At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3 enrolled
Drug / intervention
PF-06462700biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY 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
In Brief
A Phase 3 clinical trial evaluating PF-06462700 for Aplastic Anemia. Completed, enrolled 3 participants across 3 sites.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAplastic Anemia
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
202120222023202420252026
First PostedApr 2020
Enrollment StartJul 2020
Primary CompletionJan 2021
Study CompletionApr 2021
TodayJul 2026
First PostedApr 17, 2020
Enrollment StartJul 25, 2020
Primary CompletionJan 22, 2021
Study CompletionApr 19, 2021
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.2 years ago
Interventions
PF-06462700biological
PF-06462700 is classified as an immunosuppressant/ immunosuppressive agent. It is the purified, concentrated, and sterile gamma globulin, primarily monomeric immunoglobulin G (IgG), from hyperimmune serum of horses that are immunized with human thymus lymphocytes.