A phase 2a single arm study to evaluate the effect of TCN -202 (human anti-cytomegalovirus monoclonal antibody) on CMV infection in CMV (cytomegalovirus) seronegative recipients of kidney allografts from CMV seropositive donors

Theraclone Sciences, Inc0 个研究点开始时间: 2012年11月6日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Patients who are males or females aged 18 to 65 years, inclusive;Patients who are single-organ recipients (kidney only) and CMV seronegative and receiving a kidney transplant from a CMV seropositive (cadaver or living) donor;Females must not be pregnant or nursing and must either be of non-childbearing potential or must agree to use 2 acceptable methods of birth control and must agree to continue doing so for four months after the last dose of TCN-202;Females of childbearing potential and males with female partners with childbearing potential must agree to use effective contraception and must agree to continue doing so for four months after TCN-202 dosing;Adequate venous access and able to receive intravenous infusion;Patients must be able to understand the purpose and risks of the study and sign the informed consent form (ICF).

•Patients who require anti-lymphocyte preparations for induction therapy (indication in the rejection of transplanted organs) or those who receive a kidney with a cold ischemia time higher than 30 hours;patients presenting any acute medical condition or significant past medical history or any condition that in the opinion of the Principal Investigator (PI) or the Sponsor would complicate or compromise the study, or the well-being of the patient;Patients with known positivity to Hepatitis B, Hepatitis C and HIV (1 and 2);Patients with history of cancer (except for non-melanoma skin cancer) within 2 years prior to transplantation;patients with history of drug or alcohol abuse within 6 months prior to transplantation;patients who have received an investigational product in any clinical trial within 12 months of transplantation;patients who have received prior treatment with a monoclonal antibody;Patients who require concomitant treatment with other investigational drugs.

发起方