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Recruitment status Completed
Unique ID issued by UMIN UMIN000014634
Receipt No. R000016971
Official scientific title of the study Clinical Study of TC-V in Patients with Chronic GVHD
Date of disclosure of the study information 2014/07/28
Last modified on 2016/11/18

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Basic information
Official scientific title of the study Clinical Study of TC-V in Patients with Chronic GVHD
Title of the study (Brief title) Clinical Study of TC-V in Patients with Chronic GVHD
Region
Japan

Condition
Condition Chronic GVHD after hematopoietic stem cell transplantation
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of conducting ECP therapy using TC-V in patients with chronic GVHD
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To evaluate based on the changes the organ score and the changes in steroid level at prior to ECP therapy and that at Week 24 of ECP therapy.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type Interventional

Study design
Basic design Single arm
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
Device,equipment
Interventions/Control_1 ECP therapy
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who were diagnosed with chronic GVHD according to GVHD guideline after the transplantation of hematopoietic stem cell derived from related donor or unrelated donor.
2. Patients who are judged to be steroid-resistant, steroid-dependent, or steroid-intolerant.
3. Patients who received an explanation for clinical study and submitted a written informed consent.
Key exclusion criteria 1. Patients who are allergic or hypersensitive to methoxsalen.
2. Patients who cannot tolerate the changes in blood flow associated with ECP therapy.
3. Patients who are hypersensitive or allergic to both heparin and Acid Citrate Dextrose Solution (ACD) (Patients who are hypersensitive or allergic only one of them are not excluded).
4. Patients who are pregnant, patients who have possibility of being pregnant, or patients who are breastfeeding.
5. Patients who cannot use appropriate contraceptive method throughout the study period.
6. Patients who are infected with human immunodeficiency virus (HIV) or active hepatitis B.
7. Patients with diseases associated with aphakia or photosensitivity (such as systemic lupus erythematosus, porphyria, and albinism) (Non-sighted patients with aphakia are not excluded).
8. Patients who are enrolled in other clinical studies not including a treatment outcome study.
9. Patients with previous experience with ECP therapy.
10. Patients with infectious disease which requires treatment.
11. Patients in whom the blood vessel access is difficult.
12. Patients whose kidney function was worsened within past three months (showing serum creatinine concentration of over 3.0 mg/dL).
13. Patients with life expectancy of less than 6 months.
14. Patients in whom the white blood cell count and platelet count are significantly decreased (white blood cell count of less than 1000/micro L and platelet count of less than 25000/micro L).
15. Patients with Karnofsky Performance Scale of less than 30.
16. Patients with active bleeding in gastrointestinal tract (GI bleeding).
17. Patients who received new drug or increased dose of drug within 14 days for the therapy to treat GVHD.
18. Patients in whom the control of primary disease is difficult.
19. Other patients who are judged by physician as being unsuitable.
Target sample size 10

Research contact person
Name of lead principal investigator Okamoto, Shinichiro
Organization Keio University Hospital
Division name Hematology
Address 35 Shinano-machi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email okamoto@a7.keio.jp

Public contact
Name of contact person Kohama, Ichiro
Organization Vorpal Technologies K.K.
Division name Regulatory Research Development & Quality Managemant
Address 4-15-1 Akasaka, Minato-ku, Tokyo
TEL 03-5544-8340
Homepage URL
Email kohama@vorpaltechnologies.com

Sponsor
Institute Vorpal Technologies K.K.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Vorpal Technologies K.K.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 慶應義塾大学病院(東京都)/ Keio University Hospital (Tokyo)
名古屋第一赤十字病院(名古屋)/ Japanese Red Cross Nagoya Daiichi Hospital (Nagoya)
北海道大学病院(北海道)/ Hokkaido University Hospital (Hokkaido)

Other administrative information
Date of disclosure of the study information
2014 Year 07 Month 28 Day

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 04 Month 07 Day
Anticipated trial start date
2014 Year 07 Month 28 Day
Last follow-up date
2016 Year 06 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 07 Month 24 Day
Last modified on
2016 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016971


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