{"type":"trials","record":{"id":56364,"source_id":"clinicaltrials-gov","external_id":"NCT02730208","title":"A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation","brief_summary":"The primary purpose of study is to evaluate the treatment effect of tezacaftor in combination with ivacaftor (TEZ/IVA) on chest imaging endpoints using low-dose computed tomography (LDCT) at Week 72, and to evaluate the safety of TEZ/IVA through Week 72.","overall_status":"Completed","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"Vertex Pharmaceuticals Incorporated","enrollment":41,"countries":["Australia"],"start_date":"2016-09-01","completion_date":"2018-07-01","last_update_date":"2019-10-23","source_url":"https://clinicaltrials.gov/study/NCT02730208","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T02:16:44.048862+00:00","last_seen_at":"2026-09-25T06:15:20.281+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"12 Years","comparator":"Placebo","organization":"Vertex Pharmaceuticals Incorporated","interventions":["Tezacaftor/Ivacaftor","Ivacaftor","Placebo"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Absolute Change in Total Brody/CF-CT Score — From Baseline at Week 72","Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — Day 1 up to Wee…"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","source_has_results":true},"controlled_terms":["Cystic Fibrosis","Tezacaftor/Ivacaftor","Ivacaftor","Placebo"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":50,"publication_state":"published","match_explanation":"Title contains controlled term: fibrosis.","quality_checked_at":"2026-09-25T06:15:30.843286+00:00","duplicate_cluster_key":"id:nct02730208","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2016-09-01 to 2018-07-01","comparator":"Placebo","confidence":"structured-source","population":"ALL · 12 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:15:20.394Z","intervention":["Tezacaftor/Ivacaftor","Ivacaftor","Placebo"],"participants":41,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · TRIPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE2","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Absolute Change in Total Brody/CF-CT Score — From Baseline at Week 72","Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — Day 1 up to Wee…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"extracellular-matrix-aging","is_published":true,"match_reasons":["Title contains controlled term: fibrosis.","Source terminology contains: fibrosis.","Title supplies longevity context: aging.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Extracellular matrix ageing","slug":"extracellular-matrix-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/56364","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}