Trial · NCT02492984
PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A
NCT02492984, Phase 4, Completed, Pfizer; results first posted 2017-04-04
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A. Trials, record NCT02492984. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02492984
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Hemophilia A
- NCT number
- NCT02492984
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 85 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Hemophilia A
- Interventions
- Intravenous infusions of Xyntha
- First posted
- 2015-07-09
- Last updated
- 2017-04-04
- Other registries' IDs
- eudract:2015-005040-33
- Results first posted
- 2017-04-04
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Factor VIII (FVIII) Inhibitors | From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 exposure days [EDs] whichever occurred first). | Percentage of participants with the product medically important event (MIE) (FVIII inhibitor development during the study). |
| Secondary | Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first). | An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. 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. An AE was considered treatment emergent if it started for the first time in a participant on or after the first day of active treatment, or the event started before the first day of active treatment but increased in severity during active treatment. AEs included both SAEs and non-serious AEs. |
| Secondary | Response Assessment of On-Demand Treatment of Bleeds | From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first. | The proportion of infusions (initial and subsequent for a bleed) in each response category (excellent, good, moderate, no response) was reported. 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 1 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 1 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 Infusions Needed to Treat Each New Bleed for On-Demand Treatment | From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first. | The number of Xyntha infusions administered to treat a bleed was determined. This was calculated by adding the on-demand initial treatment and any on-demand follow-up infusions for the same bleed (same bleed start date/time). |
| Secondary | Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group | From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first. | The number of bleeds resolved with 1, 2, 3, 4, or \>4 infusions was reported for each of the categories (1, 2, 3, 4, or \>4 infusions needed to treat the bleed), in which the numerator was the number of bleeds falling into each category, and the denominator was the total number of new bleeds across all participants. |
| Secondary | Hemostatic Efficacy for Surgical Prophylaxis Treatment | From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery) | Assessment of hemostatic efficacy was determined by the investigator and/or surgeon using the 4 point Surgical Hemostasis Efficacy Rating Scale. Excellent: Achieved hemostasis comparable to that expected after similar surgery in a non hemophilic participant. Good: Prolonged time to hemostasis, with somewhat increased bleeding compared to that expected after similar surgery in a non hemophilic participant. Moderate: Obviously delayed hemostasis, but manageable with additional infusions. No Response: No hemostatic response. The percentage of observations in each hemostatic efficacy response category (excellent, good, moderate, none) was reported. |
| Secondary | Actual Estimated Blood Loss for Surgical Prophylaxis Treatment | From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery) | Number of participants with blood loss in each category (Abnormal, Normal, and Absence). Blood loss during the intraoperative and the postoperative period were assessed by investigator or surgeon, which were rated as Abnormal, Normal, and Absence. Abnormal blood loss meant the blood loss was higher over the expectation for the non hemophilic participant. |
| Secondary | Number of Participants With Transfusion Requirement for Surgical Prophylaxis Treatment | From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery) | Number of participants with transfusion requirement for surgical prophylaxis treatment. Transfusion requirements during the intraoperative and the postoperative period were assessed by investigator or surgeon. The number of units and types of blood products transfused were recorded if applicable. |
| Secondary | Average Infusion Dose and Total Factor VIII Consumption for On-Demand Treatment and Surgical Prophylaxis Treatment | On-Demand Group: Day 1 up to 6 months or 50 EDs whichever occurred first. Surgical Prophylaxis Group: Day of surgery to postoperative period. The duration of postoperative period is specified in previous endpoints. | The total amount (IU) infused for each Xyntha infusion recorded in the study drug infusion log case report form (CRF) was summed to calculate the total factor VIII consumption for each participant. The average infusion dose for each participant was calculated as his total factor VIII consumption (in IU) divided by the number of infusions administered. The total factor VIII consumption, divided by number of infusions, was summarized similarly to average infusion dose (IU). |
| Secondary | Percentage of Less Than Expected Therapeutic Effect (LETE) in the On-Demand Setting | From Day 1 up to participants had received treatment for 6 months or participants had achieved 50 EDs whichever occurred first. | LETE occurred in the on-demand setting if 2 successive "No Response" ratings were recorded after 2 successive Xyntha drug infusions, respectively.The infusions must have been administered within 24 hours (less than or equal to 24 hours) of each other for treatment of the same bleeding event in the absence of confounding factors (prespecified). Therefore, LETE in the on-demand setting was based on the response to treatment of a bleeding episode (including those occurring during the surgical prophylaxis period). Note that on-demand treatments administered during the surgical prophylaxis period were also to be included. |
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 | Percentage of Participants With Factor VIII (FVIII) Inhibitors | From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 exposure days [EDs] whichever occurred first). | The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | From Day 1 up to 28 calendar days after End of Treatment (participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first). | The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study. | participants | NUMBER |
