Trial · NCT00768287
Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B
NCT00768287, Phase 2, Phase 3, Completed, Medexus Pharma, Inc.; results first posted 2018-09-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B. Trials, record NCT00768287. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00768287
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Recombinant Factor IX Product, IB1001, in Subjects With Hemophilia B
- NCT number
- NCT00768287
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 77 participants, actual
- Lead sponsor
- Medexus Pharma, Inc.
- Conditions
- Hemophilia B
- Interventions
- IB1001, nonacog alfa
- First posted
- 2008-10-08
- Last updated
- 2021-04-06
- Results first posted
- 2018-09-10
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Degree of Hemorrhage Control by Treatment Regimen | Prophylaxis Group Duration of Treatment: 17.9 ± 9.6 months; On Demand Group Duration of Treatment: 15.9 ± 11.5 months | Subject rating of bleed control within 6 hours of the time bleeding has stopped: 1. Excellent: a dramatic response with abrupt pain relief and clear reduction in joint or hemorrhage site size; 2. Good: pain relief or reduction in hemorrhage site size that may have required an additional infusion for resolution; 3. Fair: probable or slight beneficial response usually requiring one or more additional infusions for resolution; 4. Poor: no improvement or condition worsens. |
| Secondary | Area Under the Curve (0-inf) | Pre-infusion to 72 hours following infusion | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. |
| Secondary | Area Under the Curve (0-72 hr) | Pre-infusion to 72 hours following infusion | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. |
| Secondary | Terminal Half-life | Pre-infusion to 72 hours following infusion | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. |
| Secondary | Concentration (Max) | Pre-infusion to 72 hours following infusion | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. |
| Secondary | Incremental Recovery | Pre-infusion to 72 hours following infusion | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. |
| Secondary | Mean Residence Time | Pre-infusion to 72 hours following infusion | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. |
| Secondary | Clearance | Pre-infusion to 72 hours following infusion | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. |
| Secondary | Volume of Distribution (Steady State) | Pre-infusion to 72 hours following infusion | Factor IX levels were assessed at the following time points: Pre-infusion, post-infusion at 30 min ± 5 min, 1 hour ± 5 min, 3 hours ± 30 min, 6 hours ± 1 hour, 9 hours ± 1 hour, 12 hours ± 2 hours, 24 hours ± 3 hours, 36 hours ± 3 hours, 48 hours ± 3 hours, 60 hours ± 3 hours, and 72 hours ± 3 hours. |
| Secondary | Annualized Bleed Rate | Prophylaxis Group Duration of Treatment: 17.9 ± 9.6 months; On Demand Group Duration of Treatment: 15.9 ± 11.5 months | Measure was assessed during the Treatment Study |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Degree of Hemorrhage Control by Treatment Regimen | Prophylaxis Group Duration of Treatment: 17.9 ± 9.6 months; On Demand Group Duration of Treatment: 15.9 ± 11.5 months | The 68 patients in the Treatment Study (Part 2) were assigned to an initial treatment regimen as follows: prophylaxis (n=58), on demand (n=9), and unassigned (n=1). Patients were allowed to switch regimens during the course of the study. As a result 61 patients were treated with prophylaxis and 12 patients were treated on demand. | Bleeding Episodes | COUNT_OF_UNITS |
| SECONDARY | Area Under the Curve (0-inf) | Pre-infusion to 72 hours following infusion | IU*hr/dL | MEAN | |
| SECONDARY | Area Under the Curve (0-72 hr) | Pre-infusion to 72 hours following infusion | IU*hr/dL | MEAN | |
| SECONDARY | Terminal Half-life | Pre-infusion to 72 hours following infusion | hours | MEAN | |
| SECONDARY | Concentration (Max) | Pre-infusion to 72 hours following infusion | IU/dL | MEAN | |
| SECONDARY | Incremental Recovery | Pre-infusion to 72 hours following infusion | IU/dL per IU/kg | MEAN | |
| SECONDARY | Mean Residence Time | Pre-infusion to 72 hours following infusion | hours | MEAN | |
