Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation

NCT00227370 | Completed Phase 3 Results

• 2 other identifiers: Pro000132454623 (Val038)
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The study evaluated the efficacy and safety of a prolonged, continuous course of Valganciclovir (Valgan) in the prevention of CMV by comparing 3 months of Vaglanciclovir, the standard of care upon initiation of the study, to 12 months of Valganciclovir.

Conditions

Cytomegalovirus Infections

Keywords

Acute rejection; Non-CMV infections; Resistance

Outcome Measures

Primary Outcomes (2)

• Incidence of CMV End Organ Disease

  The primary study end point was CMV end-organ disease determined by positive tissue immunostain or characteristic histopathology assessed for within 300 days post randomization.

  over the course of 300 days after randomization

• Incidence of CMV Syndrome

  CMV clinical syndrome, with either positive serum PCR or positive culture for CMV from bronchoalveolar lavage and at least 2 of the following: fever, leukopenia, thrombocytopenia, elevated liver function test results malaise, reduction in pulmonary function (FEV1) greater than 20percent of baseline, or radiographic infiltrate consistent with CMV (all in the absence of other causes)

  over the course of 300 days after randomization

Secondary Outcomes (5)

• Any CMV Infection

  over the course of 300 days post randomization

• Biopsy Proven Acute Lung Rejection

  over the course of 300 days of randomization

• Non-CMV Infection

  over the course of 300 days after randomization

• Severity of Viremia

  over the course of 300 days after randomization

• Ganciclovir Resistance

  over the course of 300 days post randomization

Study Arms (2)

1

ACTIVE COMPARATOR

Valganciclovir 900 mg QD for 9 months post lung transplant.

Drug: valganciclovir

2

PLACEBO COMPARATOR

placebo for 9 months post lung transplant

Other: Placebo

Interventions

valganciclovir DRUG

valgan 900mg QD x 9 months post lung transplant

Also known as: valcyte

1

Placebo OTHER

2

Eligibility Criteria

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

You may qualify if:

• Adult lung transplant recipients age 18 or older
• At risk for CMV (donor or recipient serology must be positive for CMV)
• Adequate hematological and renal function,
• On intravenous (IV) ganciclovir within 24 hours of surgery
• Agreement to use effective methods of contraception
• Negative pregnancy
• Tolerate oral medications within 2 weeks of transplant
• Negative baseline CMV PCR
• Able to understand and sign the informed consent

You may not qualify if:

• Repeat transplantation
• Mechanical ventilation at study entry
• Oral or intravenous ganciclovir treatment outside the study protocol
• Invasive fungal infection
• Participation in another investigational study
• Acute CMV infection or disease
• Anti-CMV therapy within 30 days before enrollment
• Uncontrolled diarrhea or malabsorption
• Allergic reaction to study drug
• Required use of prohibited medications
• Lactating women
• Pregnancy
• Renal failure
• Negative serial post transplant PCRs at day 75
• Negative bronchial cultures for CMV

Sponsors & Collaborators

• Duke University: lead
• Roche Pharma AG: collaborator

Study Sites (1)

DukeUMC

Durham, North Carolina, 27710, United States

Location

Related Publications (3)

• 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

• Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.

  PMID: 38700045 DERIVED

• Palmer SM, Limaye AP, Banks M, Gallup D, Chapman J, Lawrence EC, Dunitz J, Milstone A, Reynolds J, Yung GL, Chan KM, Aris R, Garrity E, Valentine V, McCall J, Chow SC, Davis RD, Avery R. Extended valganciclovir prophylaxis to prevent cytomegalovirus after lung transplantation: a randomized, controlled trial. Ann Intern Med. 2010 Jun 15;152(12):761-9. doi: 10.7326/0003-4819-152-12-201006150-00003.

  PMID: 20547904 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

Valganciclovir

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: Scott M. Palmer, MD, MHS
• Organization: Duke Clinical Research Institute

scott.palmer@duke.edu

919 684 0254

Study Officials

• Scott M Palmer, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 28, 2005
• Study Start: July 1, 2003
• Primary Completion: April 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 4, 2024
• Results First Posted: April 29, 2013

Record last verified: 2024-09

Locations

US (1)