Trial · NCT01174446
Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients
NCT01174446, Phase 3, Completed, Baxalta now part of Shire; results first posted 2013-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients. Trials, record NCT01174446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01174446
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients
- NCT number
- NCT01174446
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 86 participants, actual
- Lead sponsor
- Baxalta now part of Shire
- Conditions
- Hemophilia B
- Interventions
- BAX 326, BeneFIX
- First posted
- 2010-08-03
- Last updated
- 2021-05-20
- Other registries' IDs
- eudract:2009-016720-31
- Results first posted
- 2013-11-25
Source ClinicalTrials.gov
Registered outcomes50
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Study Part 1- Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Per Dose | 72 hours | Computed using the linear trapezoidal method. The concentration at 72 hours was interpolated from the two nearest sampling time points or extrapolated using the last quantifiable concentration and the terminal rate constant λz. λz was estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R\^2. |
| Secondary | Study Parts 1 and 3: Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity Per Dose (AUC0-∞/ Dose) | 0-30 minutes before infusion up to 72 hours post-infusion | Defined as (AUC0-t + Ct)/ λz/ dose, where t is the time of last quantifiable concentration, Ct is the last quantifiable concentration. λz will be estimated from the slope of natural log-linear fitting to latter quantifiable concentrations, with largest adjusted R\^2. The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1. |
| Secondary | Study Parts 1 and 3: Mean Residence Time (MRT) | 0-30 minutes before infusion up to 72 hours post-infusion | Computed as Area under the moment curve 0-∞ (AUMC0-∞) / AUC0-∞- TI/2, where AUMC0-∞ will be determined in a similar manner as AUC0-∞ and TI represents infusion duration \[hr\] The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1. |
| Secondary | Study Parts 1 and 3: Clearance (CL) | 0-30 minutes before infusion up to 72 hours post-infusion | Computed as Dose/ AUC0-∞. The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1. |
| Secondary | Study Parts 1 and 3: Incremental Recovery at Cmax (IR at Cmax) | 0-30 minutes before infusion up to 1 hour post-infusion | Defined as (Cmax - Cpre-infusion)/Dose, where maximum concentration (Cmax) will be determined as the highest concentration achieved within one hour after infusion. The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1. |
| Secondary | Incremental Recovery (IR) at 30 Minutes Over Time | 0-30 minutes before infusion and 30 minutes post-infusion | IR at 30 Minutes was measured at the following time points during the study: - Part 1 or Part 2, Exposure Day (ED) 1. (If participant was present for Study Part 1, then ED 1 from Part 1 was used. If Participant entered study in Study Part 2, then ED 1 from Part 2 was used.) - Part 2: Week 5 - Part 2: Week 13 - Part 2 or Part 3: Week 26 (Week 26 of study participation) - Study Completion or Termination Visit |
| Secondary | Change in Incremental Recovery (IR) at 30 Minutes Over Time | 0-30 minutes before infusion and 30 minutes post-infusion | The median changes in IR at 30 Minutes, calculated as the change in IR value from exposure day 1 (ED1). |
| Secondary | Study Parts 1 and 3: Half Life (T 1/2) | 0-30 minutes before infusion up to 72 hours post-infusion | Elimination phase half-life will be determined as ln2/ λz. The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1. |
| Secondary | Study Parts 1 and 3: Volume of Distribution at Steady State (Vss) | 0-30 minutes before infusion up to 72 hours post-infusion | Vss computed as CL·MRT. The objective of Study Part 3 was to re-evaluate the Pharmacokinetic (PK) parameters for BAX 326 after a period of 6 months of treatment, in participants who accumulated at least 30 EDs to BAX 326, and to compare them with those determined in the same participants participating in Study Part 1. |
| Secondary | Study Part 2: Annualized Bleed Rate (ABR) During Treatment With BAX326 | Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks) | ABR during prophylaxis (twice-weekly) in Part 2 was calculated as (Number of bleeding episodes/observed treatment period in days) \* 365.25. The treatment period on prophylaxis was defined as time between the first and the last prophylactic infusions and ABR on prophylaxis was calculated for participants who received a minimum of 3 months of prophylactic treatment with BAX326. |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 registered outcomesOutcomes50
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Study Part 1- Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Per Dose | 72 hours | Pharmacokinetic Per Protocol Analysis Set (PKPPAS) -Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations | (IU·hr/dL) / (IU/kg) | MEDIAN |
| SECONDARY | Study Parts 1 and 3: Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity Per Dose (AUC0-∞/ Dose) | 0-30 minutes before infusion up to 72 hours post-infusion | Pharmacokinetic Per Protocol Analysis Set (PKPPAS) -Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations | (IU·hr)/ dL/ (IU/kg) | MEDIAN |
| SECONDARY | Study Parts 1 and 3: Mean Residence Time (MRT) | 0-30 minutes before infusion up to 72 hours post-infusion | Pharmacokinetic Per Protocol Analysis Set (PKPPAS) -Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations | Hour | MEDIAN |
| SECONDARY | Study Parts 1 and 3: Clearance (CL) | 0-30 minutes before infusion up to 72 hours post-infusion | Pharmacokinetic Per Protocol Analysis Set (PKPPAS) -Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations | dL/(kg·hr) | MEDIAN |
| SECONDARY | Study Parts 1 and 3: Incremental Recovery at Cmax (IR at Cmax) | 0-30 minutes before infusion up to 1 hour post-infusion | Pharmacokinetic Per Protocol Analysis Set (PKPPAS) -Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations | (IU/dL) / (IU/kg) | MEDIAN |
| SECONDARY | Incremental Recovery (IR) at 30 Minutes Over Time | 0-30 minutes before infusion and 30 minutes post-infusion | Pharmacokinetic Per Protocol Analysis Set (PKPPAS) -Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations | (IU/dL) / (IU/kg) | MEDIAN |
| SECONDARY | Change in Incremental Recovery (IR) at 30 Minutes Over Time | 0-30 minutes before infusion and 30 minutes post-infusion | Pharmacokinetic Per Protocol Analysis Set (PKPPAS) -Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations | (IU/dL) / (IU/kg) | MEDIAN |
| SECONDARY | Study Parts 1 and 3: Half Life (T 1/2) | 0-30 minutes before infusion up to 72 hours post-infusion | Pharmacokinetic Per Protocol Analysis Set (PKPPAS) -Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations | Hour | MEDIAN |
| SECONDARY | Study Parts 1 and 3: Volume of Distribution at Steady State (Vss) | 0-30 minutes before infusion up to 72 hours post-infusion | Pharmacokinetic Per Protocol Analysis Set (PKPPAS) -Participants who participated in Study Parts 1-3 and completed Study Part 1 without any major protocol deviations | dL/kg | MEDIAN |
| SECONDARY | Study Part 2: Annualized Bleed Rate (ABR) During Treatment With BAX326 | Study Part 2 = 26 weeks ± 1 week (Note: Study Part 1 = 2-4 weeks) | Full Analysis Set - Prophylactic cohort | Bleeds per year | MEDIAN |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 outcomesResults by group322
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Study Part 1- Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Per Dose | BAX326 | 14.30 | Inter-Quartile Range 11.20 to 15.95 | (IU·hr/dL) / (IU/kg) | |
