Trial · NCT02585960
BAX 855 PK-guided Dosing
NCT02585960, Phase 3, Completed, Baxalta now part of Shire; results first posted 2019-08-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BAX 855 PK-guided Dosing. Trials, record NCT02585960. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02585960
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BAX 855 PK-guided Dosing
- NCT number
- NCT02585960
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 135 participants, actual
- Lead sponsor
- Baxalta now part of Shire
- Conditions
- Hemophilia A
- Interventions
- PEGylated Recombinant Factor VIII, PEGylated Recombinant Factor VIII, PEGylated Recombinant Factor VIII
- First posted
- 2015-10-26
- Last updated
- 2021-05-25
- Other registries' IDs
- eudract:2014-005477-37
- Results first posted
- 2019-08-26
Source ClinicalTrials.gov
Registered outcomes26
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Total Annualized Bleeding Rate (ABR) of Zero for Second Six Months | Day 183 to Day 364 (6 months) | Annualized bleeding rate was determined by dividing the number of bleeds by observation period in years. |
| Secondary | Total Annualized Bleeding Rate for Second Six Months | Day 183 to Day 364 (6 months) | Annualized bleeding rate was determined by dividing the number of bleeds by observation period in years. |
| Secondary | Annualized Spontaneous Bleeding Rate for Second Six Months | Day 183 to Day 364 (6 months) | Annualized spontaneous bleeding rate was determined by dividing the number of spontaneous bleeds by observation period in years. A bleed was defined as spontaneous if it was not related to injury/trauma. |
| Secondary | Annualized Traumatic Bleeding Rate for Second Six Months | Day 183 to Day 364 (6 months) | Annualized traumatic bleeding rate was determined by dividing the number of traumatic bleeds by observation period in years. A bleed was defined as traumatic if it was related to injury/trauma. |
| Secondary | Annualized Joint Bleeding Rate (AJBR) for Second Six Months | Day 183 to Day 364 (6 months) | Annualized joint bleeding rate was determined by dividing the number of joint bleeds by observation period in years. An acute joint bleed include some or all of the following: 'aura', pain, swelling, warmth of the skin over the joint, decreased range of motion and difficulty in using the limb compared with baseline or loss of function. |
| Secondary | Total Weight-adjusted Consumption of BAX 855 | From start of study treatment up to 12 months (completion or termination) | Total weight-adjusted consumption of BAX 855 were reported. |
| Secondary | Number of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Number of Infusions | 8 hours after study drug administration | The participant or caregiver rated the overall treatment response using a 4-point efficacy rating scale as Excellent: Full relief of pain and cessation of objective signs of bleeding after a single infusion and no additional infusion is required for the control of bleeding; Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion and 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 a single infusion and required more than 1 infusion for complete resolution and None: No improvement or condition worsens. |
| Secondary | Number of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Bleed Resolution | From start of study treatment up to bleed resolution (up to 12 months) | The participant or caregiver rated the overall treatment response using a 4-point efficacy rating scale as Excellent: Full relief of pain and cessation of objective signs of bleeding after a single infusion and no additional infusion is required for the control of bleeding; Good: Definite pain relief and/or improvement in signs of bleeding after a single infusion and 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 a single infusion and required more than 1 infusion for complete resolution and None: No improvement or condition worsens. |
| Secondary | Treatment of Bleeding Episodes: Number of BAX 855 Infusions Per Bleeding Episode Required Until Bleed Resolution | From start of study treatment up to 12 months (completion or termination) | Infusions of BAX 855 that were required until bleed resolution were reported. |
| Secondary | Change From Baseline in Hemophilia Joint Health Score (HJHS)- Total Score | Baseline, Month 12 | HJHS was assessed based on the following components of the elbow, knee, and ankle joints: swelling, duration of swelling, muscle atrophy, crepitus on motion, flexion loss, extension loss, joint pain, and strength, together with an assessment of the global gait. The HJHS is a validated 11-item scoring tool based on radiologic and clinical evaluation, sensitive to detect early signs and minor changes. HJHS ranges from 0 to 124. Higher values in the HJHS represent worse situation for the participant. |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 registered outcomesOutcomes26
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Total Annualized Bleeding Rate (ABR) of Zero for Second Six Months | Day 183 to Day 364 (6 months) | Full analysis set (FAS) included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. | Percentage of participants | NUMBER |
| SECONDARY | Total Annualized Bleeding Rate for Second Six Months | Day 183 to Day 364 (6 months) | FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time point. | Bleeds per year | MEAN |
| SECONDARY | Annualized Spontaneous Bleeding Rate for Second Six Months | Day 183 to Day 364 (6 months) | FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time point. | Bleeds per year | MEAN |
| SECONDARY | Annualized Traumatic Bleeding Rate for Second Six Months | Day 183 to Day 364 (6 months) | FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points. | Bleeds per year | MEAN |
