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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019942
Receipt No. 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 2016/03/17

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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:
- Patients with radically resected solid tumor which have not recurred within the five years preceding enrollment
- Patients with 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
Middle name
Last name Yoshihisa Yamano M.D.,Ph.D.
Organization St. Marianna University School of Medicine Hospital
Division name Department of Neurology
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8512 Japan
TEL 044-977-8111
Email yyamano@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eriko Aotani, RN, MSN, CCRP
Organization 0761HAM Coordinating Center
Division name Kanagawa Academy of Science and Technology Global Health Research Coordinating Center
Zip code
Address KSP EAST 3F. 3-2-1 SAKADO. TAKATSU-KU. KAWASAKI-SHI. KANAGAWA 213-0012. JAPAN
TEL 044-850-1731
Homepage URL
Email ham-japan@newkast.or.jp

Sponsor
Institute St. Marianna University School of Medicine Hospital
Institute
Department

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
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 30 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 26 Day
Last modified on
2016 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023026

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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