Trial · NCT00884390
Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings
NCT00884390, Phase 4, Terminated, Pfizer; results first posted 2014-09-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings. Trials, record NCT00884390. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00884390
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating Safety Of Patients Switching To ReFacto AF In Usual Care Settings
- NCT number
- NCT00884390
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 208 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Hemophilia A
- Interventions
- moroctocog alfa (AF-CC) (ReFacto AF), Laboratory tests
- First posted
- 2009-04-20
- Last updated
- 2014-09-01
- Results first posted
- 2014-09-01
- Limitations and caveats
The study was terminated early by agreement with the EMA before full recruitment was attained, but this is not considered to affect the overall results and the ability of the study to address its objectives.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Clinically Significant Factor VIII Inhibitor Development | 100 exposure days to study medication (approx. 2 years) | Number of participants with clinically significant FVIII inhibitor development after switching from ReFacto to moroctocog alfa (AF-CC). Clinically significant inhibitors are defined as a central laboratory confirmed positive inhibitor (≥ 0.6 Bethesda unit (BU) using the Nijmegen modification of the Bethesda assay present at 2 consecutive blood draws within a 6-week interval) and within 28 days before the initial or within 28 days following the second positive FVIII inhibitor sample collection one of the following: the need for the participant to administer alternative hemostatic products in order to achieve sufficient efficacy, or ≥2 adverse event reports of decreased drug effect (or other adverse event indicating a decrease in the efficacy of the test article). The blood sample collection for these results must also be between the date of first dose of study medication and 28 days after the last dose of study medication. |
| Secondary | Annualized Bleeding Rates (ABRs) | 100 exposure days to study medication (approx. 2 years) | An ABR for each participant will be calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the Infusion Log Diary case report form), divided by his total therapy duration (in days), then multiplied by 365.25. |
| Secondary | Response Assessment of First On-demand Treatment of New Bleeds | 100 exposure days to study medication (approx. 2 years) | A 4-point scale of assessment of 'on-demand' treatment (administration of an unscheduled bolus infusion of Refacto-AF to stop bleeding) is defined as: * Excellent: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with no additional infusion administered. * Good: Definite pain relief and/or improvement in signs of bleeding starting within 8 hours after an infusion, with at least one additional infusion administered for complete resolution of the bleeding episode; or, Definite pain relief and/or improvement in signs of bleeding starting after 8 hours following the infusion, with no additional infusion administered. * Moderate: Probable or slight improvement starting after 8 hours following the infusion, with at least one additional infusion administered for complete resolution of the bleeding episode. * No Response: No improvement at all between infusions or during the 24-hour interval following an infusion, or condition worsens. |
| Secondary | Number of ReFacto AF Infusions to Treat Each New Bleed | 100 exposure days to study medication (approx. 2 years) | The Infusion Log Diary case report form (CRF) was used to determine the number of test article infusions administered to treat a bleed. This was calculated by adding the initial (on-demand) infusion to any subsequent (on-demand) infusions for the same bleed (same bleed start date/time). |
| Secondary | Number of Bleeding Episodes Occurring ≤48 Hours After a Prophylaxis Infusion | 100 exposure days to study medication (approx. 2 years) | First, the bleed start time from the Infusion Log Diary CRF was used to determine the number of breakthrough bleeds that occurred ≤48 hours after an infusion marked as "Prophylaxis" (which had no associated bleed). If there was more than 1 bleed location (ie, ankle and joint) with identical bleed start date and time, it was treated as 1 bleed occurrence. If a response was given, or if a bleed time was given, but "On Demand" was not listed as "treatment type", it was still counted as an on-demand bleed for analyses/summaries. Bleeding episodes were not categorized as spontaneous (atraumatic) or traumatic. |
| Secondary | Number of Participants With Breakthrough Bleeds | 100 exposure days to study medication (approx. 2 years) | The number of participants with any breakthrough bleed was reported. |
| Secondary | Total Factor Consumption (TFC) Following a Non-prophylaxis Regimen at Baseline for All Participants | 100 exposure days to study medication (approx. 2 years) | The total amount (in International Units \[IU\]) infused for each test article infusion recorded in the Infusion Log Diary CRF was summed to calculate the TFC for each participant. |
| Secondary | TFC Following a Prophylaxis Regimen at Baseline for All Participants | 100 exposure days to study medication (approx. 2 years) | The total amount (in IU) infused for each test article infusion recorded in the Infusion Log Diary CRF was summed to calculate the TFC for each participant. |
| Secondary | Average Infusion Dose | 100 exposure days to study medication (approx. 2 years) | The average infusion dose for each participant was calculated as his total factor consumption (in IU) divided by the number of infusions administered. Summary statistics were reported for both of these variables separately for those participants classified at baseline as following an on-demand regimen, and for those on a primary or secondary prophylaxis regimen. |
| Secondary | Incidence of Less-than-expected-therapeutic Effect (LETE) in the On-demand Setting | 100 exposure days to study medication (approx. 2 years) | The calculation of incidence of on-demand LETE used the number of bleeds identified as, or with a result of, LETE as the numerator (from the On Demand LETE CRF), and the denominator was the number of bleeding episodes treated in an on-demand setting. This denominator could include new bleeding episodes in prophylaxis participants breakthrough bleeds), and if subsequent on-demand doses for such a bleed met the on-demand LETE criteria, then an on-demand LETE was reported. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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 Clinically Significant Factor VIII Inhibitor Development | 100 exposure days to study medication (approx. 2 years) | All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses. | Number of participants | NUMBER |
| SECONDARY | Annualized Bleeding Rates (ABRs) | 100 exposure days to study medication (approx. 2 years) | All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses. | Number of bleeds | MEAN |
| SECONDARY | Response Assessment of First On-demand Treatment of New Bleeds | 100 exposure days to study medication (approx. 2 years) | All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses. | Number of observations | NUMBER |
| SECONDARY | Number of ReFacto AF Infusions to Treat Each New Bleed | 100 exposure days to study medication (approx. 2 years) | All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses. | Number of Infusions | MEAN |
| SECONDARY | Number of Bleeding Episodes Occurring ≤48 Hours After a Prophylaxis Infusion | 100 exposure days to study medication (approx. 2 years) | All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses. | bleeds | NUMBER |
| SECONDARY | Number of Participants With Breakthrough Bleeds | 100 exposure days to study medication (approx. 2 years) | All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses. | participants | NUMBER |
| SECONDARY | Total Factor Consumption (TFC) Following a Non-prophylaxis Regimen at Baseline for All Participants | 100 exposure days to study medication (approx. 2 years) | All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses. | International Units (IU) | MEAN |
| SECONDARY | TFC Following a Prophylaxis Regimen at Baseline for All Participants | 100 exposure days to study medication (approx. 2 years) | All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses. | IU | MEAN |
| SECONDARY | Average Infusion Dose | 100 exposure days to study medication (approx. 2 years) | All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses. | IU | MEAN |
| SECONDARY | Incidence of Less-than-expected-therapeutic Effect (LETE) in the On-demand Setting | 100 exposure days to study medication (approx. 2 years) | All enrolled participants who took at least 1 dose of ReFacto AF study drug were included in the safety and efficacy analyses. | percentage of bleeds LETE | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group32
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 Clinically Significant Factor VIII Inhibitor Development | ReFacto Switch | 0 | 95% Confidence Interval 0.00 to 2.49 | Number of participants | |
| Number of Participants With Clinically Significant Factor VIII Inhibitor Development | Other Switch | 0 | 95% Confidence Interval 0.00 to 5.78 | Number of participants | |
| Annualized Bleeding Rates (ABRs) | Annualized Bleed Rate | On-demand regimen (N=52) | 28.35 | Standard Deviation 18.781 | Number of bleeds |
| Annualized Bleeding Rates (ABRs) | Annualized Bleed Rate | Preventive regimen (N=2) | 1.08 | Standard Deviation 1.528 | Number of bleeds |
| Annualized Bleeding Rates (ABRs) | Annualized Bleed Rate | Primary or secondary prophylaxis regimen (N=154) | 8.43 | Standard Deviation 17.362 | Number of bleeds |
| Response Assessment of First On-demand Treatment of New Bleeds | First Infusion Per Bleed | Excellent | 1650 | Number of observations | |
| Response Assessment of First On-demand Treatment of New Bleeds | First Infusion Per Bleed | Good | 1031 | Number of observations | |
| Response Assessment of First On-demand Treatment of New Bleeds | First Infusion Per Bleed | Moderate | 191 | Number of observations | |
| Response Assessment of First On-demand Treatment of New Bleeds | First Infusion Per Bleed | No response | 26 | Number of observations | |
| Response Assessment of First On-demand Treatment of New Bleeds | First Infusion Per Bleed | Data Not Recorded | 343 | Number of observations |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ReFacto Switch | 146 | |
| Overall Study | STARTED | Other Switch | 62 | |
| Overall Study | COMPLETED | ReFacto Switch | 123 | |
| Overall Study | COMPLETED | Other Switch | 54 | |
| Overall Study | NOT COMPLETED | ReFacto Switch | 23 | |
| Overall Study | NOT COMPLETED | Other Switch | 8 |
Source ClinicalTrials.gov
Adverse events32
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 | All Participants | 32 | 208 | 44 |
| other | Influenza | Infections and infestations | All Participants | 13 | 208 | 18 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | All Participants | 26 | 208 | 69 |
| other | Haemarthrosis | Musculoskeletal and connective tissue disorders | All Participants | 24 | 208 | 86 |
| other | Limb injury | Injury, poisoning and procedural complications | All Participants | 15 | 208 | 25 |
| other | Headache | Nervous system disorders | All Participants | 21 | 208 | 47 |
| serious | Factor VIII inhibition | Blood and lymphatic system disorders | All Participants | 5 | 208 | 5 |
| serious | Acute abdomen | Gastrointestinal disorders | All Participants | 1 | 208 | 1 |
| serious | Dyspepsia | Gastrointestinal disorders | All Participants | 1 | 208 | 1 |
| serious | Haematemesis | Gastrointestinal disorders | All Participants | 1 | 208 | 1 |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | ||
| Total, other adverse events | All Participants | 90 | 208 |
| Total, serious adverse events | All Participants | 20 | 208 |
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/NCT00884390
GET https://conductscience.org/api/trials/v1/NCT00884390/results?page=2