E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
herpes simplex or varicella zoster virus infections in infants 1 month to <1 year of age |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019948 |
E.1.2 | Term | Herpes simplex |
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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 |
To evaluate the pharmacokinetics of a single dose of famciclovir in infants 1 month to <1 year of age who are at risk of, or who have herpes simplex virus infections. |
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E.2.2 | Secondary objectives of the trial |
• To assess the safety of the single dose of famciclovir; and • To assess tolerability/acceptability of the pediatric formulation.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Male and female patients from 1 month to <1 year of age, regardless of their immune status, who have active, suspected or latent herpes simplex infection, who are at risk of developing herpes simplex virus infections, and who are candidates for antiviral therapy.
2. Patients may be starting or currently using acyclovir. Patients on oral, i.v. or topical antiviral therapy (acyclovir, valacyclovir, ganciclovir) ideally should have a wash-out period of ≥8 hours prior to study drug administration. The investigator will carefully assess the impact of discontinuing standard therapy before enrollment. If the investigator feels that discontinuation of current antiviral is not indicated, then the patient may be enrolled without a washout period. Patients who require episodic antiviral treatment (acyclovir or valacyclovir) should be given their final dose ≥8 hours prior to dosing.
3. Patients expected to survive more than 4 weeks. 4. Patients whose physical examination demonstrates no abnormalities that would make this study medically hazardous to them. 5. Patients with Informed Consent Forms [approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)] signed by the parent/legal guardians 6. Patients whose parent/guardians are able to follow verbal and/or written instructions in the local language.
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E.4 | Principal exclusion criteria |
1. Patients with a gestational age <32 weeks. Patients with a gestational age <35 weeks are excluded from Cohort 1 only. 2. Patients unable to swallow (patients who are unconscious/coma due to encephalitis, patients who have extensive gingivo-stomatitis are excluded only if drinking is impaired) 3. Patients with a history of malabsorption or previous gastrointestinal surgery, or history of radiation therapy that could effect drug absorption or metabolism, or any other disorder or history of a condition that could interfere with drug absorption, distribution, metabolism, or excretion. 4. Patients with a clinically significant abnormality of the hepatic and renal systems. 5. Patients with any of the following age-adjusted clinical or hematological laboratory and blood chemistry abnormalities (Grade 2 abnormalities as defined by ranges of the local laboratory. The following values are given as guidances): ─ AST/SGOT or ALT/SGPT greater than 3x ULN ─ Total bilirubin greater than 2x ULN ─ Serum creatinine greater than 2x ULN ─ Absolute WBC count less than 4000 /mm3 ─ Platelet counts less than 50 000 /mm. ─ Hemoglobin < 7.0 g/dL 6. Patients with a known hypersensitivity to famciclovir or penciclovir or drugs with similar chemical structures. 7. Patients concomitantly using probenecid 8. Patients who sustained a significant blood volume loss (>3% of calculated blood volume) in the past 30 days. 9. Patients who have taken an investigational drug or participated in an investigational study (with the exceptions of protocols studying marketed nucleoside analogues for herpes infections) within 30 days or 5 half-lives (which ever is longer) prior to study drug administration.
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E.5 End points |
E.5.1 | Primary end point(s) |
Pharmacokinetics, safety and tolerability/acceptability |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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 | 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) | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | 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 | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 7 |
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 |
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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
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last visit of the last subject |
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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 | 10 |
E.8.9.1 | In the Member State concerned days | 20 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 20 |