| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Patients with a first episode of positive CMV-PCR (DNAemia) or pp65 antigenemia assay (antigenemia) up to 100 days after allogeneic SCT. |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 12.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10011831 |
| E.1.2 | Term | Cytomegalovirus infection |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
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. |
|
| E.2.2 | Secondary objectives of the trial |
| 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). |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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. |
|
| E.4 | Principal 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 <50 kg or >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. |
|
| E.5 End points |
| E.5.1 | 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. |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | Yes |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 15 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 25 |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
After completion of the study, the patient will be transferred to routine therapy. The
investigator takes responsibility for decisions about the subsequent treatment. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 6 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 6 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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