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

NCT ID: NCT01509404

Last Updated: 2018-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-12-31

Brief 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.

Conditions

Cytomegalovirus Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Valcyte

valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant

Group Type: ACTIVE_COMPARATOR

Valganciclovir

Intervention Type: DRUG

Valcyte per package insert guidelines for 200 days post transplant

Valcyte then Cytogam

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 for prophylaxis against CMV infection

Group Type: ACTIVE_COMPARATOR

CMV hyperimmune globulin

Intervention Type: BIOLOGICAL

100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

Valganciclovir

Intervention Type: DRUG

valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant

Interventions

Valganciclovir

Valcyte per package insert guidelines for 200 days post transplant

Intervention Type: DRUG

CMV hyperimmune globulin

100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant

Intervention Type: BIOLOGICAL

Valganciclovir

valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant

Intervention Type: DRUG

Other Intervention Names

Valcyte; Cytogam; Valcyte

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

References

Vernooij RW, Michael M, Colombijn JM, Owers DS, Webster AC, Strippoli GF, Hodson EM. Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2025 Jan 14;1(1):CD005133. doi: 10.1002/14651858.CD005133.pub4.

Reference Type: DERIVED

PMID: 39807668 (View on PubMed)

Other Identifiers

Pro00009601

Identifier Type: -

Identifier Source: org_study_id