| SECONDARY | Clearance | Pre-infusion to 72 hours following infusion | dL/kg*hr | MEAN | |
| SECONDARY | Volume of Distribution (Steady State) | Pre-infusion to 72 hours following infusion | dL/kg | MEAN | |
| SECONDARY | Annualized Bleed Rate | Prophylaxis Group Duration of Treatment: 17.9 ± 9.6 months; On Demand Group Duration of Treatment: 15.9 ± 11.5 months | The 68 patients in the Treatment Study (Part 2) were assigned to an initial treatment regimen as follows: prophylaxis (n=58), on demand (n=9), and unassigned (n=1). Patients were allowed to switch regimens during the course of the study. As a result 61 patients were treated with prophylaxis and 12 patients were treated on demand. | Bleeds/year | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group47
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Degree of Hemorrhage Control by Treatment Regimen | IB1001 (On Demand) | Excellent | 53 | Bleeding Episodes | |
| Degree of Hemorrhage Control by Treatment Regimen | IB1001 (Prophylaxis) | Excellent | 116 | Bleeding Episodes | |
| Degree of Hemorrhage Control by Treatment Regimen | IB1001 (On Demand) | Good | 105 | Bleeding Episodes | |
| Degree of Hemorrhage Control by Treatment Regimen | IB1001 (Prophylaxis) | Good | 74 | Bleeding Episodes | |
| Degree of Hemorrhage Control by Treatment Regimen | IB1001 (On Demand) | Fair | 25 | Bleeding Episodes | |
| Degree of Hemorrhage Control by Treatment Regimen | IB1001 (Prophylaxis) | Fair | 28 | Bleeding Episodes | |
| Degree of Hemorrhage Control by Treatment Regimen | IB1001 (On Demand) | Poor | 3 | Bleeding Episodes | |
| Degree of Hemorrhage Control by Treatment Regimen | IB1001 (Prophylaxis) | Poor | 9 | Bleeding Episodes | |
| Degree of Hemorrhage Control by Treatment Regimen | IB1001 (On Demand) | Not Rated | 36 | Bleeding Episodes | |
| Degree of Hemorrhage Control by Treatment Regimen | IB1001 (Prophylaxis) | Not Rated | 59 | Bleeding Episodes |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow78
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pharmacokinetic Study | STARTED | PK: IB1001 First, Then Nonacog Alfa | 16 | |
| Pharmacokinetic Study | STARTED | PK: Nonacog Alfa First, Then IB1001 | 16 | |
| Pharmacokinetic Study | STARTED | Repeat IB1001 PK | 0 | |
| Pharmacokinetic Study | STARTED | IB1001 Prophylaxis | 0 | |
| Pharmacokinetic Study | STARTED | IB1001 On Demand | 0 | |
| Pharmacokinetic Study | STARTED | IB1001 Surgical Substudy | 0 | |
| Pharmacokinetic Study | COMPLETED | PK: IB1001 First, Then Nonacog Alfa | 16 | |
| Pharmacokinetic Study | COMPLETED | PK: Nonacog Alfa First, Then IB1001 | 16 | |
| Pharmacokinetic Study | COMPLETED | Repeat IB1001 PK | 0 | |
| Pharmacokinetic Study | COMPLETED | IB1001 Prophylaxis | 0 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 participant flowAdverse events34
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 | Constipation | Gastrointestinal disorders | IB1001 Safety Population | 4 | 77 | 8 |
| other | Dairrhoea | Gastrointestinal disorders | IB1001 Safety Population | 7 | 77 | 7 |
| other | Nausea | Gastrointestinal disorders | IB1001 Safety Population | 4 | 77 | 6 |
| other | Vomiting | Gastrointestinal disorders | IB1001 Safety Population | 6 | 77 | 7 |
| other | Pyrexia | General disorders | IB1001 Safety Population | 10 | 77 | 10 |
| other | Nasopharyngitis | Infections and infestations | IB1001 Safety Population | 9 | 77 | 18 |
| other | Contusion | Injury, poisoning and procedural complications | IB1001 Safety Population | 4 | 77 | 7 |
| other | Limb injury | Injury, poisoning and procedural complications | IB1001 Safety Population | 8 | 77 | 8 |
| other | Procedural pain | Injury, poisoning and procedural complications | IB1001 Safety Population | 4 | 77 | 6 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | IB1001 Safety Population | 12 | 77 | 22 |
1 to 10 of 34Source ClinicalTrials.gov
See all 34 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | IB1001 Safety Population | ||
| Total, other adverse events | IB1001 Safety Population | 58 | 77 |
| Total, serious adverse events | IB1001 Safety Population | 10 | 77 |
Source ClinicalTrials.gov
Papers2
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.
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