NCT00214240

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

July 26, 2012

Status Verified

July 1, 2012

Enrollment Period

7.3 years

First QC Date

September 13, 2005

Last Update Submit

July 25, 2012

Conditions

Cytomegalovirus

Outcome Measures

Primary Outcomes (1)

  • CMV viral load

    12 months

Study Arms (2)

1

EXPERIMENTAL

Cytogam in addition to standard of care (IV ganciclovir therapy)

Drug: CMV Immune globulin

2

NO INTERVENTION

Receive standard of care therapy (IV ganciclovir)

Interventions

CMV Immune globulinDRUG

CMV IvIg 150mg/kg x 6 doses

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Renal or renal/pancreas transplant patients who are diagnosed with symptomatic CMV infection
  • receiving no more than 48 hrs of therapy prior to study enrollment

You may not qualify if:

  • serum creatinine \<2.2 at the time of enrollment
  • no prior use of CMV IgG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

cytomegalovirus-specific hyperimmune globulin

Study Officials

  • John Pirsch, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

January 1, 2000

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

July 26, 2012

Record last verified: 2012-07

Locations

US(1)