E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Congenital CMV infection after primary CMV infection during pregnancy |
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E.1.1.1 | Medical condition in easily understood language |
Congenital CMV infection after primary CMV infection during pregnancy |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010420 |
E.1.2 | Term | Congenital CMV infection |
E.1.2 | System Organ Class | 100000004850 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Prevention of congenital CMV infection in infants of mothers with primary CMV infection during pregnancy. The number (percentage) of newborns/foetuses with congenital CMV infection is defined as the primary efficacy paramter. |
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E.2.2 | Secondary objectives of the trial |
As most important secondary efficacy endpoints CMV specific IgG serum concentration in maternal blood, ultrasound abnormalities of the foetus and CMV-related clinical symptoms in the infant will be evaluated. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Pregnant women, pregnancy after in-vitro fertilisation permitted
- CMV-specific IgG seronegative pregnant women at screening
- 18 to 45 years of age
- Consent to carrying out a histopathological analysis of foetal brain, liver and kidney biopsy specimen in case of pregnancy termination or spontaneous abortion after confirmed seroconversion during pregnancy
- Written informed consent |
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E.4 | Principal exclusion criteria |
- women with current multiple pregnancy
- women who are planning a home birth
- known immunodeficiency (e.g. congenital agammaglobulinaemia or hypo-gamma-globulinaemia, common variable immunodeficiency, severe combined immuno-deficiencies, Wiskott Aldrich syndrome) or immunosuppression (e.g. renal transplanted patients)
- known hepatitis B or C infections
- known intolerance to proteins of human origin
- known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction)
- Known hypersensitivity to homologous immunoglobulins, especially very rare cases of IgA deficiency, when the patient has antibodies against IgA
- known HIV infection
- Known pre-existing risk factors for thrombotic events (e.g. history of vascular disease or thrombotic episodes, women with acquired or inherited thrombophilic disorders, severely hypovolemic women or women with diseases which increase blood viscosity)
- Known renal insufficiency
- Known hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed
- Participation in another clinical trial within 90 days before entering the study or during the study and/or previous participation in this study during the same pregnancy
- Inability or lack of motivation to participate in the study
- Pregnant women who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study
- Not willing or able to provide written informed consent to participation in the study after being informed by the investigator about the aim, course and possible risks of the study
- Not willing to give consent to transmission of personal “pseudonymised” data to the competent authorities
- Women who are dependant on study site staff, on Biotest AG or its authorised representatives
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of CMV infected newborns/foetuses at birth from seroconverted mothers as confirmed by CMV-DNA using PCR in urinanalysis within 7 days after birth or (additionally) CMV-DNA using PCR of amniotic fluid. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Mother: CMV IgG serum level (recombinant blot with avidity / anti-HCMV rec. gB IgG ELISA)
Foetus: ultrasound abnormalities (EFSUMB level II/III)
Newborn: CMV-related clinical symptoms (feature/number/severity of abnormalities and clinically relevant laboratory findings)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.3 | Therapy | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
standard of care (no treatment) |
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E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 150 |
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 | 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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The end of the trial is defined as the last visit of the last infant of 2 years undergoing the trial. |
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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 | 7 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |