Who is sponsoring NCT00655343?

NCT00655343 is sponsored by Neovii Biotech.

What condition does NCT00655343 study?

NCT00655343 studies Graft vs Host Disease.

What drugs are being tested in NCT00655343?

Interventions: ATG-Fresenius S.

What is the status of NCT00655343?

NCT00655343 is currently COMPLETED.

Last reviewed 2011-12-09 · How we verify

GvHD Prophylaxis With ATG-Fresenius S in Allogeneic Stem Cell Transplantation From Matched Unrelated Donors: A Randomized Phase III Multicenter Trial Comparing a Standard GvHD Prophylaxis With Cyclosporine A and Methotrexate With Additional Pretransplant ATG-Fresenius S

NCT00655343 Phase 3 COMPLETED

The study aim is to evaluate the influence of the anti-T-lymphocyte globulin ATG-Fresenius S given pre-transplant in addition to standard GvHD prophylaxis with cyclosporine A and a short course of methotrexate with respect to efficacy and safety.

Details

Lead sponsor	Neovii Biotech
Phase	Phase 3
Status	COMPLETED
Enrolment	202
Start date	2003-02
Completion	2009-03

Conditions

Graft vs Host Disease

Interventions

ATG-Fresenius S

Primary outcomes

Primary: Early treatment failure defined by the occurrence of severe acute GvHD (°III-°IV) or early mortality within 100 days post transplantation. — 100 days

Countries

Germany