Patients with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after allogeneic SCT. MedDRA version: 12.1 Level: LLT Classification code 10011831 Term: Cytomegalovirus infection
Conditions
Interventions
Trade Name: Valcyte®
Product Name: Valganciclovir
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VALGANCICLOVIR HYDROCHLORIDE
CAS Number: 175865-59-5
Concentration unit: mg milligram(s)
Sponsors
Pierrel Research Europe GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for this study, a patient must have the following documented: 1. Patient following allogeneic SCT, 2. Patient with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after SCT (see Part I Section 5.2.2.1), 3. Ability to take oral drugs, 4. ANC =1000 cells/µL on 2 consecutive follow-ups within 10 days before randomization, 5. Patient has a creatinine clearance of =25 mL/min (calculated by the Cockcroft-Gault formula, see Part I Section 6.1.2) with evidence of improving renal function, 6. None or gastrointestinal GVHD up to grade 2*, 7. Age range: Patient is 18 years of age or older, 8. Patient is willing to participate and to comply with the study, and gives written informed consent to the study as well as data protection procedures, 9. In general, women of childbearing potential should be using highly effective contraception throughout the whole study period and for 90 days following discontinuation of the Study Drug. A highly effective method of birth control is defined as one which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence, or vasectomized partner. Male patient must agree to use condoms throughout the whole study period and for 90 days following discontinuation of the Study Drug, 10. Female patient of childbearing potential must have a negative pregnancy test at Visit 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient with any of the following will not be eligible for participation: 1. Patient has a suspected or diagnosed CMV disease, 2. Patient has received syngeneic SCT, 3. Patient who received an IMP within the last 30 days prior to screening or who is simultaneously participating in another clinical study with an IMP, 4. Patient with a body weight 95 kg, 5. Patient has received anti-CMV therapy within the past 30 days prior to screening (the use of acyclovir, valacyclovir, or famciclovir is permitted), 6. Patient who has participated in this study before, 7. Patient who shows a neutropenia, thrombocytopenia, or anemia within 10 days before or at the time point of randomization as following: - the ANC is <1000 cells/µL on 2 consecutive follow-ups, or - a platelet count of =25000/µL can not be achieved/maintained with platelet transfusions, or - a hemoglobin level of =8g/dL can not be achieved/maintained by red blood cell transfusions, 8. Female patient lactating, pregnant, or of childbearing potential not using a reliable contraceptive method, 9. Patient who is incapable to understand the aim, importance, and consequences of the study and to give legal informed consent, 10. Patient with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study, 11. Patient who possibly is dependent on the sponsor or investigator, 12. Patient has severe, uncontrolled diarrhea (multiple watery stools) or evidence of malabsorption, 13. Patient has exhibited an allergic or other significant adverse reaction to acyclovir, valacyclovir, ganciclovir, or valganciclovir in the past, 14. Patient has AST, ALT and/or total bilirubin levels greater than 5 times ULN, 15. Patient is positive for HIV and/or Hepatitis C, 16. Patient is positive for HBsAg and/or HBV-DNA. Inclusion of patients positive for anti- HBs and/or anti-HBc but negative for HBsAg and/or HBV-DNA is permitted, 17. Patient has a current severe illness or any other condition(s) (e.g. psychiatric disorder) which would make the patient, in the opinion of the investigator, unsuitable for the study, 18. Patient is unlikely to be available for the full duration of the study (12 weeks), 19. Patient received prohibited medication as defined in Part I Section 4.4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to assess the efficacy and safety of oral valganciclovir versus intravenous ganciclovir in patients following allogeneic SCT. - The event-free survival (patients without CMV disease or death from any cause) within 180 days after SCT. - The proportion of patients with severe neutropenia (ANC <500 cells/µL) until 7 days after discontinuation of antiviral therapy with the Study Drug.;Secondary Objective: The secondary obectives of this study are to assess the efficacy and safety of oral valganciclovir versus intravenous ganciclovir in patients following allogeneic SCT, too (please refer to the study protocol).;Primary end point(s): The primary endpoint of this study is a combined endpoint of efficacy and safety. The 2 primary variables are: • The event-free survival (patients without CMV disease or death from any cause) within 180 days after SCT, • The proportion of patients with severe neutropenia (ANC <500 cells/µL) until 7 days after discontinuation of antiviral therapy with the Study Drug. | — |
Countries
Austria, Germany, Spain
Outcome results
None listed