Trials / Completed
CompletedNCT04350606
A Study to Assess Efficacy and Safety of PF-06462700 in Japanese Participants With Aplastic Anemia
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PF-06462700 | 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. |
Timeline
- Start date
- 2020-07-25
- Primary completion
- 2021-01-22
- Completion
- 2021-04-19
- First posted
- 2020-04-17
- Last updated
- 2022-04-27
- Results posted
- 2022-04-27
Locations
3 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04350606. Inclusion in this directory is not an endorsement.