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dbGaP phs000556 NHLBI GO-ESP: Family Studies (Atypical Cystic Fibrosis) - Eligibility

- 2025-01-29 - 6 Formulär, 1 Item-grupp, 2 Dataelement, 1 Språk

Item-grupp: IG.elig

Principal Investigator: Garry R. Cutting, MD, Johns Hopkins Medical Institutes, McKusick-Nathans Institute of Genetic Medicine, Baltimore, MD, USA MeSH: Cystic Fibrosis https://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000556 The NHLBI "Grand Opportunity" Exome Sequencing Project (GO-ESP), a signature project of the NHLBI Recovery Act investment, was designed to identify genetic variants in coding regions (exons) of the human genome (the "exome") that are associated with heart, lung and blood diseases. These and related diseases that are of high impact to public health and individuals from diverse racial and ethnic groups will be studied. These data may help researchers understand the causes of disease, contributing to better ways to prevent, diagnose, and treat diseases, as well as determine whether to tailor prevention and treatments to specific populations. This could lead to more effective treatments and reduce the likelihood of side effects. GO-ESP is comprised of five collaborative components: 3 cohort consortia - HeartGO, LungGO, and WHISP - and 2 sequencing centers - BroadGO and SeattleGO. Cystic fibrosis (CF) patients without detectable disease-causing mutations in CFTR present a clinical phenotype very similar to, but possibly discrete from, classic CF. We hypothesize that the phenotype of these atypical CF patients is not due only to mutations in the carbonic anhydrase gene CA12 or in the genes encoding the epithelium sodium ion channel ENaC, but is due to mutations in novel genes that have yet to be associated with CF. The goal of this study is to determine the molecular etiology of this atypical CF.

Cystic Fibrosis

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Sputum collection

- 2021-09-27 - 1 Formulär, 7 Item-grupper, 24 Dataelement, 1 Språk

Item-grupper: Administrative data, Dosing date and time, Sputum induction, Sputum sample quality, Sputum sample preparation and hemacytometry, Sample collection summary, Sputum slide results

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Sputum collection form. It has to be filled in for V2b, V5 and if requiered for logs/ repeats. This document can be filled in as often as necessary for logs/ repeats.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Logs and Repeats

- 2021-09-27 - 1 Formulär, 4 Item-grupper, 16 Dataelement, 1 Språk

Item-grupper: Administrative Data, Date of visit/assessment, AE/Concomitant medication/Repeat an assessment check question, Liver event

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Logs and Repeats form.

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit 1-8

- 2021-09-20 - 1 Formulär, 10 Item-grupper, 72 Dataelement, 2 Språk

Item-grupper: Outpatient Department, Disease, vital signs; lung function, Clinical status, Antibiotics, Azithromycin, therapy, antibiotics, inhaled, Antibiotics, Specimen Collection, Dispatch

Study documentation part: Outpatient Department Visit 1 - 8. Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Dissection of Staphylococcus Aureus Infection From Colonization in Cystic Fibrosis Patients (StaphCI) NCT00669760- Outpatient Department Visit (Undefined)

- 2021-09-20 - 4 Formulär, 10 Item-grupper, 72 Dataelement, 2 Språk

Item-grupper: Outpatient Department, Disease, vital signs; lung function, Clinical status, Antibiotics, Azithromycin, therapy, antibiotics, inhaled, Antibiotics, Specimen Collection, Dispatch

Study documentation part: Outpatient Department Visit (Undefined and with microbiology part). Dissection of staphylococcus aureus infection from colonization in cystic fibrosis patients, a non-interventional, prospective, longitudinal multicenter study. Trial number: NCT00669760.

Microbiology- Staphylococcus aureus characteristics

5 Item-grupper 29 Dataelement

Microbiology- Sputum, Serum and EDTA blood

3 Item-grupper 13 Dataelement

Eligibility NCT00506688 Cystic Fibrosis - Eligibility

- 2021-09-20 - 1 Formulär, 2 Item-grupper, 20 Dataelement, 2 Språk

Item-grupper: Inclusion Criteria, Exclusion Criteria

ODM derived from http://clinicaltrials.gov/show/NCT00506688

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Subject Diary Card

- 2020-03-05 - 1 Formulär, 8 Item-grupper, 41 Dataelement, 1 Språk

Item-grupper: Administrative data, Emergency, Diary card, Study drug, Exacerbations, Other medications, Changes in health, Daily Respiratory Symptom Diary for Cystic Fibrosis

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Subject Diary Card form. It has to be filled in at day 2-13, day 15-20 and day 22-27.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Liver events

- 2020-03-05 - 1 Formulär, 9 Item-grupper, 42 Dataelement, 1 Språk

Item-grupper: Administrative data, Liver event, Investigational product (Liver), Pharmacokinetics (Liver PK), Liver disease medical conditions, Drug related liver disease conditions, Other liver disease conditions, Other medical conditions, Alcohol intake

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the liver events form. It has to be filled in if a liver event occurs during the study.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - 12-Lead ECG Abnormalities

- 2020-03-04 - 1 Formulär, 8 Item-grupper, 92 Dataelement, 1 Språk

Item-grupper: Administrative data, 12 Lead ECG abnormalities, Rhythm, P-Wave and QRS Morphology, Conduction, Myocardial Infarction, Depolarisation/Repolarisation (QRS-T), Other abnormalities

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the ECG Abnormalities form. Fill in if there is a clinical significant ECG Abnormality.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Concomitant medication

- 2020-03-04 - 1 Formulär, 2 Item-grupper, 18 Dataelement, 1 Språk

Item-grupper: Administrative Data, Concomitant Medication

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the concomitant medication form. It has to be filled in if concomitant medication has been taken by subject during the study.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Laboratory data

- 2020-03-04 - 1 Formulär, 4 Item-grupper, 12 Dataelement, 1 Språk

Item-grupper: Administrative Data, Haematology, Clinical chemistry, Urinalysis

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the electronically transferred lab data form. It has to be filled in for screening,V2a, V3, V5, follow-up and if required for logs/ repeats. This document can be filled in as often as necessary for logs/ repeats.

Safety, tolerability and pharmacodynamics of Elubrixin in cystic fibrosis patients, NCT00903201 - Cystic fibrosis exacerbations

- 2020-03-02 - 1 Formulär, 2 Item-grupper, 8 Dataelement, 1 Språk

Item-grupper: Administrative Data, Cystic fibrosis exacerbations

Study ID: 110399 Clinical Study ID: 110399 Study Title: A randomized, double blind, parallel group, placebo controlled 28 day study to investigate the safety, tolerability and pharmacodynamics of SB-656933 in subjects with cystic fibrosis. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00903201 https://clinicaltrials.gov/ct2/show/NCT00903201?term=NCT00903201 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 2 Study Recruitment Status: Completed Generic Name: SB656933, Placebo Trade Name: N/A Study Indication: Cystic Fibrosis The study consists of a screening, five study visits and a follow-up (time relative to Baseline in days): Visit 1: Screening, Day -28 to -16 Visit 2a: Day -7 to -4 Visit 2b: Day 1 Visit 3: Day 14 Visit 4: Day 21 Visit 5: Day 28 Visit 6: Early Withdrawal/ Follow-up, Day 35 to 42. From day 1 to day 28 the patients will receive daily doses. This document contains the Cystic fibrosis exacerbations form. It has to be filled in if the subject has a cystic fibrosis exacerbation during the study.

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dbGaP phs000556 NHLBI GO-ESP: Family Studies (Atypical Cystic Fibrosis) - Eligibility

pht003136.v1.p1

pht003137.v1.p1

pht003138.v1.p1

pht003139.v1.p1

pht003140.v1.p1