| SECONDARY | Response Assessment of On-Demand Treatment of Bleeds | From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first. | Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the surgical prophylaxis group. | percentage of infusions | NUMBER |
| SECONDARY | Number of Infusions Needed to Treat Each New Bleed for On-Demand Treatment | From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first. | Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the surgical prophylaxis group. | infusions | MEAN |
| SECONDARY | Frequency of Xyntha Infusions to Treat Each New Bleed for On-Demand Group | From Day 1 up to participants had received treatment for 6 months or when participants had achieved 50 EDs whichever occurred first. | Participants with a bleed during the study for which on-demand treatment with Xyntha was administered. The data for this outcome was not planned to be analyzed for the surgical prophylaxis group. | percentage of bleeds | NUMBER |
| SECONDARY | Hemostatic Efficacy for Surgical Prophylaxis Treatment | From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery) | Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the on-demand group. | percentage of observations | NUMBER |
| SECONDARY | Actual Estimated Blood Loss for Surgical Prophylaxis Treatment | From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery) | Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the on-demand group. Number of participants analyzed signifies participants evaluable for this outcome measure. | partcipants | NUMBER |
| SECONDARY | Number of Participants With Transfusion Requirement for Surgical Prophylaxis Treatment | From day of surgery to postoperative period (at least 1-3 days post operation or until adequate wound healing for minor surgery or 4-6 days post operation or until threat resolved or adequate wound healing for major surgery) | Surgical prophylaxis participants during their surgical prophylaxis period. The data for this outcome was not planned to be analyzed for the on-demand group. | participants | NUMBER |
| SECONDARY | Average Infusion Dose and Total Factor VIII Consumption for On-Demand Treatment and Surgical Prophylaxis Treatment | On-Demand Group: Day 1 up to 6 months or 50 EDs whichever occurred first. Surgical Prophylaxis Group: Day of surgery to postoperative period. The duration of postoperative period is specified in previous endpoints. | All participants who received at least one dose of Xyntha during the study | International Unit (IU) | MEAN |
| SECONDARY | Percentage of Less Than Expected Therapeutic Effect (LETE) in the On-Demand Setting | From Day 1 up to participants had received treatment for 6 months or participants had achieved 50 EDs whichever occurred first. | The safety analysis set was defined as all participants who received at least one dose of Xyntha during the study. | percentage of bleeding episodes | NUMBER |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Factor VIII (FVIII) Inhibitors | On-Demand Group | 8.22 | 95% Confidence Interval 3.08 to 17.04 | percentage of participants | |
| Percentage of Participants With Factor VIII (FVIII) Inhibitors | Surgical Prophylaxis Group | 7.14 | 95% Confidence Interval 0.18 to 33.87 | percentage of participants | |
| Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | On-Demand Group | Participants with AEs | 65 | participants | |
| Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Surgical Prophylaxis Group | Participants with AEs | 10 | participants | |
| Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | On-Demand Group | Participants with SAEs | 7 | participants | |
| Number of Participants With All Causality Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | Surgical Prophylaxis Group | Participants with SAEs | 1 | participants | |
| Response Assessment of On-Demand Treatment of Bleeds | On-Demand Group | Excellent | 46.9 | percentage of infusions | |
| Response Assessment of On-Demand Treatment of Bleeds | On-Demand Group | Good | 40.0 | percentage of infusions | |
| Response Assessment of On-Demand Treatment of Bleeds | On-Demand Group | Moderate | 12.7 | percentage of infusions | |
| Response Assessment of On-Demand Treatment of Bleeds | On-Demand Group | No Response | 0.3 | percentage of infusions |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | On-Demand Group | 73 | |
| Overall Study | STARTED | Surgical Prophylaxis Group | 14 | |
| Overall Study | COMPLETED | On-Demand Group | 70 | |
| Overall Study | COMPLETED | Surgical Prophylaxis Group | 14 | |
| Overall Study | NOT COMPLETED | On-Demand Group | 3 | |
| Overall Study | NOT COMPLETED | Surgical Prophylaxis Group | 0 |
Source ClinicalTrials.gov
Adverse events114
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 | Anaemia | Blood and lymphatic system disorders | On-Demand Group | 0 | 73 | |
| other | Anaemia | Blood and lymphatic system disorders | Surgical Prophylaxis Group | 2 | 14 | |
| other | Anaemia | Blood and lymphatic system disorders | Total | 2 | 85 | |
| other | Abdominal distension | Gastrointestinal disorders | On-Demand Group | 0 | 73 | |
| other | Abdominal distension | Gastrointestinal disorders | Surgical Prophylaxis Group | 1 | 14 | |
| other | Abdominal distension | Gastrointestinal disorders | Total | 1 | 85 | |
| other | Constipation | Gastrointestinal disorders | On-Demand Group | 1 | 73 | |
| other | Constipation | Gastrointestinal disorders | Surgical Prophylaxis Group | 1 | 14 | |
| other | Constipation | Gastrointestinal disorders | Total | 2 | 85 | |
| other | Nausea | Gastrointestinal disorders | On-Demand Group | 0 | 73 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | On-Demand Group | ||
| Total, all-cause mortality | Surgical Prophylaxis Group | ||
| Total, all-cause mortality | Total | ||
| Total, other adverse events | On-Demand Group | 62 | 73 |
| Total, other adverse events | Surgical Prophylaxis Group | 9 | 14 |
| Total, other adverse events | Total | 70 | 85 |
| Total, serious adverse events | On-Demand Group | 7 | 73 |
| Total, serious adverse events | Surgical Prophylaxis Group | 1 | 14 |
| Total, serious adverse events | Total | 8 | 85 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33269010 | 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/NCT02492984
GET https://conductscience.org/api/trials/v1/NCT02492984/results?page=2