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Generated: March 26, 2019

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CLINICAL TRIALS PROFILE FOR GANCICLOVIR SODIUM

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Clinical Trials for Ganciclovir Sodium

Trial ID Title Status Sponsor Phase Summary
NCT00002034 A Study of the Safety and Tolerance of Long-Term Therapy With Intravenous Cytovene (Ganciclovir Sodium) for Cytomegalovirus Retinitis in Persons With AIDS Completed Hoffmann-La Roche N/A To evaluate the safety and tolerance of long-term ganciclovir (DHPG) therapy for newly diagnosed macular threatening Cytomegalovirus (CMV) retinitis in AIDS patients. To evaluate the clinical response to a 52 week course of intravenous DHPG therapy. To evaluate the safety and tolerance of long-term DHPG with concurrent treatment with zidovudine (AZT). (Patients utilizing treatment with other anti-retroviral drugs will be considered for study entry on a case by case basis.) To determine survival in this group of patients with AIDS and CMV retinitis.
NCT00986557 T-Lymphocyte Infusion or Standard Therapy in Treating Patients at Risk of Cytomegalovirus Infection After a Donor Stem Cell Transplant Unknown status University Hospital Birmingham Phase 2 RATIONALE: An infusion of cytomegalovirus-specific T lymphocytes may prevent or reduce cytomegalovirus infection during the first year after a donor stem cell transplant. PURPOSE: This randomized phase II trial is studying T-lymphocyte infusion to see how well it works compared with standard therapy in treating patients at risk of cytomegalovirus infection after a donor stem cell transplant.
NCT01199562 Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant Completed National Cancer Institute (NCI) N/A RATIONALE: Infection prophylaxis and management may help prevent cytomegalovirus (CMV) infection caused by a stem cell transplant. PURPOSE:This clinical trial studies infection prophylaxis and management in treating cytomegalovirus infection in patients with hematologic malignancies previously treated with donor stem cell transplant.
NCT01199562 Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant Completed City of Hope Medical Center N/A RATIONALE: Infection prophylaxis and management may help prevent cytomegalovirus (CMV) infection caused by a stem cell transplant. PURPOSE:This clinical trial studies infection prophylaxis and management in treating cytomegalovirus infection in patients with hematologic malignancies previously treated with donor stem cell transplant.
NCT01649869 Congenital CMV and Hearing Loss in Children up to 4 Years of Age: Treating With Valganciclovir Therapy Recruiting University of Alabama at Birmingham Phase 2 Valganciclovir is a mono-valyl ester pro-drug of ganciclovir, which is rapidly converted to ganciclovir on absorption. Valganciclovir is approved for the treatment of Cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS), and for the prevention of CMV disease in kidney, heart, and kidney-pancreas high-risk transplant patients. The formulation used in this study will be valganciclovir oral solution which is commercially available. It will be provided as a 12g powder containing 5g valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water. The valganciclovir oral solution formulation does not contain lactose anhydrous. The placebo comparator will be commercially available Simple Syrup (Syrup NF) as 60-90% sucrose in purified water.
NCT03299452 Clinical Studies by Using Accelerated PDX Model to Screen Drugs for Advanced Solid Tumor Recruiting Haining Health-Coming Biotech Co., Ltd. Phase 2 This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS,safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on the accelerated PDX model screening in subjects with advanced malignant tumor.
NCT03586284 Systemic and Topical Antivirals for Control of Cytomegalovirus Anterior Uveitis: Treatment Outcomes Not yet recruiting Francis I. Proctor Foundation Phase 2/Phase 3 Cytomegalovirus (CMV) is generally a latent and asymptomatic infection in healthy, immunocompetent individuals. In immunocompromised patients CMV is well known to cause a retinitis that can lead to blindness. In immunocompetent patients, however, CMV can cause recurrent inflammation in the front of the eye (anterior uveitis). CMV anterior uveitis produces complications including pain, glaucoma, corneal failure, and vision loss. CMV anterior uveitis is commonly misdiagnosed as a non-infectious anterior uveitis and treated as such, which can beget further complications. Diagnosis requires directed polymerase chain reaction (PCR) testing. While antiviral therapy exists for CMV, identifying the appropriate therapy has been challenging because no randomized trials comparing routes of therapy (particularly oral or topical) have been performed. Oral antiviral therapy of CMV carries blood and kidney side effects that requires laboratory monitoring. Topical therapy has been reported to be effective, but no consensus as to the appropriate drug concentration exists. Here we propose a double-masked randomized controlled clinical trial comparing the efficacy of oral valganciclovir, topical ganciclovir 2%, and placebo for the treatment of PCR-proven CMV anterior uveitis. This pilot study will provide valuable information concerning the treatment of CMV anterior uveitis with oral and topical medications, including effective concentrations and side-effect profile. The information obtained from this study will help inform future larger clinical trials in CMV anterior uveitis.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Ganciclovir Sodium

Condition Name

Condition Name for Ganciclovir Sodium
Intervention Trials
Recurrent Adult T-cell Leukemia/Lymphoma 1
Stage I Marginal Zone Lymphoma 1
Stage IV Adult Hodgkin Lymphoma 1
Chronic Neutrophilic Leukemia 1
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Condition MeSH

Condition MeSH for Ganciclovir Sodium
Intervention Trials
Cytomegalovirus Infections 3
Infection 2
Neoplasm Metastasis 2
Leukemia, Prolymphocytic 1
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Clinical Trial Locations for Ganciclovir Sodium

Trials by Country

Trials by Country for Ganciclovir Sodium
Location Trials
United States 17
United Kingdom 6
Canada 1
China 1
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Trials by US State

Trials by US State for Ganciclovir Sodium
Location Trials
New York 2
California 2
Alabama 2
Utah 1
Rhode Island 1
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Clinical Trial Progress for Ganciclovir Sodium

Clinical Trial Phase

Clinical Trial Phase for Ganciclovir Sodium
Clinical Trial Phase Trials
Phase 2/Phase 3 1
Phase 2 3
N/A 2
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Clinical Trial Status

Clinical Trial Status for Ganciclovir Sodium
Clinical Trial Phase Trials
Recruiting 2
Completed 2
Not yet recruiting 1
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Clinical Trial Sponsors for Ganciclovir Sodium

Sponsor Name

Sponsor Name for Ganciclovir Sodium
Sponsor Trials
City of Hope Medical Center 1
King Chulalongkorn Memorial Hospital 1
National Cancer Institute (NCI) 1
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Sponsor Type

Sponsor Type for Ganciclovir Sodium
Sponsor Trials
Other 10
Industry 1
NIH 1
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