|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
25 April 2022 |
|
Main ID: |
NCT04004819 |
|
Date of registration:
|
27/06/2019 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Rituximab for HTLV-1-associated Myelopathy
|
|
Scientific title:
|
Rituximab Therapy for the Patients With HTLV-1-associated Myelopathy |
|
Date of first enrolment:
|
August 15, 2019 |
|
Target sample size:
|
100 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT04004819 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
China
| | | | | | | |
|
Contacts
|
|
Name:
|
Ying Fu, MD, PhD |
|
Address:
|
|
|
Telephone:
|
13920263588 |
|
Email:
|
fuying1995@163.com |
|
Affiliation:
|
|
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Age 18-80 years
- Patients HTLV-1-associated myelopathy (tropical spastic paraparesis)
Exclusion Criteria:
- Anticipated survival of at least 3 years
- Inability to undergo neuroimaging with Magnetic Resonance
- Clinically significant hepatic disease as demonstrated by history, clinical exam
(ascites, varices), or laboratory findings (LFTs >2x normal, coagulopathy as
described)
- Comorbid conditions likely to complicate therapy including but not limited to the
following: a history of New York Heart Association class II, III, or IV Congestive
Heart Failure; end-stage acquired immune deficiency syndrome
- Pregnancy
- Malignancy (history of or active)
- Concomitant use with antineoplastic, immunosuppressive or immune modulating therapies
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
HTLV-1-associated Myelopathy
|
|
Intervention(s)
|
|
Drug: Rituximab
|
|
Primary Outcome(s)
|
|
The improvement of pyramidal or bowel-bladder function score in EDSS during 12 month treatment
[Time Frame: up to 360 days]
|
|
Secondary Outcome(s)
|
|
Change in immunology function
[Time Frame: up to 360 days]
|
|
Secondary ID(s)
|
|
MRCTA,ECFAHOFFMU[2019]142
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|