ong-term study of KW-0761 in patients with HAM

Phase 2

• Conditions: HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)

• Registration Number: JPRN-UMIN000019942
• Lead Sponsor: St. Marianna University School of Medicine Hospital

Brief Summary

https://doi.org/10.1093/brain/awad139

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-26
• Study Completion: 2021-07-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified