Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT04731103
Eligibility Criteria:
Inclusion Criteria:
* Patients with mutations in any of TREX1, the three components of the RNase H2 complex (RNASEH2A, RNASEH2B, RNASEH2C: considered as one genotype) or SAMHD1.
* Greater than age 3 months and less than 16 years of age at the time of recruitment
* Resident in the United Kingdom (UK)
* Informed Consent obtained from parent or personal legal representative
* For inclusion in the study, a patient has either to have completed the vaccination programme two weeks prior to starting the trial, or remain unvaccinated until the end of the trial, or agree to defer vaccination until immediately after a study drug arm, so that there is a period of at least two weeks following vaccination and before the start of the following drug arm.
Exclusion Criteria:
* Patients with AGS due to mutations in ADAR1 and IFIH1 will not be considered, given that the induction of interferon relating to these genotypes does not involve a reverse transcription step.
* Pre-existing disease, not due to AGS, which would preclude the use of zidovudine, lamivudine and abacavir
* Patients with abnormally low neutrophil counts (\<0.75 x 109/l) and / or abnormally low haemoglobin levels (\<7.5 g/dl)(particularly relevant to zidovudine), significant renal (creatinine clearance \< 50 ml/min; particularly relevant to lamivudine) or significant hepatic impairment (particularly relevant to abacavir; avoid if Child Pugh \> 5)
* Participation in another Clinical Trial of an Investigational Medicinal Product (CTIMP) trial
* Pregnancy
* Breast feeding
* Hepatitis B and C infection
* Potential hypersensitivity to abacavir, assessed according to HLA-B\*5701 status
* Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 of the Summary of Product Characteristics (SPC)
* Where, in the opinion of the Investigator the participant cannot fulfil the requirements of the trial protocol
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Maximum Age:
15 Years
Study:
NCT04731103
Study Brief:
Protocol Section:
NCT04731103