ISRCTN53454974进行中（未招募）未知
Real world clinical outcomes with novel modifier therapy combinations in people with cystic fibrosis
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 206
研究概览
简要总结
2023 Results article in https://doi.org/10.1164/rccm.202308-1317OC (added 20/03/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Inclusion Criteria for Parent Study (UK CTIMP Sites)
- •1. Participants may only be selected for inclusion in RECOVER if they have been independently determined by their treating physician to be suitable for treatment with ETI in compliance with the official marketing authorization and summary of product characteristics (SPC). The decision to include participants in the study is independent of decision to prescribe ETI. Participants will receive treatment only through prescription by their physician through usual clinical treatment pathways.
- •Inclusion Criteria for Subjects on ETI
- •1. In exceptional circumstances where baseline clinical data has been collected prior to the start of treatment either through clinical care or ethically approved research projects (including a cohort of subjects initially recruited to this study on the understanding that it was a non-regulated observational study) subjects already receiving ETI may be recruited to this study and undergo on-treatment visits. Any additional patient data can only be added with written informed consent from the patients/parents concerned.
- •2. All subjects must have a signed informed consent form and/or signed assent form when appropriate, as determined by the subjects age and individual site and country standards.
- •3. Male and female participants of childbearing potential must agree to adhere to contraception requirements as detailed in the local ETI SmPC and in line with the standard of care.
- •Inclusion Criteria for Extension Study (UK CTIMP Sites)
- •1. Children and adults with CF who have completed two years participation on the parent study, and are willing to provide informed consent for continued data and bio-sample collection for a period of five years.
- •Previous inclusion criteria as of 29/04/2021:
- •Inclusion Criteria for RECOVER CTIMP (UK clinical sites only):
- •1. People with CF aged 12 years and over: Participants may only be selected for inclusion in RECOVER if they have been independently determined by their treating physician to be suitable for treatment with Kaftrio in compliance with the official marketing authorization and summary of product characteristics (SPC). The decision to include participants in the study is independent of decision to prescribe Kaftrio. Participants will receive treatment only through prescription by their physician through usual clinical treatment pathways
- •2. Children aged 6-11 years will be included in the study only if and when Kaftrio is licenced, approved and funded for this age group. Participants may only be selected for inclusion in RECOVER if they have been independently determined by their treating physician to be suitable for treatment with Kaftrio in compliance with the official marketing authorization and summary of product characteristics (SPC). The decision to include participants in the study is independent of decision to prescribe Kaftrio. Participants will receive treatment only through prescription by their physician through usual clinical treatment pathways.
- •3. In exceptional circumstances where baseline clinical data has been collected prior to the start of treatment either through clinical care or ethically approved research projects (including a cohort of subjects initially recruited to this study on the understanding that it was a non-regulated observational study) subjects already receiving Kaftrio may be recruited to this study and undergo on-treatment visits. Any additional patient data can only be added with wri
排除标准
- •Current exclusion criteria as of 20/03/2024:
- •Exclusion Criteria for Parent Study (UK CTIMP Sites)
- •1. Patients not willing to comply with study procedures or assessments.
- •2. Individuals on clinical trials of investigational CFTR modulators.
- •3. Clinical instability at baseline assessments. Subjects undergoing an active exacerbation and at the beginning of their treatment should be excluded from the study as this is likely to skew the data.
- •4. Any contraindication to ETI treatment as per the local approved SmPC.
- •5. Severe hepatic impairment.
- •6. Pregnant and breastfeeding women.
- •Exclusion Criteria for Extension Study (UK CTIMP Sites)
- •1. Participants not willing to comply with study procedures or assessments.
- •Previous exclusion criteria as of 29/04/2021:
- •Exclusion Criteria for RECOVER CTIMP (UK clinical sites only):
- •1. Patients not willing to comply with study procedures or assessments
- •2. Individuals on clinical trials of investigational CFTR modulators
- •3. Clinical instability at baseline assessments. Subjects undergoing an active exacerbation and at the beginning of their treatment should be excluded from the study as this is likely to skew the data
- •4. Any contraindication to Katrio treatment as per the local approved SmPC
- •5. Severe hepatic impairment
- •6. Pregnant and breastfeeding women
- •Exclusion Criteria for RECOVER Observational Study (Irish Sites Only):
- •1. Patients not willing to comply with study procedures or assessments. Individuals on clinical trials of investigational CFTR modulators.
- •2. Clinical instability at baseline assessments. Subjects undergoing an active exacerbation and at the beginning of their treatment should be excluded from the study as this is likely to skew the data.
- •Previous exclusion criteria:
- •1. Patients not willing to comply with study procedures or assessments
- •2. Individuals on clinical trials of investigational CFTR modulators.
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