A study to determine the safety and efficacy of the experimental medicine T-Guard for treating acute Graft-versus-Host Disease that does not sufficiently improve with the standard steroid treatment
- Conditions
- Acute Graft-versus-Host Disease (GVHD) not responding on regular first line therapy of 2 mg/kg corticosteroids daily.MedDRA version: 17.0Level: LLTClassification code 10068908Term: AGVHDSystem Organ Class: 100000004870Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2013-000068-27-DE
- Lead Sponsor
- Xenikos BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
- Patients suffering from acute GVHD which is staged as Grade II-IV (Appendix 1) according to the modified Glucksberg Criteria and progressing after 3 days, or not improving after 7 days, of methylprednisolone at a dose of 2 mg/kg per day.
- Age = 18 years.
- Patients or an impartial witness (in case the patient is capable to provide verbal consent but not capable to sign the informed consent) should have given written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 16
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4
- Patients receiving concomitant investigational therapeutics for acute GVHD, including investigational agents used for GVHD prophylaxis, at the time of enrollment.
- Patients with signs or symptoms suggestive of chronic GVHD.
- Patients requiring mechanical ventilation, requiring vasopressor support, requiring hemodialysis, having serum creatinine > 266 µmol/l (> 3mg/dl), or having a serum albumin level of 15 g/l or less.
- Patients having uncontrolled infections.
- Patients with current signs or symptoms of active intrapulmonary disease.
- Patients with known hypersensitivity to any of the components of the study drug (murine mAb or RTA).
- Female patients who are pregnant, breast feeding, or, if sexually active, unwilling to use effective birth control for the duration of the study.
- Male patients who are, if sexually active, unwilling to use effective birth control for 30 days after the last infusion.
- Patients participating in a clinical trial with another investigational medicinal product within 30 days prior to providing informed consent.
- Patients whose decision to participate might be unduly influenced by perceived expectation of gain or harm by participation, such as patients in detention due to official or legal order.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method