Trial · NCT00484185
Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
NCT00484185, Completed, Pfizer; results first posted 2013-08-12
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B. Trials, record NCT00484185. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00484185
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B
- NCT number
- NCT00484185
- Status
- Completed
- Enrollment
- 183 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Hemophilia B
- Interventions
- BeneFIX (coagulation factor IX (recombinant))
- First posted
- 2007-06-08
- Last updated
- 2013-08-12
- Results first posted
- 2013-08-12
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) According to Baseline Characteristics | Baseline up to 6 months | AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. AE assessed by baseline characteristics (chr) included age, gender, pediatric/geriatric status, liver disorder, BeneFIX treatment (previously/newly), factor nine (FIX) gene mutation, prior exposure to plasma-derived FIX products, prior FIX regimen(s) utilized, personal history of FIX inhibitor, family history of hemophilia B, severity of bleeding, medical history, concomitant medication and therapy. |
| Primary | Number of Participants With Adverse Events (AEs) According to Severity | Baseline up to 6 months | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AE was assessed according to severity; mild (not causing any significant problem, dose adjustment not required), moderate (caused problem that does not interfere significantly with usual activities or the clinical status, dose adjustment needed due to adverse event) and severe (caused problem that interferes significantly with usual activities or the clinical status, study drug stopped due to adverse event). |
| Primary | Number of Participants With Action Taken in Response to Adverse Events (AEs) | Baseline up to 6 months | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. After an onset of an AE, relevant actions were undertaken on the study drug or the participant. Actions related to study drug included: dosage reduced, dosage increased, stopped temporarily or permanently, no action taken; actions related to participants included: withdrawal from the study, concomitant medication, no action taken or any other as per physician's discretion. |
| Primary | Number of Participants With Adverse Events (AEs) According to Seriousness | Baseline up to 6 months | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Seriousness of an AE was assessed under the criteria of serious adverse event (SAE). An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
| Primary | Number of Participants With Outcome in Response to Adverse Events (AEs) | Baseline up to 6 months | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Outcome of an AE was assessed based on response to a question 'Is the adverse event still present?' as 'yes', 'unknown' or 'no-resolved'. |
| Primary | Number of Participants With Adverse Events (AEs) by Relationship | Baseline up to 6 months | AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. All causalities and drug-related AEs reported. Drug-related AEs based on physician's discretion: certain (AE after drug intake, not explained by other drugs, reaction on drug cessation \[DC\], relapse on re-intake of drug), probable/likely (AE after drug intake, not explained by other drugs, reaction on DC, no information on re-intake), possible (AE after drug intake, explained by other drugs, no information on DC), unlikely (not related to drug intake time, explained by other drugs). |
| Primary | Number of Participants With Unexpected Adverse Events (AEs) | Baseline up to 6 months | AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Unexpected AEs were those that were not included in precaution of local product document. |
| Secondary | Mean Annualized Bleeding Rate (ABR) | Baseline up to 6 months | An annualized bleeding rate (ABR) was calculated as the number of bleeds requiring administration of BeneFIX (for on-demand therapy and surgery), divided by total period of bleeding multiplied by 365.25. Total period of bleeding is the number of days on treatment for prophylaxis purpose and on-demand therapy and surgery. |
| Secondary | Number of Responses to On-demand Treatment With Study Medication | Baseline up to 6 months | Responses to on-demand treatment were rated by participant/caregiver or physician each time the drug was administered, on 4-point scale. Score 1=excellent (definite pain relief \[PR\] and improvement \[imp\] within 8 hours \[h\] of infusion \[inf\], no additional inf); score 2=good (definite PR and imp within 8h of inf, at least 1 additional inf for complete resolution \[CR\] of bleeding or starting after 8h of inf, no additional inf); score 3=moderate (probable or slight imp starting after 8h of inf, at least 1 additional inf for CR of bleeding); score 4=no imp at all, or condition worsens). |
| Secondary | Mean Number of Infusion of Study Medication | Baseline up to 6 months | Mean frequency of BeneFIX administration of each participant was calculated from number of BeneFIX infusions which each participant received for treatment of each new bleed. Mean frequency of BeneFIX administration for total participants was summarized. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
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 Adverse Events (AEs) According to Baseline Characteristics | Baseline up to 6 months | Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs. | participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events (AEs) According to Severity | Baseline up to 6 months | Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs. Same participant may be represented in more than 1 category. | participants | NUMBER |
| PRIMARY | Number of Participants With Action Taken in Response to Adverse Events (AEs) | Baseline up to 6 months | Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis. | ||
| PRIMARY | Number of Participants With Adverse Events (AEs) According to Seriousness | Baseline up to 6 months | Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs. | participants | NUMBER |
| PRIMARY | Number of Participants With Outcome in Response to Adverse Events (AEs) | Baseline up to 6 months | Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis. | ||
| PRIMARY | Number of Participants With Adverse Events (AEs) by Relationship | Baseline up to 6 months | Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs. | participants | NUMBER |
| PRIMARY | Number of Participants With Unexpected Adverse Events (AEs) | Baseline up to 6 months | Safety analysis set included all participants who received at least 1 dose of study medication including dropouts due to AEs. | participants | NUMBER |
| SECONDARY | Mean Annualized Bleeding Rate (ABR) | Baseline up to 6 months | Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | bleeds per year | MEAN |
| SECONDARY | Number of Responses to On-demand Treatment With Study Medication | Baseline up to 6 months | Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | responses | NUMBER |
| SECONDARY | Mean Number of Infusion of Study Medication | Baseline up to 6 months | Efficacy analysis set included all participants who received at least 1 dose of study medication for the approved indications and were evaluated upon its related parameters at least once. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this measure. | infusions | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group63
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 Adverse Events (AEs) According to Baseline Characteristics | BeneFIX | Age: Less than (<) 10 years | 0 | participants | |
| Number of Participants With Adverse Events (AEs) According to Baseline Characteristics | BeneFIX | Age: 10 to 19 years | 1 | participants | |
| Number of Participants With Adverse Events (AEs) According to Baseline Characteristics | BeneFIX | Age: 20 to 29 years | 2 | participants | |
| Number of Participants With Adverse Events (AEs) According to Baseline Characteristics | BeneFIX | Age: 30 to 39 years | 3 | participants | |
| Number of Participants With Adverse Events (AEs) According to Baseline Characteristics | BeneFIX | Age: 40 to 49 years | 1 | participants | |
| Number of Participants With Adverse Events (AEs) According to Baseline Characteristics | BeneFIX | Age: Greater than or equal (>=) to 50 years | 2 | participants | |
| Number of Participants With Adverse Events (AEs) According to Baseline Characteristics | BeneFIX | Gender: Male | 9 | participants | |
| Number of Participants With Adverse Events (AEs) According to Baseline Characteristics | BeneFIX | Gender: Female | 0 | participants | |
| Number of Participants With Adverse Events (AEs) According to Baseline Characteristics | BeneFIX | Pediatric status: < 12 years | 0 | participants | |
| Number of Participants With Adverse Events (AEs) According to Baseline Characteristics | BeneFIX | Pediatric status: >= 12 years | 9 | participants |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BeneFIX | 183 | |
| Overall Study | Treated | BeneFIX | 178 | |
| Overall Study | COMPLETED | BeneFIX | 112 | |
| Overall Study | NOT COMPLETED | BeneFIX | 71 |
Source ClinicalTrials.gov
Adverse events11
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 | Stomatitis | Gastrointestinal disorders | BeneFIX | 1 | 178 | |
| other | Cellulitis | Infections and infestations | BeneFIX | 1 | 178 | |
| other | Nasopharyngitis | Infections and infestations | BeneFIX | 1 | 178 | |
| other | Alanine aminotransferase increased | Investigations | BeneFIX | 1 | 178 | |
| other | Aspartate aminotransferase increased | Investigations | BeneFIX | 1 | 178 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | BeneFIX | 1 | 178 | |
| other | Headache | Nervous system disorders | BeneFIX | 1 | 178 | |
| serious | Drug ineffective | General disorders | BeneFIX | 1 | 178 | |
| serious | Haemophilic arthropathy | Musculoskeletal and connective tissue disorders | BeneFIX | 1 | 178 | |
| serious | Gastrointestinal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | BeneFIX | 1 | 178 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BeneFIX | ||
| Total, other adverse events | BeneFIX | 5 | 178 |
| Total, serious adverse events | BeneFIX | 4 | 178 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00484185
GET https://conductscience.org/api/trials/v1/NCT00484185/results?page=2