| SECONDARY | Annualized Joint Bleeding Rate (AJBR) for Second Six Months | Day 183 to Day 364 (6 months) | FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points. | Bleeds per year | MEAN |
| SECONDARY | Total Weight-adjusted Consumption of BAX 855 | From start of study treatment up to 12 months (completion or termination) | FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. | International units per kilogram (IU/kg) | MEAN |
| SECONDARY | Number of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Number of Infusions | 8 hours after study drug administration | FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points. | Treated Bleeds | NUMBER |
| SECONDARY | Number of Bleeding Episodes: Overall Hemostatic Efficacy Rating at Bleed Resolution | From start of study treatment up to bleed resolution (up to 12 months) | FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points. | Treated Bleeds | NUMBER |
| SECONDARY | Treatment of Bleeding Episodes: Number of BAX 855 Infusions Per Bleeding Episode Required Until Bleed Resolution | From start of study treatment up to 12 months (completion or termination) | FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants with treated bleeds. | Infusions | MEAN |
| SECONDARY | Change From Baseline in Hemophilia Joint Health Score (HJHS)- Total Score | Baseline, Month 12 | FAS included all participants who were randomized to one of the two prophylactic arms and treated prophylactically for any period of time. Here Number of participants analyzed refer to number of participants evaluable for this outcome at specified time points. | Score on a scale | MEAN |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 outcomesResults by group181
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Total Annualized Bleeding Rate (ABR) of Zero for Second Six Months | BAX 855-Low Level | 42.1 | Percentage of participants | ||
| Percentage of Participants With a Total Annualized Bleeding Rate (ABR) of Zero for Second Six Months | BAX 855-High Level | 62.1 | Percentage of participants | ||
| Total Annualized Bleeding Rate for Second Six Months | BAX 855-Low Level | 3.603 | Standard Deviation 7.512 | Bleeds per year | |
| Total Annualized Bleeding Rate for Second Six Months | BAX 855-High Level | 1.649 | Standard Deviation 3.433 | Bleeds per year | |
| Annualized Spontaneous Bleeding Rate for Second Six Months | BAX 855 - Low Level | 2.489 | Standard Deviation 6.554 | Bleeds per year | |
| Annualized Spontaneous Bleeding Rate for Second Six Months | BAX 855 - High Level | 0.737 | Standard Deviation 1.738 | Bleeds per year | |
| Annualized Traumatic Bleeding Rate for Second Six Months | BAX 855-Low Level | 1.114 | Standard Deviation 2.037 | Bleeds per year | |
| Annualized Traumatic Bleeding Rate for Second Six Months | BAX 855-High Level | 0.912 | Standard Deviation 2.647 | Bleeds per year | |
| Annualized Joint Bleeding Rate (AJBR) for Second Six Months | BAX 855-Low Level | 2.617 | Standard Deviation 7.361 | Bleeds per year | |
| Annualized Joint Bleeding Rate (AJBR) for Second Six Months | BAX 855-High Level | 1.079 | Standard Deviation 2.553 | Bleeds per year |
1 to 10 of 181Source ClinicalTrials.gov
See all 181 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| PK/Safety Assessment Period | STARTED | BAX 855-Low Level | 57 | |
| PK/Safety Assessment Period | STARTED | BAX 855-High Level | 58 | |
| PK/Safety Assessment Period | STARTED | BAX 855-Non-randomized | 6 | |
| PK/Safety Assessment Period | Completed 1st 6 Month Period | BAX 855-Low Level | 57 | |
| PK/Safety Assessment Period | Completed 1st 6 Month Period | BAX 855-High Level | 53 | |
| PK/Safety Assessment Period | Completed 1st 6 Month Period | BAX 855-Non-randomized | 0 | |
| PK/Safety Assessment Period | Completed 2nd 6 Month Period | BAX 855-Low Level | 52 | |
| PK/Safety Assessment Period | Completed 2nd 6 Month Period | BAX 855-High Level | 48 | |
| PK/Safety Assessment Period | Completed 2nd 6 Month Period | BAX 855-Non-randomized | 0 | |
| PK/Safety Assessment Period | COMPLETED | BAX 855-Low Level | 52 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events60
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 | Arthralgia | Musculoskeletal and connective tissue disorders | BAX 855-Low Level | 6 | 57 | 7 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | BAX 855-High Level | 5 | 58 | 5 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | BAX 855-Non-randomized | 0 | 6 | 0 |
| other | Back pain | Musculoskeletal and connective tissue disorders | BAX 855-Low Level | 1 | 57 | 2 |
| other | Back pain | Musculoskeletal and connective tissue disorders | BAX 855-High Level | 3 | 58 | 3 |
| other | Back pain | Musculoskeletal and connective tissue disorders | BAX 855-Non-randomized | 0 | 6 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | BAX 855-Low Level | 3 | 57 | 3 |
| other | Diarrhoea | Gastrointestinal disorders | BAX 855-High Level | 2 | 58 | 2 |
| other | Diarrhoea | Gastrointestinal disorders | BAX 855-Non-randomized | 0 | 6 | 0 |
| other | Pyrexia | General disorders | BAX 855-Low Level | 2 | 57 | 2 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BAX 855-Low Level | 0 | 57 |
| Total, all-cause mortality | BAX 855-High Level | 0 | 58 |
| Total, all-cause mortality | BAX 855-Non-randomized | 0 | 6 |
| Total, other adverse events | BAX 855-Low Level | 25 | 57 |
| Total, other adverse events | BAX 855-High Level | 25 | 58 |
| Total, other adverse events | BAX 855-Non-randomized | 0 | 6 |
| Total, serious adverse events | BAX 855-Low Level | 5 | 57 |
| Total, serious adverse events | BAX 855-High Level | 5 | 58 |
| Total, serious adverse events | BAX 855-Non-randomized | 0 | 6 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02585960
GET https://conductscience.org/api/trials/v1/NCT02585960/registered?page=2