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Valganciclovir

Generic Name
Valganciclovir
Brand Names
Valcyte
Drug Type
Small Molecule
Chemical Formula
C14H22N6O5
CAS Number
175865-60-8
Unique Ingredient Identifier
GCU97FKN3R
Background

Valganciclovir hydrochloride (Valcyte, manufactured by Roche) is an antiviral medication used to treat cytomegalovirus infections. As the L-valyl ester of ganciclovir, it is actually a prodrug for ganciclovir. After oral administration, it is rapidly converted to ganciclovir by intestinal and hepatic esterases.

Indication

Valganciclovir is an antiviral medication used for the treatment of cytomegalovirus infections.

Associated Conditions
Cytomegalovirus (CMV) Infections, Cytomegalovirus Retinitis

A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus

Phase 3
Terminated
Conditions
Cytomegalovirus Disease
Kidney Transplant Infection
Interventions
First Posted Date
2015-05-12
Last Posted Date
2021-07-16
Lead Sponsor
Chimerix
Target Recruit Count
6
Registration Number
NCT02439957
Locations
🇺🇸

Yale New Haven Hospital, New Haven, Connecticut, United States

🇺🇸

University of Colorado Hospital/Health Science Center, Aurora, Colorado, United States

🇺🇸

St. Vincent Medical Center, Los Angeles, California, United States

Cell Mediated Immunity for Secondary Prophylaxis in CMV SOT Patients

Not Applicable
Completed
Conditions
Cytomegalovirus Viraemia
Interventions
First Posted Date
2015-02-25
Last Posted Date
2017-09-21
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
32
Registration Number
NCT02370758
Locations
🇨🇦

University Health Network, Toronto General Hospital, Multi-Organ Transplant, Toronto, Ontario, Canada

Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting Condition

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-11-21
Last Posted Date
2014-11-21
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
83
Registration Number
NCT02297854
Locations
🇮🇳

Lambda Therapeutic Research Ltd, Ahmedabad, Gujrat, India

Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed Condition

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2014-11-20
Last Posted Date
2014-11-20
Lead Sponsor
Dr. Reddy's Laboratories Limited
Target Recruit Count
66
Registration Number
NCT02296723
Locations
🇮🇳

Lambda Therapeutic Research Ltd, Ahmedabad, Gujrat, India

Congenital Cytomegalovirus: Efficacy of Antiviral Treatment

Phase 3
Completed
Conditions
Congenital Cytomegalovirus Infection
Sensorineural Hearing Loss
Interventions
First Posted Date
2013-12-09
Last Posted Date
2021-06-03
Lead Sponsor
Dr. Ann C.T.M. Vossen
Target Recruit Count
37
Registration Number
NCT02005822
Locations
🇳🇱

Department Medical Microbiology, Leiden, Zuid Holland, Netherlands

ValGanciclovir Versus ValAcyclovir for Viral Prophylaxis in Kidney Transplantation

Phase 2
Completed
Conditions
Transplantation Infection
Epstein-Barr Virus Infections
Cytomegalovirus Infections
Interventions
First Posted Date
2013-10-30
Last Posted Date
2022-04-12
Lead Sponsor
University of Minnesota
Target Recruit Count
137
Registration Number
NCT01972035
Locations
🇺🇸

University of MN, Minneapolis, Minnesota, United States

A Study on Spermatogenesis in Male Renal Transplant Recipients Receiving Valganciclovir (Valcyte®) Versus Untreated Matched Controls

Phase 4
Completed
Conditions
Cytomegalovirus Infections
Interventions
First Posted Date
2012-08-13
Last Posted Date
2018-08-31
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
59
Registration Number
NCT01663740
Locations
🇺🇸

Tufts Medical Center, Boston, Massachusetts, United States

🇺🇸

University of Minnesota, Minneapolis, Minnesota, United States

🇺🇸

University of California at San Francisco, San Francisco, California, United States

and more 16 locations

Congenital Cytomegalovirus: Efficacy of Antiviral Treatment in a Randomized Controlled Trial

Phase 3
Terminated
Conditions
Sensorineural Hearing Loss
Congenital Cytomegalovirus Infection
Interventions
First Posted Date
2012-08-01
Last Posted Date
2015-06-18
Lead Sponsor
Dr. Ann C.T.M. Vossen
Target Recruit Count
2
Registration Number
NCT01655212
Locations
🇳🇱

Department Medical Microbiology, Leiden University Medical Center, Leiden, Zuid Holland, Netherlands

Valganciclovir Therapy in Infants and Children With Congenital CMV Infection and Hearing Loss

Phase 2
Completed
Conditions
Cytomegalovirus Infection
Interventions
Other: Placebo
First Posted Date
2012-07-25
Last Posted Date
2024-10-16
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
54
Registration Number
NCT01649869
Locations
🇺🇸

Children's of Alabama Child Health Research Unit (CHRU), Birmingham, Alabama, United States

🇺🇸

University of Rochester Medical Center, Rochester, New York, United States

🇺🇸

Children's National Medical Center - Sheikh Zayed Campus - Infectious Disease, Washington, District of Columbia, United States

and more 15 locations

CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")

Phase 4
Completed
Conditions
Cytomegalovirus Infection
Interventions
First Posted Date
2012-03-13
Last Posted Date
2021-08-26
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
205
Registration Number
NCT01552369
Locations
🇺🇸

Ronald Reagan University of California Los Angeles Medical Center, Los Angeles, California, United States

🇺🇸

Mayo Clinic, Rochester - Infectious Diseases, Rochester, Minnesota, United States

🇺🇸

Emory Clinic - Transplant Center, Atlanta, Georgia, United States

and more 3 locations
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