Trial · NCT02210091
BAX 855 Pediatric Study
NCT02210091, Phase 3, Completed, Baxalta now part of Shire; results first posted 2016-12-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BAX 855 Pediatric Study. Trials, record NCT02210091. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02210091
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BAX 855 Pediatric Study
- NCT number
- NCT02210091
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 75 participants, actual
- Lead sponsor
- Baxalta now part of Shire
- Conditions
- Hemophilia A
- Interventions
- Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method, PEGylated Recombinant Factor VIII, PEGylated Recombinant Factor VIII
- First posted
- 2014-08-06
- Last updated
- 2021-05-24
- Other registries' IDs
- eudract:2014-000742-30
- Results first posted
- 2016-12-05
Source ClinicalTrials.gov
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII) | After first exposure to BAX 855 until completion of study - approx. 6 months per participant. | Inhibitory antibodies to FVIII were measured using the Nijmegen modification of the Bethesda assay. Incidence of an FVIII inhibitory antibody was defined as an inhibitor level ≥0.6 Bethesda units \[BU\]. |
| Secondary | Annualized Bleeding Rate (ABR) | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | The annualized bleeding rate (ABR) during the prophylaxis period was assessed based upon each individual bleeding episode, spontaneous or traumatic, recorded in the participant´s diary and/or recorded in the physician/nurse/study site notes. The annualized bleeding rate was analyzed using a generalized linear model framework assuming a negative binomial distribution with a logarithmic link function and presence or absence of target joints and age cohort as covariates and duration of the observation period in years as offset. Point estimates for the mean and 95% confidence intervals are presented. |
| Secondary | Consumption of BAX 855: Number of Prophylactic Infusions Per Month Per Participant | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | |
| Secondary | Consumption of BAX 855: Number of Prophylactic Infusions Per Year (Annualized) Per Participant | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | |
| Secondary | Consumption of BAX 855: Weight-adjusted Dose of Prophylactic Infusions Per Month Per Participant | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | |
| Secondary | Consumption of BAX 855: Weight-adjusted Dose of Prophylactic Infusions Per Year (Annualized) Per Participant | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | |
| Secondary | Consumption of BAX 855: Number of Infusions Per Bleeding Episode | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | |
| Secondary | Consumption of BAX 855: Weight-adjusted Dose Per Bleeding Episode | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | |
| Secondary | Hemostatic Efficacy Rating for Bleeding Episodes Treated With BAX 855 at Resolution of Bleed | After first exposure to BAX 855 until completion of study - approx. 6 months per participant. | Rating Scale for Treatment of Bleeding Episodes (BEs) (4-point ordinal scale): Excellent: Full relief of pain and cessation of objective signs of bleeding (eg, swelling, tenderness, and decreased range of motion in the case of musculoskeletal hemorrhage) after a single infusion. No additional infusion required for the control of bleeding. Administration of further infusions to maintain hemostasis did not affect this scoring. Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion. Possibly requires more than 1 infusion for complete resolution. Fair: Probable and/or slight relief of pain and slight improvement in signs of bleeding after single infusion. Required more than 1 infusion for complete resolution. None: No improvement or condition worsens. |
| Secondary | Serious Adverse Events (SAEs) Possibly or Probably Related to BAX 855 | After first exposure to BAX 855 until completion of study - approx. 6 months per participant. |
1 to 10 of 23Source ClinicalTrials.gov
See all 23 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII) | After first exposure to BAX 855 until completion of study - approx. 6 months per participant. | Participants in the BAX 855 Safety Analysis Set who developed an inhibitor at any time plus participants who did not develop an inhibitor, had 50 or more exposure days (EDs) to BAX 855 and had FVIII Inhibitory test results after 50 EDs. | participants | NUMBER |
| SECONDARY | Annualized Bleeding Rate (ABR) | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | Full Analysis Set: All participants who received at least 1 dose of BAX 855 in either PK or prophylaxis part of study | bleeding episodes per year | MEAN |
| SECONDARY | Consumption of BAX 855: Number of Prophylactic Infusions Per Month Per Participant | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | BAX 855 Safety Analysis Set. | infusions per month | MEAN |
| SECONDARY | Consumption of BAX 855: Number of Prophylactic Infusions Per Year (Annualized) Per Participant | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | BAX 855 Safety Analysis Set. | infusions per year | MEAN |
