Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| B1831002 | Other Identifier | Pfizer | |
| 3082B2-3315-WW |
Not provided
Not provided
Not provided
See termination reason in detailed description.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will be investigating the safety and efficacy of Xyntha (moroctocog alfa (AF-CC)) in male patients less than 6 years old. Annualized bleeding rates and physician / caregiver assessments of responses to treatment will be characterized. FVIII inhibitor levels will be assessed throughout the study.
The study was terminated on 22 Sept 2009 due to competition with another Wyeth study for a similar patient population. The decision to terminate the trial was not based on any safety issues.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| open label | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moroctocog alfa | Biological | Patients will receive Moroctocog alfa according to their investigator's prescription. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Factor VIII (FVIII) Inhibitor Development | Incidence of inhibitor development was defined as any result determined positive at a central laboratory (Bethesda inhibitor titer of >=0.6 BU/mL) using Nijmegen modification of the Bethesda assay. | Baseline to 24 months or early withdrawal. |
| Percentage of Participants With Less Than Expected Therapeutic Effects (LETE) in the On-Demand Setting | LETE in the on-demand setting was based on the response to the treatment of a bleeding episode. LETE in the on-demand setting occurred if the participant recorded 2 successive "No Response" ratings (indicated there was no improvement at all between infusions or during the 24 hour interval following an infusion, or condition worsened) after 2 successive Xyntha infusions, respectively. The infusions was to be administered within 24 hours (=<24 hours) of each other for the treatment of the same bleeding event in the absence of confounding factor. | Baseline to 24 months or early withdrawal. |
| Percentage of Participants With LETE in the Prophylaxis Setting | The LETE in the prophylaxis setting was the occurrence of a bleed. LETE in the prophylaxis setting occurred if there was a spontaneous bleed within 48 hours (=<48 hours) after a regularly scheduled prophylactic dose of Xyntha (which was not used to treat a bleed) in the absence of confounding factors. | Baseline to 24 months or early withdrawal. |
| Percentage of Participants With Low Recovery LETE | The LETE could be considered lower than expected recovery of FVIII in the opinion of the investigator following infusion of Xyntha in the absence of confounding factors. | Baseline to 24 months or early withdrawal. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Annualized Bleed Rate (ABR) | An annualized bleeding rate (ABR) for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the electronic Infusion Log Diary), divided by his total therapy duration (in days), and then multiplied by 365.25. | Baseline to 24 months or early withdrawal. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
Not provided
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Not provided
The study was planned to be conducted in major hemophilia centers in North America, Latin America, and Asia-Pacific regions. Seven (7) sites were initiated; however, recruitment occurred at only 1 site in United State of America (USA) between June 2009 to December 2009. The study was terminated by the Sponsor.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Xyntha | Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Xyntha | Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Factor VIII (FVIII) Inhibitor Development | Incidence of inhibitor development was defined as any result determined positive at a central laboratory (Bethesda inhibitor titer of >=0.6 BU/mL) using Nijmegen modification of the Bethesda assay. | Intent-to-treat (ITT) population: Participants who had received at least 1 dose of Xyntha. | Posted | Number | Percentage of participants | Baseline to 24 months or early withdrawal. |
|
|
AEs and SAEs were collected from the signing of the informed consent form to minimum 15 days after the last administered dose of Xyntha.
