Trial · NCT00866606
Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
NCT00866606, Phase 3, Completed, Wyeth is now a wholly owned subsidiary of Pfizer; results first posted 2011-01-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects. Trials, record NCT00866606. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00866606
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
- NCT number
- NCT00866606
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 35 participants, actual
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Conditions
- Hemophilia B
- Interventions
- Benefix
- First posted
- 2009-03-20
- Last updated
- 2011-04-05
- Results first posted
- 2011-01-04
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion | 8 hours post infusion | Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens. |
| Primary | Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion | 24 hours post infusion | Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens. |
| Primary | Percentage of Participants With FIX Inhibitor Development | Baseline up to 6 months | Incidence of FIX inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory with Nijmegen assay result \>=0.6 Bethesda Unit (BU). Incidence was stratified by participant exposure history - Minimally Treated Patients (MTPs): those who had received at least one prior FIX infusion, and \<= 100 documented Exposure Days (EDs); while Previously Treated Patients (PTPs): those who had received \>100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population. |
| Secondary | Number of Infusions Required to Treat Each Bleed | Baseline up to 6 months | The number of BeneFIX infusions required to treat each bleeding episode were analyzed. The average frequency of BeneFIX infusions per hemorrhage incidence to treat every hemorrhage was equal to the total number of injections throughout the study divided by total number of hemorrhagic events. |
| Secondary | FIX Incremental Recovery | Baseline (Visit 2) up to 6 months (Visit 4) | FIX recovery was assessed by evaluating FIX:C after initial exposure and following 6 months of repeated exposures to BeneFIX. A modified FIX recovery study was performed at Day 1 (Visit 2) and Month 6/Final/Early Termination visits (Visit 4) and when clinically indicated at the applicable on-demand visits. Blood samples for determination of FIX:C were collected immediately before BeneFIX infusion and at 30 minutes (±5 minutes) after the start of infusion. Post-infusion blood samples were collected via venipuncture in arm contralateral to arm used for infusion. |
| Secondary | Percentage of Participants With Less Than Expected Therapeutic Effect (LETE) | Baseline up to 6 months | The incidence of LETE for on-demand treatment was defined as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors. |
| Secondary | Percentage of Participants With Allergic-Type Allergic Reactions | Baseline up to 6 months | Hypersensitivity to undesirable (damaging, discomfort-producing and sometimes fatal) reactions produced by the normal immune system. Hypersensitivity reactions require a pre-sensitized (immune) state of the host. |
| Secondary | Percentage of Participants With Thrombosis | Baseline up to 6 months | Thrombosis is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. When a blood vessel is injured, the body uses platelets and fibrin to form a blood clot to prevent blood loss. |
| Secondary | Percentage of Participants With Red Blood Cell (RBC) Agglutination | Baseline up to 6 months | RBC Agglutination is the clumping of red blood cells in the presence of an antibody. The antibody or other molecule bonded multiple particles and joined them, creating a large complex. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion | 8 hours post infusion | FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. | Units on a scale | MEAN |
| PRIMARY | Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion | 24 hours post infusion | FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. | Units on a scale | MEAN |
| PRIMARY | Percentage of Participants With FIX Inhibitor Development | Baseline up to 6 months | Safety Set (SS) population included all enrolled participants who had taken at least 1 dose of drug.The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each visit respectively. | Percentage of Participants | NUMBER |
| SECONDARY | Number of Infusions Required to Treat Each Bleed | Baseline up to 6 months | FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. | Infusions | MEAN |
| SECONDARY | FIX Incremental Recovery | Baseline (Visit 2) up to 6 months (Visit 4) | FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each visit respectively. | IU/dL per IU/kg | MEAN |
| SECONDARY | Percentage of Participants With Less Than Expected Therapeutic Effect (LETE) | Baseline up to 6 months | FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Allergic-Type Allergic Reactions | Baseline up to 6 months | SS population included all enrolled participants who had taken at least 1 dose of drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Thrombosis | Baseline up to 6 months | SS population included all enrolled participants who had taken at least 1 dose of drug. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Red Blood Cell (RBC) Agglutination | Baseline up to 6 months | SS population included all enrolled participants who had taken at least 1 dose of drug. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion | BeneFactor IX (BeneFIX) | 1.70 | Standard Deviation 0.72 | Units on a scale | |
| Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion | BeneFactor IX (BeneFIX) | 1.58 | Standard Deviation 0.71 | Units on a scale | |
| Percentage of Participants With FIX Inhibitor Development | BeneFactor IX (BeneFIX) | Total (n=35) | 2.86 | Percentage of Participants | |
| Percentage of Participants With FIX Inhibitor Development | BeneFactor IX (BeneFIX) | MTP (n=24) | 4.17 | Percentage of Participants | |
| Percentage of Participants With FIX Inhibitor Development | BeneFactor IX (BeneFIX) | PTP (n=11) | 0 | Percentage of Participants | |
| Number of Infusions Required to Treat Each Bleed | BeneFactor IX (BeneFIX) | 1.20 | Standard Deviation 0.86 | Infusions | |
| FIX Incremental Recovery | BeneFactor IX (BeneFIX) | Visit 2 (n=30) | 0.760 | Standard Deviation 0.222 | IU/dL per IU/kg |
| FIX Incremental Recovery | BeneFactor IX (BeneFIX) | Visit 4 (n=31) | 0.727 | Standard Deviation 0.275 | IU/dL per IU/kg |
| Percentage of Participants With Less Than Expected Therapeutic Effect (LETE) | BeneFactor IX (BeneFIX) | 0 | Percentage of Participants | ||
| Percentage of Participants With Allergic-Type Allergic Reactions | BeneFactor IX (BeneFIX) | 0 | Percentage of Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BeneFactor IX (BeneFIX) | 35 | |
| Overall Study | COMPLETED | BeneFactor IX (BeneFIX) | 31 | |
| Overall Study | NOT COMPLETED | BeneFactor IX (BeneFIX) | 4 |
Source ClinicalTrials.gov
Adverse events17
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 | Anemia | Blood and lymphatic system disorders | BeneFactor IX (BeneFIX) | 2 | 35 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | BeneFactor IX (BeneFIX) | 1 | 35 | 1 |
| other | Fatigue | General disorders | BeneFactor IX (BeneFIX) | 1 | 35 | 1 |
| other | Inflammation | General disorders | BeneFactor IX (BeneFIX) | 2 | 35 | 2 |
| other | Edema peripheral | General disorders | BeneFactor IX (BeneFIX) | 1 | 35 | 1 |
| other | Fall | Injury, poisoning and procedural complications | BeneFactor IX (BeneFIX) | 1 | 35 | 1 |
| other | Injury | Injury, poisoning and procedural complications | BeneFactor IX (BeneFIX) | 2 | 35 | 2 |
| other | Joint Sprain | Injury, poisoning and procedural complications | BeneFactor IX (BeneFIX) | 2 | 35 | 2 |
| other | Alanine aminotransferase increased | Investigations | BeneFactor IX (BeneFIX) | 1 | 35 | 1 |
| other | Hematocrit abnormal | Investigations | BeneFactor IX (BeneFIX) | 1 | 35 | 1 |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BeneFactor IX (BeneFIX) | ||
| Total, other adverse events | BeneFactor IX (BeneFIX) | 19 | 35 |
| Total, serious adverse events | BeneFactor IX (BeneFIX) | 2 | 35 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22776196 | DERIVED |
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/NCT00866606
GET https://conductscience.org/api/trials/v1/NCT00866606/registered