| SECONDARY | Consumption of BAX 855: Weight-adjusted Dose of Prophylactic Infusions Per Month Per Participant | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | BAX 855 Safety Analysis Set. | IU/kg | MEAN |
| SECONDARY | Consumption of BAX 855: Weight-adjusted Dose of Prophylactic Infusions Per Year (Annualized) Per Participant | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | BAX 855 Safety Analysis Set. | IU/kg | MEAN |
| SECONDARY | Consumption of BAX 855: Number of Infusions Per Bleeding Episode | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | Participants in the BAX 855 Safety Analysis Set who had treated bleeding episodes. | infusions | MEAN |
| SECONDARY | Consumption of BAX 855: Weight-adjusted Dose Per Bleeding Episode | During prophylaxis period of 6 months or ≥ 50 EDs, whichever occurs last | Participants in the BAX 855 Safety Analysis Set who had treated bleeding episodes. | IU/kg | MEAN |
| SECONDARY | Hemostatic Efficacy Rating for Bleeding Episodes Treated With BAX 855 at Resolution of Bleed | After first exposure to BAX 855 until completion of study - approx. 6 months per participant. | Participants in the Full Analysis Set who had treated bleeding episodes. | bleeding episodes | NUMBER |
| SECONDARY | Serious Adverse Events (SAEs) Possibly or Probably Related to BAX 855 | After first exposure to BAX 855 until completion of study - approx. 6 months per participant. | BAX 855 Safety Analysis Set. | serious adverse events | NUMBER |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group194
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII) | <6 Years Old | 0 | participants | ||
| Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII) | 6 to <12 Years Old | 0 | participants | ||
| Number of Participants With Inhibitory Antibodies to Factor VIII (FVIII) | BAX 855 Safety Analysis Set | 0 | participants | ||
| Annualized Bleeding Rate (ABR) | <6 Years Old | Overall annualized bleeding rate | 2.37 | 95% Confidence Interval 3.508 | bleeding episodes per year |
| Annualized Bleeding Rate (ABR) | 6 to <12 Years Old | Overall annualized bleeding rate | 3.75 | 95% Confidence Interval 9.046 | bleeding episodes per year |
| Annualized Bleeding Rate (ABR) | Full Analysis Set | Overall annualized bleeding rate | 3.04 | 95% Confidence Interval 6.988 | bleeding episodes per year |
| Annualized Bleeding Rate (ABR) | <6 Years Old | Annualized rate of joint bleeds | 0.862 | 95% Confidence Interval 2.622 | bleeding episodes per year |
| Annualized Bleeding Rate (ABR) | 6 to <12 Years Old | Annualized rate of joint bleeds | 1.355 | 95% Confidence Interval 2.590 | bleeding episodes per year |
| Annualized Bleeding Rate (ABR) | Full Analysis Set | Annualized rate of joint bleeds | 1.103 | 95% Confidence Interval 2.597 | bleeding episodes per year |
| Annualized Bleeding Rate (ABR) | <6 Years Old | Annualized rate of target joint bleeds | 0 | 95% Confidence Interval 0.354 | bleeding episodes per year |
1 to 10 of 194Source ClinicalTrials.gov
See all 194 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | <6 Years Old | 32 | |
| Overall Study | STARTED | 6 to <12 Years Old | 34 | |
| Overall Study | COMPLETED | <6 Years Old | 32 | |
| Overall Study | COMPLETED | 6 to <12 Years Old | 32 | |
| Overall Study | NOT COMPLETED | <6 Years Old | 0 | |
| Overall Study | NOT COMPLETED | 6 to <12 Years Old | 2 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | BAX 855 Safety Analysis Set | 5 | 66 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | ADVATE Received Before BAX 855 | 0 | 31 | |
| other | Vomiting | Gastrointestinal disorders | BAX 855 Safety Analysis Set | 5 | 66 | 6 |
| other | Vomiting | Gastrointestinal disorders | ADVATE Received Before BAX 855 | 0 | 31 | |
| other | Pyrexia | General disorders | BAX 855 Safety Analysis Set | 13 | 66 | 20 |
| other | Pyrexia | General disorders | ADVATE Received Before BAX 855 | 0 | 31 | |
| other | Nasopharyngitis | Infections and infestations | BAX 855 Safety Analysis Set | 5 | 66 | 5 |
| other | Nasopharyngitis | Infections and infestations | ADVATE Received Before BAX 855 | 0 | 31 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | BAX 855 Safety Analysis Set | 9 | 66 | 9 |
| other | Upper Respiratory Tract Infection | Infections and infestations | ADVATE Received Before BAX 855 | 0 | 31 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BAX 855 Safety Analysis Set | ||
| Total, all-cause mortality | ADVATE Received Before BAX 855 | ||
| Total, other adverse events | BAX 855 Safety Analysis Set | 30 | 66 |
| Total, other adverse events | ADVATE Received Before BAX 855 | 0 | 31 |
| Total, serious adverse events | BAX 855 Safety Analysis Set | 3 | 66 |
| Total, serious adverse events | ADVATE Received Before BAX 855 | 0 | 31 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27891721 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| BAX 855 Safety Analysis Set vs ADVATE Received Before BAX 855: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02210091
GET https://conductscience.org/api/trials/v1/NCT02210091/registered?page=2