Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection

Cytomegalovirus Disease Clinical Trial

Official title:

Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for CMV Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01509404
• Other study ID #: Pro00009601
• Status: Completed
• Phase: Phase 4
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: September 2018
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male and female patients = 18 years of age.

2. Male or female patients who CMV seronegative receiving a kidney, pancreas or liver from a seropositive donor.

3. Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to receiving transplant or study inclusion.

4. The patient has given written informed consent to participate in the study.

Exclusion Criteria:

1. Solid organ transplant recipient is CMV seropositive at the time of transplant.

2. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).

3. Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.

4. Patients with thrombocytopenia (<25,000/mm3 ), with an absolute neutrophil count of < 1,000/mm3); and/or leucopoenia (< 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.

5. Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.

6. Patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, CMV hyperimmune globulin, basiliximab or corticosteroids.

7. Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.

8. Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.

9. Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.

10. Inability to cooperate or communicate with the investigator.

Related Conditions & MeSH terms

• Cytomegalovirus Disease
• Cytomegalovirus Infections

Intervention

Drug:
• Valganciclovir
Valcyte per package insert guidelines for 200 days post transplant

Biological:
• CMV hyperimmune globulin
100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

Drug:
• Valganciclovir
valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	CSL Behring

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Late CMV Disease	Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant	after 200 days post-transplant until 2 years post-transplant
Secondary	Number of Patients With Early CMV Infection		100 days
Secondary	Number of Patients With Cell Mediated Immunity	Positive CMV quantiferon at last follow-up	2 years
Secondary	Renal Function	Renal function will be assessed by an estimated creatinine clearance utilizing the abbreviated Modification of Diet in Renal Disease (MDRD) equation at 6, 12, and 24 months after transplant	6, 12, and 24 months after transplant
Secondary	Number of Participants With Acute Cellular and/or Antibody Mediated Rejection		2 years
Secondary	Number of Participants With Opportunistic Infections		2 years
Secondary	Number of Participants With Asymptomatic CMV Viremia		2 years
Secondary	Number of Participants With CMV Seroconversions		2 years