| Study Part 1- Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours Per Dose | BeneFIX | 13.42 | Inter-Quartile Range 11.08 to 15.10 | (IU·hr/dL) / (IU/kg) | |
| Study Parts 1 and 3: Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity Per Dose (AUC0-∞/ Dose) | Study Part 1: BAX326 | 16.07 | Inter-Quartile Range 13.43 to 17.48 | (IU·hr)/ dL/ (IU/kg) | |
| Study Parts 1 and 3: Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity Per Dose (AUC0-∞/ Dose) | Study Part 1: BeneFIX | 15.26 | Inter-Quartile Range 13.71 to 17.05 | (IU·hr)/ dL/ (IU/kg) | |
| Study Parts 1 and 3: Area Under the Plasma Concentration/Time Curve From Time 0 to Infinity Per Dose (AUC0-∞/ Dose) | Study Part 3: BAX326 | 17.38 | Inter-Quartile Range 14.17 to 20.70 | (IU·hr)/ dL/ (IU/kg) | |
| Study Parts 1 and 3: Mean Residence Time (MRT) | Study Part 1: BAX326 | 28.93 | Inter-Quartile Range 26.45 to 31.50 | Hour | |
| Study Parts 1 and 3: Mean Residence Time (MRT) | Study Part 1: BeneFIX | 30.59 | Inter-Quartile Range 28.13 to 34.84 | Hour | |
| Study Parts 1 and 3: Mean Residence Time (MRT) | Study Part 3: BAX326 | 29.04 | Inter-Quartile Range 28.00 to 32.31 | Hour | |
| Study Parts 1 and 3: Clearance (CL) | Study Part 1: BAX326 | 0.0622 | Inter-Quartile Range 0.0572 to 0.0745 | dL/(kg·hr) | |
| Study Parts 1 and 3: Clearance (CL) | Study Part 1: BeneFIX | 0.0655 | Inter-Quartile Range 0.0587 to 0.0730 | dL/(kg·hr) |
1 to 10 of 322Source ClinicalTrials.gov
See all 322 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 -Pharmacokinetic Crossover | STARTED | PK (BAX326 Then BeneFIX) Then Prophylaxis Then PK BAX326 Only | 14 | |
| Part 1 -Pharmacokinetic Crossover | STARTED | PK (BeneFIX Then BAX326) Then Prophylaxis Then PK BAX326 Only | 14 | |
| Part 1 -Pharmacokinetic Crossover | STARTED | Study Part 2 Only: BAX326 Prophylaxis | 0 | |
| Part 1 -Pharmacokinetic Crossover | STARTED | Study Part 2 Only: BAX326 On-Demand | 0 | |
| Part 1 -Pharmacokinetic Crossover | COMPLETED | PK (BAX326 Then BeneFIX) Then Prophylaxis Then PK BAX326 Only | 14 | |
| Part 1 -Pharmacokinetic Crossover | COMPLETED | PK (BeneFIX Then BAX326) Then Prophylaxis Then PK BAX326 Only | 14 | |
| Part 1 -Pharmacokinetic Crossover | COMPLETED | Study Part 2 Only: BAX326 Prophylaxis | 0 | |
| Part 1 -Pharmacokinetic Crossover | COMPLETED | Study Part 2 Only: BAX326 On-Demand | 0 | |
| Part 1 -Pharmacokinetic Crossover | NOT COMPLETED | PK (BAX326 Then BeneFIX) Then Prophylaxis Then PK BAX326 Only | 0 | |
| Part 1 -Pharmacokinetic Crossover | NOT COMPLETED | PK (BeneFIX Then BAX326) Then Prophylaxis Then PK BAX326 Only | 0 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events7
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 | Nasopharyngitis | Infections and infestations | BAX326 | 6 | 73 | 8 |
| other | Immunology Test Abnormal | Investigations | BAX326 | 12 | 73 | 12 |
| serious | Intestinal Obstruction | Gastrointestinal disorders | BAX326 | 1 | 73 | 1 |
| serious | Cervical Vertebral Fracture | Injury, poisoning and procedural complications | BAX326 | 1 | 73 | 1 |
| serious | Traumatic Haematoma | Injury, poisoning and procedural complications | BAX326 | 1 | 73 | 1 |
| serious | Hepatitis B Core Antibody Positive | Investigations | BAX326 | 1 | 73 | 1 |
| serious | Convulsion | Nervous system disorders | BAX326 | 1 | 73 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BAX326 | ||
| Total, other adverse events | BAX326 | 15 | 73 |
| Total, serious adverse events | BAX326 | 4 | 73 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23834666 | 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 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/NCT01174446
GET https://conductscience.org/api/trials/v1/NCT01174446/registered?page=2