Trials / Terminated
TerminatedNCT03191526
A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM)
A Phase 3 Multicenter, Randomized, Double-Blind and Placebo-Controlled Study, and Open Study of KW-0761 in Patients With HTLV-1 Associated Myelopathy (HAM)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to assess the efficacy and safety of KW-0761 after intravenous injections in subjects with HTLV-1 associated myelopathy (HAM) in Japan.
Detailed description
The effects of KW-0761 (0.3 mg/kg) on the Osame's motor disability score (OMDS) of subjects with HTLV-1 associated myelopathy (HAM).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KW-0761 0.3 mg/kg IV | Intravenous injection every 12 weeks. |
| DRUG | Placebo (saline) | Intravenous injection every 12 weeks. |
Timeline
- Start date
- 2017-05-22
- Primary completion
- 2019-06-06
- Completion
- 2021-08-31
- First posted
- 2017-06-19
- Last updated
- 2022-04-14
Locations
16 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03191526. Inclusion in this directory is not an endorsement.