2 and older, any sex, with Aplastic Anemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Hematologic Response at Week 12Primary· Week 12 Follow-up Visit
Hematologic response was considered to be "effective" when 2 or more of the following criteria were met: absolute neutrophil count greater than or equal to (\>=) 500 per microliters, platelet count \>=20,000 per microliters and reticulocyte count \>=60,000 per microliters was observed. In this outcome measure, number of participants with hematologic response classified as effective and not effective were reported. Improvement in counts that were dependent upon exogenously administered growth factors or transfusion, was not considered as fulfilling response criteria.
Effective
Group
Value
95% CI
PF-06462700
2
Not Effective
Group
Value
95% CI
PF-06462700
1
Number of Participants With Hematologic Response at Week 24Secondary· Week 24 Follow-up Visit
Hematologic response was considered to be "effective" when 2 or more of the following criteria were met: absolute neutrophil count \>=500 per microliters, platelet count \>=20,000 per microliters and reticulocyte count \>=60,000 per microliters was observed. In this outcome measure, number of participants with hematologic response classified as effective and not effective were reported. Improvement in counts that were dependent upon exogenously administered growth factors or transfusion, was not been considered as fulfilling response criteria.
Effective
Group
Value
95% CI
PF-06462700
2
Not Effective
Group
Value
95% CI
PF-06462700
1
Absolute Neutrophil Count at Day 4, Weeks 1, 2, 4, 6, 8, 10, 12, 24Secondary· Treatment: Day 4; Follow-up: Week 1, 2, 4, 6, 8, 10, 12, 24
Group
Value
95% CI
PF-06462700
NA
Platelet Count at Day 4, Weeks 1, 2, 4, 6, 8, 10, 12, 24Secondary· Treatment: Day 4; Follow-up: Week 1, 2, 4, 6, 8, 10, 12, 24
Group
Value
95% CI
PF-06462700
NA
Reticulocyte Count at Day 4, Weeks 1, 2, 4, 6, 8, 10, 12, 24Secondary· Treatment: Day 4; Follow-up: Week 1, 2, 4, 6, 8, 10, 12, 24
Group
Value
95% CI
PF-06462700
NA
Number of Participants Who Survived During the StudySecondary· Screening (up to 28 days prior to Day 1 of treatment) up to 24 weeks of follow-up (approximately up to 28 weeks)
In this outcome measure, number of participants who survived during the study were observed.
Group
Value
95% CI
PF-06462700
3
Number of Participants With Transfusion Independence at Weeks 12 and 24Secondary· Week 12 Transfusion Independence: Day 1 of Treatment up to Week 12 Follow-up Visit (approximately 12 weeks); Week 24 Transfusion Independence: Day after Week 12 Follow-up visit to Week 24 Follow-up Visit (approximately 12 weeks)
Transfusion independence at Week 12 was defined as when participants did not have any transfusion records from the time of the first dose of the investigational product at Day 1 to the day of Week 12 follow-up visit (inclusive). Transfusion independence at Week 24 was defined as when participants did not have any transfusion records from the day after Week 12 follow-up visit to the day of Week 24 follow-up visit (inclusive).
Week 12 Transfusion Independence
Group
Value
95% CI
PF-06462700
0
Week 24 Transfusion Independence
Group
Value
95% CI
PF-06462700
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Screening up to 24 weeks of follow-up (approximately up to 28 weeks).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of the study is to assess the efficacy and safety of PF-06462700 administered intravenously at 40 mg/kg/day for 4 days in Japanese participants with moderate and above aplastic anemia for making an approval application in Japan.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 27 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04350606.