A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM)
NCT03191526 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2022-04-14
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.
Conditions
- HTLV-1 Associated Myelopathy
Interventions
- DRUG
-
KW-0761 0.3 mg/kg IV
Intravenous injection every 12 weeks.
- DRUG
-
Placebo (saline)
Intravenous injection every 12 weeks.
Sponsors & Collaborators
-
Kyowa Kirin Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-22
- Primary Completion
- 2019-06-06
- Completion
- 2021-08-31
Countries
- Japan
Study Locations
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