HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)
Conditions
Interventions
Sponsors
St. Marianna University School of Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The patient who completed the week 28 visit in Phase IIa, which counts from Day1 of Phase IIa (2) The patient gives of his/her own free will consent to move forward to the long-term study
Exclusion criteria
Exclusion criteria: (1)Patients with a history of acute or chronic hepatitis or hepatic cirrhosis (2)Patients with a history of tuberculosis or with active tuberculosis (3)Patients who have developed a myocardial infarction within 12 months of enrollment (4)Patients with a history of allergic reaction to antibody-based treatments (5)Patients who have taken immunosuppressant drugs or interferon-a within 6 months of enrollment (6)Patients who have undergone live or attenuated/inactivated vaccinations within four weeks of enrollment, or who plan to be vaccinated during the course of the study (7)Patients with serious complicating conditions (8)Patients with any ailment that could be exacerbated by the administration of KW-0761 (9)Patients with a history of cancer with complications. However, the following patients are not excluded: - radically resected solid tumor which have not recurred within the five years preceding enrollment - radically resected basal cell carcinoma of the skin, squamous cell carcinoma (except malignant melanoma), non-invasive cervix carcinoma, and carcinoma in situ in the gastrointestinal tract or corpus of the uterus even if recurrence has occurred within five years of enrollment (10)Patients with ATL (11)Patients who are pregnant, breastfeeding, or may become pregnant (12)Patients taking multivitamins (prosultiamine, vitamin C) or supplements such as fucoidan, catechin, or pentosan polysulfate within two weeks of enrollment (13)Patients who have taken other experimental drugs within four months of giving informed consent (14)Patients with spinal cord compression lesion complications such as from cervical spine disease, intervertebral disc herniation, yellow ligament ossification (15)Patients with mental disabilities, epilepsy, or dementia (16)HBsAg-, anti-HBc- or HBV-DNA-positive patients (17)HCV antibody-positive patients (18)HIV antibody-positive patients (19)Patients considered unqualified to join the study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: Presence or absence and nature of any adverse effects | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: -The duration of the effectiveness against infected cells (where effective is defined as a drop to 40% or less the peripheral blood HTLV-1 proviral load before treatment with KW-0761 during Phase I.) -Lack of decline in performance during the 10-meter timed walk. (A 100% or more of increase in time compared with the baseline, before the KW-0761 treatment during Phase I, is defined as disease progression.) | — |
Countries
Japan
Contacts
Public ContactYuki Ohta
St. Marianna University School of Medicine St. Marianna University School of Medicine, Center for Clinical & Translational Science
Outcome results
None listed