Comparison · NCT02549170-94e44d01
Epoch 1: Placebo With rHuPH20 vs Epoch 1: HYQVIA/HyQvia: Epoch 1: Number of Participants Who Develop Binding and/or Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Epoch 1: Placebo With rHuPH20 vs Epoch 1: HYQVIA/HyQvia: Epoch 1: Number of Participants Who Develop Binding and/or Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20). Trial comparisons, record NCT02549170-94e44d01. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02549170-94e44d01
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.1 | 0.0493 | 0.192 | wilson | |
| Risk in group 2 | 0.0161 | 0.00285 | 0.0859 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0839 | -0.00236 | 0.177 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 6.2 | 0.785 | 49 | log | |
| Odds ratio, group 1 over group 2 | 6.78 | 0.81 | 56.7 | log | |
| Number needed to treat, for one more participant with the outcome on Epoch 1: Placebo With rHuPH20 than on Epoch 1: HYQVIA/HyQvia | 11.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Epoch 1: Placebo With rHuPH20 | Participants received rHuPH20 80 U/10 mL solution, followed by SC placebo infusion at matching infusion volume as per the participant's pre-randomization monthly equivalent IG dose when administered every 2, 3, or 4 weeks for 31.54 weeks or until relapse. | 7 | 70 | OG000 |
| Group 2 | Epoch 1: HYQVIA/HyQvia | Participants received HYQVIA/HyQvia (rHuPH20) 80 U/g IG, followed by SC injection of immunoglobulin (IGI) 10% at the same monthly equivalent IG dose as per the individual participant's pre-randomized IG dose when administered every 2, 3, or 4 weeks for 30.28 weeks or until relapse.. | 1 | 62 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Epoch 1: Number of Participants Who Develop Binding and/or Neutralizing Antibodies to Recombinant Human Hyaluronidase (rHuPH20)
- Description
Number of participants who developed binding and/or neutralizing antibodies to rHuPH20 in Epoch 1 were reported. High-binding antibodies is defined as number of participants who had at least one anti-rHuPH20 antibody titer ≥1:160 during treatment.
- Time frame
- Week 32 (EOET1)/UV/ET
- Population
- Epoch 1 safety analysis set included all participants who received any study treatment.
Source ClinicalTrials.gov
Trial
- Title
- A Study of HyQvia and Gammagard Liquid (Kiovig) in Adults With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
- NCT number
- NCT02549170
- Phases
- PHASE3
- Conditions
- Chronic Inflammatory Demyelinating Polyradiculoneuropathy
- Interventions
- HYQVIA, 0.25% albumin placebo solution with rHuPH20, IGIV GAMMAGARD LIQUID/KIOVIG, IGIV GAMUNEX®-C
- Lead sponsor
- Baxalta now part of Shire
- Results first posted
- 2023-05-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02549170?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02549170-94e44d01