Completed
Ganciclovir for Serious or Life-Threatening Cytomegalovirus Infections
What is being tested
Ganciclovir
Drug
Who is being recruted
Blood-Borne Infections+26
+ Urogenital Diseases
+ Genital Diseases
Over 18 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Summary
Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
This study focuses on a medication called ganciclovir, which is given to patients with weakened immune systems who are battling serious cytomegalovirus (CMV) infections. The goal is to provide this treatment to those in need, while also understanding its safety and effectiveness in this specific patient group. Cytomegalovirus infections can be severe in individuals with compromised immunity, making this research crucial for improving their care and addressing this significant health challenge.
Principal SponsorHoffmann-La Roche
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesAmino Acid Metabolism, Inborn ErrorsCommunicable DiseasesDNA Virus InfectionsHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesOpportunistic InfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsMitochondrial DiseasesGenetic Diseases, InbornAcquired Immunodeficiency SyndromeCytomegalovirus InfectionsHIV InfectionsAIDS-Related Opportunistic InfectionsMultiple Acyl Coenzyme A Dehydrogenase Deficiency
Criteria
2 inclusion criteria required to participate
Patients must be immunocompromised with a serious cytomegalovirus (CMV) infection. This would include pneumonia, gastrointestinal disease, hepatitis, or other organ-specific disease or severe wasting syndrome
Patients with pre-existing neutropenia or thrombocytopenia, and immediate life-threatening disease can be included if the investigator believes that delay in starting ganciclovir therapy is not advisable. In such patients, the investigator must advise the patient of the risk of further marrow suppression and the increased risk of infection or bleeding; and the patient must sign an amended informed consent form
6 exclusion criteria prevent from participating
Congenital or neonatal CMV infections where there is not documented congenital or acquired immunodeficiency
Mild to moderate cytomegalovirus (CMV) infections that fail to satisfy the clinical severity criteria
Neutropenia unless it is pre-existing
Other myelosuppressive drugs such as cancer chemotherapy agents, interferon, foscarnet, or nucleoside analogs
Show More Criteria
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Roche Global Development - Palo Alto
Palo Alto, United StatesOpen Roche Global Development - Palo Alto in Google MapsCompletedOne Study Center