E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Upper respiratory tract infection (as identified by regular surveillance of stem cell transplant patients) or stem cell transplant patients diagnosed as positive for respiratory syncytial virus (RSV). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061603 |
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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 |
Pilot segment: a preliminary assessment of exposure to and safety of oral A-60444 in post-stem cell transplant patients with RSV infection.
Main study: To determine the antiviral effect of oral A-60444 versus placebo in post-stem cell transplant patients with RSV infection;·
To assess the safety of oral A-60444 in post-stem cell transplant patients with RSV infection. |
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E.2.2 | Secondary objectives of the trial |
To study the pharmacokinetics of A-60444 in the presence of concomitant medications such as immunosuppressants and anti-fungals, in post-stem cell transplant patients with RSV infection. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Patients diagnosed with RSV infection who have had a stem cell transplant. 2. Female patients must be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant. Females of non-childbearing potential are defined as women who have had a hysterectomy, bilateral oophorectomy, tubal ligation or who have been post-menopausal for at least two years, or are considered to be sterile due to recent chemotherapy. 3. Aged between 18 and 65 years. 4. Patients who have given their written informed consent to participate in the study. 5. Patients who are willing and able to comply with the protocol and study procedures.
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E.4 | Principal exclusion criteria |
1. Patients who have received an investigational drug within one month preceding the start of dosing. 2. Patients who have a documented history of allergy to benzodiazepines. 3. Patients with significant hepatic impairment (alanine transaminase (ALT) > 5 x upper level of normal (ULN), total bilirubin > 3 x ULN). Biochemistry data collected less than or equal to four weeks prior to screening is acceptable. 4. Patients, who in the opinion of their general practitioner or the Investigator, should not participate in the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of viral load at 72 hours after initial dose.
The primary efficacy measure will be reduction in nasopharyngeal RSV viral load of 2-log as measured by quantitative real time reverse transcription PCR (rtRT-PCR).
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
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Last patient, last visit. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |