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Generated: December 16, 2018

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CLINICAL TRIALS PROFILE FOR VALCYTE

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Clinical Trials for Valcyte

Trial ID Title Status Sponsor Phase Summary
NCT00090766 A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients Completed Hoffmann-La Roche Phase 2/Phase 3 This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals.
NCT00092222 Virotherapy and Natural History Study of KHSV-Associated Multricentric Castleman s Disease With Correlates of Disease Activity Recruiting National Cancer Institute (NCI) Phase 2 This study will gain information about a rare disorder called KSHV-associated multicentric Castleman s disease (MCD). KSHV, a virus, causes several kinds of cancer, including some forms of MCD. KSHV stands for the Kaposi s sarcoma herpes virus, also called human herpes virus-8, or HHV-8. Researchers want to understand the biology of KSHV-MCD to identify how this disease causes illness and to find ways to treat it. There is no standard therapy effective for all cases of KSHV-MCD. The disease is often fatal, and about half the people who have it die within 2 years of diagnosis. Patients ages 12 and older may be eligible for this study. Participation entails more drawing of blood and having repeated tumor biopsies than if patients received treatment in a non-research setting. Researchers would like to learn more about the relationship of KSHV and Castleman s disease symptoms, and they want to obtain at least three biopsies in this study. There are some side effects of experimental therapy that patients may take for KSHV-MCD. Zidovudine, or Retrovir , is used at a high dose. It is given orally or through a vein, four times daily, for 7 days or longer. Zidovudine can cause nausea, vomiting, decreased bone marrow function, and decreased blood counts. Combined with valganciclovir, or Valcyte , it is likely to be more toxic to bone marrow. Valganciclovir can cause problems with bone marrow function, leading to low blood counts, sterility, and defects in a fetus. Combined with zidovudine, valganciclovir may cause more toxicity to the bone marrow. It is given twice daily for 7 days or longer. Bortezomib, or Velcade , is given for a few seconds by a rapid push through a needle into the vein. It is given twice weekly for four doses and then stopped for 1 week. Bortezomib can sometimes cause low blood pressure; it also can cause gastrointestinal problems and a low blood platelet count. Rituximab and liposomal doxorubicin are drugs given by a catheter into a vein. Interferon-alpha is given by injection into the skin. Those drugs are not experimental, but their use in Castleman s disease is experimental. Some patients may be treated with a combination of chemotherapy followed by interferon-alpha. Interferon-alpha is infected into the skin by a needle. The natural form of interferon is produced by the body and helps to control viral infections. KSHV decreases the effect of the body s interferon, and the researchers want to see if giving higher doses of interferon will help to control KSHV infection. A positron emission tomography (PET) scan, for research purposes only, may be done up to three times a year. A radioactive sugar molecule called fluorodeoxyglucose, or FDG, is used. It is believed that activated lymphocytes that may be found in patients disease might use more FDG because these cells burn more glucose fuel. Children younger than 18 years will not have PET scan done. This study may or may not have a direct benefit for participants. However, detailed assessments made throughout the study may provide information to help the doctors treat KSHV-MCD better.
NCT00141037 Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation Completed Astellas Pharma Inc Phase 1/Phase 2 Over the last 40 years, corticosteroids (steroids) have been an important part of drug regimens used to prevent organ rejection and to maintain the immune health of individuals who have received organ transplants. Unfortunately, the negative physical effects of steroids can be severe, especially in children. The purpose of this study is to determine the safety and effectiveness of a steroid-free treatment regimen for children and adolescents who have received kidney (renal) transplants.
NCT00141037 Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation Completed Hoffmann-La Roche Phase 1/Phase 2 Over the last 40 years, corticosteroids (steroids) have been an important part of drug regimens used to prevent organ rejection and to maintain the immune health of individuals who have received organ transplants. Unfortunately, the negative physical effects of steroids can be severe, especially in children. The purpose of this study is to determine the safety and effectiveness of a steroid-free treatment regimen for children and adolescents who have received kidney (renal) transplants.
NCT00141037 Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 1/Phase 2 Over the last 40 years, corticosteroids (steroids) have been an important part of drug regimens used to prevent organ rejection and to maintain the immune health of individuals who have received organ transplants. Unfortunately, the negative physical effects of steroids can be severe, especially in children. The purpose of this study is to determine the safety and effectiveness of a steroid-free treatment regimen for children and adolescents who have received kidney (renal) transplants.
NCT00194467 Suppression of Oral HHV8 Shedding With Valganciclovir Completed Hoffmann-La Roche Phase 2 The purpose of the study is to use valganciclovir to define the role of antiviral therapy in suppression of HHV-8 shedding in HHV-8 seropositive men. Our hypothesis is that valganciclovir will substantially reduce the frequency of detection and amount of HHV-8 in the mouth.
NCT00194467 Suppression of Oral HHV8 Shedding With Valganciclovir Completed University of Washington Phase 2 The purpose of the study is to use valganciclovir to define the role of antiviral therapy in suppression of HHV-8 shedding in HHV-8 seropositive men. Our hypothesis is that valganciclovir will substantially reduce the frequency of detection and amount of HHV-8 in the mouth.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Valcyte

Condition Name

Condition Name for Valcyte
Intervention Trials
Cytomegalovirus Infections 8
Chronic Lymphocytic Leukemia 4
Sensorineural Hearing Loss 3
Cytomegalovirus Infection 3
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Condition MeSH

Condition MeSH for Valcyte
Intervention Trials
Cytomegalovirus Infections 19
Leukemia 5
Leukemia, Lymphoid 5
Leukemia, Lymphocytic, Chronic, B-Cell 5
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Clinical Trial Locations for Valcyte

Trials by Country

Trials by Country for Valcyte
Location Trials
United States 90
Canada 9
Spain 7
Australia 6
Mexico 5
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Trials by US State

Trials by US State for Valcyte
Location Trials
California 10
Pennsylvania 6
Texas 6
New York 5
Minnesota 5
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Clinical Trial Progress for Valcyte

Clinical Trial Phase

Clinical Trial Phase for Valcyte
Clinical Trial Phase Trials
Phase 4 8
Phase 3 9
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Valcyte
Clinical Trial Phase Trials
Completed 20
Recruiting 9
Unknown status 3
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Clinical Trial Sponsors for Valcyte

Sponsor Name

Sponsor Name for Valcyte
Sponsor Trials
Hoffmann-La Roche 11
Roche Pharma AG 4
M.D. Anderson Cancer Center 3
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Sponsor Type

Sponsor Type for Valcyte
Sponsor Trials
Other 30
Industry 25
NIH 6
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