Trial Outcomes & Findings for Understanding Hemophilia A and B Drug Dosage Administration Patterns (NCT NCT03248141)
NCT ID: NCT03248141
Last Updated: 2019-05-20
Results Overview
Recruitment status
TERMINATED
Target enrollment
11 participants
Primary outcome timeframe
From baseline up to end of study (6 months)
Results posted on
2019-05-20
Participant Flow
Out of 41 screened participants, 11 were enrolled in this study. Study got terminated afterwards due to difficulty in enrolling the targeted number of participants.
Participant milestones
| Measure |
Hemophilia A Cohort
Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to \[\<=\]5 percent\[%\] or severe: clotting factor level of less than \[\<\]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months.
|
Hemophilia B Cohort
Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level \<=5% or severe: clotting factor level of \<1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
0
|
|
Overall Study
COMPLETED
|
11
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Hemophilia A Cohort
n=11 Participants
Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to \[\<=\]5 percent\[%\] or severe: clotting factor level of less than \[\<\]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months.
|
Hemophilia B Cohort
Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level \<=5% or severe: clotting factor level of \<1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=11 Participants
|
0 Participants
|
2 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=11 Participants
|
0 Participants
|
9 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
0 Participants
|
0 Participants
n=11 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=11 Participants
|
0 Participants
|
0 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=11 Participants
|
0 Participants
|
11 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: From baseline up to end of study (6 months)Population: Data was not collected and analyzed for this outcome measure since very less number of participants were enrolled prior to study termination.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From baseline up to end of study (6 months)Population: Data was not collected and analyzed for this outcome measure since very less number of participants were enrolled prior to study termination.
Outcome measures
Outcome data not reported
Adverse Events
Hemophilia A Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Hemophilia B Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER