Valganciclovir in Prevention of Cytomegalovirus (CMV) Reactivation Following Allogeneic-Stem Cell Transplantation (SCT)
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|ClinicalTrials.gov Identifier: NCT00330018|
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : April 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Bone Marrow Transplantation Cytomegalovirus||Drug: Valganciclovir Drug: Acyclovir||Phase 3|
Cytomegalovirus (CMV), the most common viral infection following stem cell transplantation (SCT), causes significant morbidity and mortality. It can result in CMV pneumonitis, hepatitis, encephalitis and gastrointestinal disease, as well as fever and neutropenia. Furthermore, CMV has been shown to be associated with a number of indirect effects in SCT recipients including reduced long-term patient survival, increased risks of opportunistic infections, allograft dysfunction, acute and chronic graft vs. host disease (GVHD). SCT patients at highest risk are seronegative donors, matched unrelated donors, SCT with T-cell depletion, patients after cord blood SCT, and patients with GVHD.
Valganciclovir, a valine ester pro-drug of ganciclovir, was developed to overcome the limitations of oral and i.v. ganciclovir, with a single once-daily 900 mg oral dose providing comparable plasma ganciclovir exposures to those achieved with 5 mg/kg i.v. ganciclovir. Its bioavailability is up to 10-fold higher than that of oral ganciclovir (same as above). There is already extensive clinical experience with valganciclovir in AIDS patients, where it has proved as effective as i.v. ganciclovir in treating newly diagnosed CMV retinitis, and in patients after solid organ transplant but no comparative data exists in patients after SCT.
We therefore planned a prospective, randomized study to evaluate the efficacy and safety of valganciclovir compared with acyclovir for prevention of CMV disease in SCT recipients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Investigator Initiated Prospective Randomized, Controlled Pilot Study in Order to Evaluate the Place of Valganciclovir in Prevention of Cytomegalovirus Reactivation Following Allogeneic Stem Cell Transplantation|
|Study Start Date :||February 2006|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Active Comparator: 2
- Prevention of CMV reactivation [ Time Frame: 100d ]
- Occurrence of CMV disease [ Time Frame: 6m ]
- Overall survival [ Time Frame: 6m ]
- Occurrence of GVHD [ Time Frame: 6m ]
- Occurrence of other infections [ Time Frame: 6m ]
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): NCT00330018
|Hadassah Medical Organization,|
|Jerusalem, Israel, 91120|
|Principal Investigator:||Michael Y Shapira, MD||Hadassah Medical Organization|