Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation (Valgan)
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| ClinicalTrials.gov Identifier: NCT00227370 |
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Recruitment Status :
Completed
First Posted : September 28, 2005
Results First Posted : April 29, 2013
Last Update Posted : April 29, 2013
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Sponsor:
Scott Palmer
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Scott Palmer, Duke University
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cytomegalovirus Infections | Drug: valganciclovir Other: Placebo | Phase 3 |
A multi-center two phase, double-blind, placebo controlled, randomized prospective study of 130 lung transplant recipients. Patients will be screened and consented prior to transplant. All consented patients will receive IV ganciclovir within 24 hours of transplant for not more than 14 days. Patients will enroll in Phase I of the study is an open label safety and efficacy analysis of three months of oral valganciclovir in adult transplant recipients who are at risk for CMV. After completion of 3 months of open label therapy, patients that meet the criteria for Phase II of the study will be randomized to 9 months of blinded therapy (Placebo/Valgan). Phase II of the study is designed to assess the efficacy of short course sequential IV ganciclovir followed by oral valganciclovir as compared to the extended period of oral valganciclovir prophylaxis in the prevention of CMV disease in at risk lung transplant recipients
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 136 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | A Phase III, Randomized, Double-Blind Comparison of Oral Valganciclovir and Placebo for Prevention of CMV After Lung Transplantation |
| Study Start Date : | July 2003 |
| Actual Primary Completion Date : | April 2008 |
| Actual Study Completion Date : | December 2008 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Valganciclovir 900 mg QD for 9 months post lung transplant.
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Drug: valganciclovir
valgan 900mg QD x 9 months post lung transplant
Other Name: valcyte |
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Placebo Comparator: 2
placebo for 9 months post lung transplant
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Other: Placebo |
Primary Outcome Measures :
- Incidence of CMV End Organ Disease [ Time Frame: over the course of 300 days after randomization ]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.
- Incidence of CMV Syndrome [ Time Frame: over the course of 300 days after randomization ]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)
Secondary Outcome Measures :
- Any CMV Infection [ Time Frame: over the course of 300 days post randomization ]Inclusive of CMV syndrome, disease, or infection not meeting primary end point.
- Biopsy Proven Acute Lung Rejection [ Time Frame: over the course of 300 days of randomization ]
- Non-CMV Infection [ Time Frame: over the course of 300 days after randomization ]non cmv opportunistic infections
- Severity of Viremia [ Time Frame: over the course of 300 days after randomization ]upon diagnosis of cmv disease, the number of CMV DNA copies/mL as measured by PCR
- Ganciclovir Resistance [ Time Frame: over the course of 300 days post randomization ]UL97 genotyping was done on all positive samples for CMV DNA at 1000 copies/mL, with resistance defined by the presence of 1 or more mutations shown by marker transfer to confer phenotypic ganciclovir resistance
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria for Phase I:
- 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
Exclusion Criteria for Phase 1:
- 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
Inclusion Criteria for Phase II:
- Negative serial post transplant PCRs at day 75
- Negative bronchial cultures for CMV
- Adequate hematological and renal function at day 75
- IV ganciclovir for up to 2 weeks post operation and open label up to day 90
- Effective contraceptives
- Negative pregnancy
Exclusion Criteria Phase II:
- Renal failure
- Serious adverse events (SAE) related to study drug
- CMV disease (study endpoint)
- Withdraw consent for Phase II
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227370
Locations
| United States, North Carolina | |
| DukeUMC | |
| Durham, North Carolina, United States, 27710 | |
Sponsors and Collaborators
Scott Palmer
Roche Pharma AG
Investigators
| Principal Investigator: | Scott M Palmer, MD | Duke University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Scott Palmer, Associate Professor of Medicine-Pulmonary, Duke University |
| ClinicalTrials.gov Identifier: | NCT00227370 History of Changes |
| Other Study ID Numbers: |
Pro00013245 4623 (Val038) ( Other Identifier: Alternative study ID ) |
| First Posted: | September 28, 2005 Key Record Dates |
| Results First Posted: | April 29, 2013 |
| Last Update Posted: | April 29, 2013 |
| Last Verified: | April 2013 |
Keywords provided by Scott Palmer, Duke University:
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Acute rejection Non-CMV infections Resistance |
Additional relevant MeSH terms:
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Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases |
Valganciclovir Ganciclovir Antiviral Agents Anti-Infective Agents |