UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019942 |
|---|---|
| Receipt number | R000023026 |
| Scientific Title | Long-term study of KW-0761 in patients with HAM |
| Date of disclosure of the study information | 2015/11/26 |
| Last modified on | 2023/08/21 10:31:24 |
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Basic information
Public title
Long-term study of KW-0761 in
patients with HAM
Acronym
0761HAM-L
Scientific Title
Long-term study of KW-0761 in
patients with HAM
Scientific Title:Acronym
0761HAM-L
Region
| Japan |
Condition
Condition
HTLV-1-Associated-Myelopathy Tropical Spastic Paraparesis (HAM/TSP)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the long-term safety and efficacy of KW-0761 in patients with HAM/TSP.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Safety:
Presence or absence and nature of any
adverse effects
Key secondary outcomes
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.)
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
KW-0761 IV administration
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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
Key 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
Target sample size
19
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Yamano M.D.,Ph.D. |
Organization
St. Marianna University School of Medicine Hospital
Division name
Department of Neurology
Zip code
216-8512
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japan
TEL
044-977-8111
yyamano@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Ohta |
Organization
St. Marianna University School of Medicine
Division name
St. Marianna University School of Medicine, Center for Clinical & Translational Science
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
mariadc0761ham1@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine Hospital
Institute
Department
Personal name
Funding Source
Organization
The Research on Measures for Intractable Diseases Project of Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University Group Institutional Review Board
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
044-977-8111
chikenjimu@marianna-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
2015/11/2, 9回
Institutions
Institutions
聖マリアンナ医科大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 26 | Day |
Related information
URL releasing protocol
https://doi.org/10.1093/brain/awad139
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1093/brain/awad139
Number of participants that the trial has enrolled
18
Results
https://doi.org/10.1093/brain/awad139
Results date posted
| 2023 | Year | 08 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
https://doi.org/10.1093/brain/awad139
Participant flow
https://doi.org/10.1093/brain/awad139
Adverse events
https://doi.org/10.1093/brain/awad139
Outcome measures
https://doi.org/10.1093/brain/awad139
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 09 | Month | 24 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
| 2021 | Year | 11 | Month | 12 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 26 | Day |
Last modified on
| 2023 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023026
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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