Trials / Completed
CompletedNCT05137847
A Study of Remitoro in Participants With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
Post-marketing Observational Study of Remitoro® Intravenous Injection 300 μg - Safety of Remitoro in Patients With Recurrent or Refractory Peripheral T Cell Lymphoma and Cutaneous T Cell Lymphoma (All Case Study)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 118 (actual)
- Sponsor
- Eisai Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The primary purpose of the study is to investigate the incidence of adverse drug reactions (ADRs) (ADR of special interest: capillary leak syndrome, infusion reaction, rhabdomyolysis, myelosuppression, infection, hepatic dysfunction, visual impairment/color blindness, ischemic heart disease/arrhythmia/cardiac failure, and severe skin disorders).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Remitoro | Intravenous infusion. |
Timeline
- Start date
- 2021-05-24
- Primary completion
- 2023-03-17
- Completion
- 2023-03-17
- First posted
- 2021-11-30
- Last updated
- 2023-12-12
Locations
3 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT05137847. Inclusion in this directory is not an endorsement.