CLINICAL TRIALS PROFILE FOR CYTOGAM

All Clinical Trials for CYTOGAM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00203281 ↗	Study to Evaluate the Amount of Medications That May be Removed From the Body During Plasmapheresis	Withdrawn	Sidney Kimmel Cancer Center at Thomas Jefferson University		2003-02-01	Based on the limited amount of experience with plasmapheresis and CytoGam concomitant use, the researchers seek to evaluate the pharmacokinetics (drug absorption, distribution, and elimination) of this therapy. The researchers are also interested in evaluating the pharmacokinetics of the various immunosuppressant medications that patients will receive such as tacrolimus, mycophenolate mofetil and daclizumab.
NCT00214240 ↗	The Impact of Cytogam® on Time to Viral Load Reduction in Kidney or Kidney/Pancreas Transplant Recipients With Clinical CMV Disease	Completed	University of Wisconsin, Madison	N/A	2000-01-01	This pilot study is to assess whether using CytoGam® in combination with ganciclovir is more effective in reducing the CMV viral load over time, as compared to standard treatment with IV ganciclovir only. Serial blood samples are drawn to measure the amount of CMV viral load weekly, while the subject is receiving treatment with ganciclovir, or ganciclovir + CytoGam®. Additional CMV viral load blood sampling (CMV DNA capture qualitative testing only) will occur weekly thereafter until the subject is 8 weeks from the time of CMV diagnosis or until the CMV infection is no longer detectable, whichever is longer duration.
NCT00275509 ↗	Induction Therapy Study in Live Donor Kidney Transplant Recipients With a Positive Crossmatch	Completed	Johns Hopkins University	Phase 3	2007-01-01	The purpose of this study is to determine whether the anti-T cell antibody, Thymoglobulin is a more effective induction medication than the anti-IL-2R inhibitor daclizumab, in kidney transplant recipients who have a positive crossmatch with their live donor.
NCT00586716 ↗	Intravenous Immune Globulin (IVIG) Treatment Protocol in Kidney Transplant Patients	Terminated	Loma Linda University	N/A	2004-11-01	The purpose of this study is to test the clinical and laboratory observations of IVIG therapy in the highly sensitized patient. We will study the effects of patients treated with IVIG or Cytogam in combination with plasmaphoresis to modulate the immune response in highly sensitized patients. The goal is to convert a positive crossmatch to a compatible crossmatch that would allow living related transplant to take place or to shorten time on the transplant waiting list.
NCT00784979 ↗	Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation	Completed	CSL Behring	Phase 4	2002-01-01	The purpose of this study is to offer Panel Reactive Antibodies [PRA] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. PRA reduction is offered in the following phases: 1. Immunological Testing 2. Transplant Nephrectomy 3. Pharmacologic Therapy 4. Plasmapheresis 5. Transplant
NCT00784979 ↗	Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation	Completed	Tampa General Hospital	Phase 4	2002-01-01	The purpose of this study is to offer Panel Reactive Antibodies [PRA] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. PRA reduction is offered in the following phases: 1. Immunological Testing 2. Transplant Nephrectomy 3. Pharmacologic Therapy 4. Plasmapheresis 5. Transplant
NCT01376778 ↗	A Randomized Trial to Prevent Congenital Cytomegalovirus (CMV)	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3	2012-04-01	Cytomegalovirus (CMV) is a common virus that usually presents with few if any side effects. When first infected, some people may have symptoms similar to mononucleosis (i.e., fatigue, weakness, fever, swollen glands). Most people in the United States are infected during childhood or as adults if they work around children. Pregnant women, who have not been infected with CMV in the past and become infected during pregnancy (i.e. a primary infection), may cause their babies to get infected with CMV. Babies that are infected may develop permanent disabilities including hearing loss and a small portion will die from the infection. Currently it is not routine practice to screen pregnant women for CMV infection. Additionally, there is no agreement about how to evaluate and manage pregnant women infected with CMV for the first time. There is also no evidence that treatment is beneficial for the baby. The purpose of this research study is to determine whether treating pregnant women who have a primary CMV infection with CMV antibodies will reduce the number of babies infected with CMV.

Clinical Trial Conditions for CYTOGAM

Condition Name

Condition Name for CYTOGAM
Intervention	Trials
End Stage Renal Disease	2
Plasmapheresis	1
Congenital Cytomegalovirus Infection	1
Cytomegalovirus	1

Condition MeSH

Condition MeSH for CYTOGAM
Intervention	Trials
Kidney Failure, Chronic	3
Cytomegalovirus Infections	2
Infections	1
Infection	1

Clinical Trial Locations for CYTOGAM

Trials by Country

Trials by Country for CYTOGAM
Location	Trials
United States	17

Trials by US State

Trials by US State for CYTOGAM
Location	Trials
Pennsylvania	2
New York	2
Colorado	1
California	1
Alabama	1

Clinical Trial Progress for CYTOGAM

Clinical Trial Phase

Clinical Trial Phase for CYTOGAM
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
N/A	2

Clinical Trial Status

Clinical Trial Status for CYTOGAM
Clinical Trial Phase	Trials
Completed	5
Terminated	1
Withdrawn	1

Clinical Trial Sponsors for CYTOGAM

Sponsor Name

Sponsor Name for CYTOGAM
Sponsor	Trials
CSL Behring	2
University of Wisconsin, Madison	1
Johns Hopkins University	1

Sponsor Type

Sponsor Type for CYTOGAM
Sponsor	Trials
Other	7
Industry	2
NIH	1