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

NCT01509404 | Completed Phase 4 Results

• 1 other identifier: Pro00009601
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

CMV; cytomegalovirus; transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of Patients With Early CMV Infection

  100 days

• Number of Patients With Cell Mediated Immunity

  2 years

• Renal Function

  6, 12, and 24 months after transplant

• Number of Participants With Acute Cellular and/or Antibody Mediated Rejection

  2 years

• Number of Participants With Opportunistic Infections

  2 years

Study Arms (2)

Valcyte

ACTIVE COMPARATOR

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

Drug: Valganciclovir

Valcyte then Cytogam

ACTIVE COMPARATOR

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

Biological: CMV hyperimmune globulin; Drug: Valganciclovir

Interventions

CMV hyperimmune globulin BIOLOGICAL

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

Also known as: Cytogam

Valcyte then Cytogam

Valganciclovir DRUG

Valcyte per package insert guidelines for 200 days post transplant

Also known as: Valcyte

Valcyte

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients ≥ 18 years of age.
• Male or female patients who CMV seronegative receiving a kidney, pancreas or liver from a seropositive donor.
• The patient has given written informed consent to participate in the study.

You may not qualify if:

• Solid organ transplant recipient is CMV seropositive at the time of transplant.
• Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).
• Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.
• Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.
• Patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, CMV hyperimmune globulin, basiliximab or corticosteroids.
• Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.
• 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.
• 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.
• Inability to cooperate or communicate with the investigator.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• CSL Behring: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 39807668 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valganciclovir; cytomegalovirus-specific hyperimmune globulin

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Ganciclovir; Acyclovir; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: James Fleming
• Organization: Medical University of South Carolina

fleminj@musc.edu

843-792-0312

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2012
• First Posted: January 13, 2012
• Study Start: November 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: October 4, 2018
• Results First Posted: October 4, 2018

Record last verified: 2018-09

Locations

US (1)