Clinical Study of TC-V in Patients with Chronic GVHD

Not Applicable

• Conditions: Chronic GVHD after hematopoietic stem cell transplantation

• Registration Number: JPRN-UMIN000014634
• Lead Sponsor: Vorpal Technologies K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-28
• Study Completion: 2016-06-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified