These limitations constrain both efficacy-oriented interpretation of the measurement endpoint and broader safety conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluating Blood Glucose Levels During Infusion With HepaGam B (HBIG) in Post-liver Transplant Patients — NCT00998426.
- Registry record last updated 2015-09-28; status last verified 2015-04.
- Results first posted 2015-09-28.
- 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
NCT00998426 is a completed Phase 4, single-group study sponsored by Georgetown University. It lists enrollment of 5 and evaluates glucose measurements around HepaGam B administration in post-liver transplant patients. Measurements were planned before injection and immediately after, at 60 min, and at 120 min, using GNS-POC, GS-POC, and venous blood methods.
The stated rationale concerns possible interference from the solution's 10% maltose content with glucose-non-specific testing. The primary endpoint is described in terms of mean glucose levels and standard deviations in mg/dL. The record reports no numerical primary outcome results or detailed statistical analysis, so the observed changes and their precision cannot be assessed. Safety entries list 0 serious and 0 other adverse events in each of the Acute Phase and Chronic Phase groups; death counts are not reported in the registry record.