Safety population = subjects who received at least 1 dose of Xyntha. The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Xyntha | Participants received intravenous infusion (s) of Xyntha as per dosage and administration frequency as prescribed by the treating physician. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal fistula | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infusion site extravasation | General disorders | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D006467 | Hemophilia A |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C427184 | recombinant factor VIII SQ |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Number of Xyntha Infusions Needed to Treat Each New Bleed | The data from the electronic Infusion Log Diary plus the Test Article case report form (CRF) was used to determine the number of infusions administered to treat a bleed. This was calculated by adding the initial 'for a new bleed' (on demand) infusion to any subsequent (on demand) infusions for the (same) 'previously treated bleed'. An on-demand infusion for a 'previously treated bleed' was counted toward the bleed with the most recent start time prior to that infusion. | Baseline to 24 months or early withdrawal. |
| Response to First On-demand Xyntha Treatment for All New Bleeds as Assessed by the Caregiver | A 4-point response scale to be completed is as defined as follows: (Excellent: definite pain relief/improvement in signs of bleeding starting within 8 hrs after an infusion, with no additional infusion; Good: definite pain relief/improvement in signs of bleeding starting within 8 hrs or following the infusion; Moderate: probable/slight improvement starting after 8 hours following the infusion; No Response: no improvement at all between infusions). | Baseline to 24 months or early withdrawal |
| Mean Number of Breakthrough (Spontaneous/Non-traumatic) Bleeds | The number of breakthrough (spontaneous/non-traumatic) bleeds within 48 hours following a prophylaxis dose of Xyntha was summarized. The data from the electronic Infusion Log Diary plus the Test Article CRF was used to determine the number of infusions administered to treat a new bleed, counting only those infusions administered =<48 hours after an infusion marked as 'prophylaxis' (which had no associated bleed). | Baseline to 24 months or early withdrawal. |
| Month |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Percentage of Participants With Less Than Expected Therapeutic Effects (LETE) in the On-Demand Setting | LETE in the on-demand setting was based on the response to the treatment of a bleeding episode. LETE in the on-demand setting occurred if the participant recorded 2 successive "No Response" ratings (indicated there was no improvement at all between infusions or during the 24 hour interval following an infusion, or condition worsened) after 2 successive Xyntha infusions, respectively. The infusions was to be administered within 24 hours (=<24 hours) of each other for the treatment of the same bleeding event in the absence of confounding factor. | The study was terminated, analysis was not conducted. | Posted | Baseline to 24 months or early withdrawal. |
|
|
| Primary | Percentage of Participants With LETE in the Prophylaxis Setting | The LETE in the prophylaxis setting was the occurrence of a bleed. LETE in the prophylaxis setting occurred if there was a spontaneous bleed within 48 hours (=<48 hours) after a regularly scheduled prophylactic dose of Xyntha (which was not used to treat a bleed) in the absence of confounding factors. | The study was terminated, analysis was not conducted. | Posted | Baseline to 24 months or early withdrawal. |
|
|
| Primary | Percentage of Participants With Low Recovery LETE | The LETE could be considered lower than expected recovery of FVIII in the opinion of the investigator following infusion of Xyntha in the absence of confounding factors. | The study was terminated, analysis was not conducted. | Posted | Baseline to 24 months or early withdrawal. |
|
|
| Secondary | Mean Annualized Bleed Rate (ABR) | An annualized bleeding rate (ABR) for each participant was calculated as the number of bleeds requiring administration of FVIII replacement product (taken from the electronic Infusion Log Diary), divided by his total therapy duration (in days), and then multiplied by 365.25. | The study was terminated, analysis was not conducted. | Posted | Baseline to 24 months or early withdrawal. | Bleeds | Bleeds |
|
|
| Secondary | Number of Xyntha Infusions Needed to Treat Each New Bleed | The data from the electronic Infusion Log Diary plus the Test Article case report form (CRF) was used to determine the number of infusions administered to treat a bleed. This was calculated by adding the initial 'for a new bleed' (on demand) infusion to any subsequent (on demand) infusions for the (same) 'previously treated bleed'. An on-demand infusion for a 'previously treated bleed' was counted toward the bleed with the most recent start time prior to that infusion. | The study was terminated, analysis was not conducted. | Posted | Baseline to 24 months or early withdrawal. | Number of Infusions | Number of Infusions |
|
|
| Secondary | Response to First On-demand Xyntha Treatment for All New Bleeds as Assessed by the Caregiver | A 4-point response scale to be completed is as defined as follows: (Excellent: definite pain relief/improvement in signs of bleeding starting within 8 hrs after an infusion, with no additional infusion; Good: definite pain relief/improvement in signs of bleeding starting within 8 hrs or following the infusion; Moderate: probable/slight improvement starting after 8 hours following the infusion; No Response: no improvement at all between infusions). | The study was terminated, analysis was not conducted. | Posted | Baseline to 24 months or early withdrawal |
|
|
| Secondary | Mean Number of Breakthrough (Spontaneous/Non-traumatic) Bleeds | The number of breakthrough (spontaneous/non-traumatic) bleeds within 48 hours following a prophylaxis dose of Xyntha was summarized. The data from the electronic Infusion Log Diary plus the Test Article CRF was used to determine the number of infusions administered to treat a new bleed, counting only those infusions administered =<48 hours after an infusion marked as 'prophylaxis' (which had no associated bleed). | The study was terminated, analysis was not conducted. | Posted | Baseline to 24 months or early withdrawal. | Bleeds | Bleeds |
|
|
| 1 |
| 1 |
| 1 |
| 1 |
| Anal abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Anal abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |