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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003280-11 | EudraCT Number |
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This clinical study will evaluate the safety and tolerability of combination treatment of nintedanib and pirfenidone in participants with IPF. Eligible participants must have received pirfenidone for at least 16 weeks on a stable dose. Nintedanib will be added on Day 1 of the study as a combination treatment for IPF for 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pirfenidone+Nintedanib | Experimental | Participants with IPF will receive pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug | Participants with IPF will receive nintedanib at the 200-300 mg/day dose up to 24 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Complete 24 Weeks of Combination Treatment on Pirfenidone at a Dose of 1602-2403 mg/Day and Nintedanib at a Dose of 200-300 mg/Day | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events and Serious Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Geffen School of Medicine at UCLA;Division of Pulmonary & Critical Care/ Department of Medic | Los Angeles | California | 90095-1690 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29946005 | Derived | Flaherty KR, Fell CD, Huggins JT, Nunes H, Sussman R, Valenzuela C, Petzinger U, Stauffer JL, Gilberg F, Bengus M, Wijsenbeek M. Safety of nintedanib added to pirfenidone treatment for idiopathic pulmonary fibrosis. Eur Respir J. 2018 Aug 2;52(2):1800230. doi: 10.1183/13993003.00230-2018. Print 2018 Aug. |
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At the start of screening, participants were on pirfenidone for at least 16 weeks and on a stable dose (1602-2403 mg/d) for at least 28 days. A total of 109 participants were screened, 20 participants were screen failures and 89 were enrolled at 36 study centers in 8 countries.
Participants with idiopathic pulmonary fibrosis were recruited for this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pirfenidone+Nintedanib | Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 17, 2017 | May 16, 2018 |
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| Pirfenidone | Drug | Participants with IPF will receive pirfenidone at 1602-2403 mg/day dose up to 24 weeks. |
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| Baseline up to Week 28 |
| Percentage of Participants Who Discontinue Pirfenidone, Nintedanib, or Both Study Treatments Because of Adverse Events Before the Week 24 Visit | Baseline up to Week 24 |
| Total Number of Participant Days of Combination Treatment With Pirfenidone and Nintedanib | Baseline up to Week 24 |
| Total Number of Days From the Initiation of Combination Treatment to Discontinuation of Pirfenidone, Nintedanib, or Both Study Treatments | Baseline up to Week 24 |
| Stanford University School of Medicine ; Pulmonary/Critical Care Medicine | Stanford | California | 94305 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109-0666 | United States |
| Cardio-Pulmonary Associates of St. Luke's Hospital | Chesterfield | Missouri | 63017 | United States |
| Creighton University | Omaha | Nebraska | 68131 | United States |
| Atlantic Respiratory Institute | Summit | New Jersey | 07901 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Pulmonix LLC | Greensboro | North Carolina | 27403 | United States |
| UC Health Clinical Trials Office | Cincinnati | Ohio | 45267 | United States |
| John A. Butler, M.D. - Oregon Pulmonary Associates | Portland | Oregon | 97225 | United States |
| Medical University of South Carolina (MUSC); MUSC Pulmonary | Charleston | South Carolina | 29425 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Inova Health Care Services; Advanced Lung Disease Transplant Program | Falls Church | Virginia | 22042 | United States |
| South Health Campus/Alberta Health Services/ University of Calgary | Calgary | Alberta | T3M 1M4 | Canada |
| University Health Network | Toronto | Ontario | M5G 2N2 | Canada |
| Gentofte Hospital, Lungemedicinsk Afdeling | Hellerup | 2900 | Denmark |
| Hopital Avicenne; Pneumologie | Bobigny | 93000 | France |
| Hopital Louis Pradel; Pneumologie | Bron | 69677 | France |
| Hopital de Pontchaillou; Service de Pneumologie | Rennes | 35033 | France |
| Fachkrankenhaus Coswig GmbH Zentrum f.Pneumologie Beatmungsmedizin Thorax-u.Gefäßchirurgie | Coswig | 01640 | Germany |
| Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie | Essen | 45239 | Germany |
| Klinikum Fulda gAG; Universitätsmedizin Marburg, Campus Fulda | Fulda | 36043 | Germany |
| ASST DI MONZA; U O Clinica Pneumologica | Monza | Lombardy | 20900 | Italy |
| A.O. Universitaria San Luigi Gonzaga di Orbassano; Malattie Apparato Respiratorio (MAR2) | Orbassano | Piedmont | 10043 | Italy |
| Azienda Ospedaliero Universitaria Pisana; U.O. Pneumologia | Pisa | Tuscany | 56124 | Italy |
| A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare | Siena | Tuscany | 53100 | Italy |
| Antonius Ziekenhuis; Dept of Lung Diseases | Nieuwegein | 3435 CM | Netherlands |
| Erasmus MC; Afdeling Longziekten | Rotterdam | 3000 CA | Netherlands |
| Hospital Universitari de Bellvitge ; Servicio de Neumologia | L'Hospitalet de Llobregat | Barcelona | 08097 | Spain |
| Hospital del Henares; Medicina Interna. Unidad de Neumología | Coslada (Madrid) | Madrid | 28822 | Spain |
| Hospital Universitario de Canarias; Servicio de Neumologia | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Complejo Asistencial Universitario de Leon; Pneumology | León | 24071 | Spain |
| Hospital Universitario La Princesa; Servicio de Neumologia | Madrid | 28006 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Neumologia | Seville | 41013 | Spain |
| Hospital General Universitario De Valencia; Servicio de Neumologia | Valencia | 46014 | Spain |
| COMPLETED |
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| NOT COMPLETED |
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Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pirfenidone+Nintedanib | Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Who Complete 24 Weeks of Combination Treatment on Pirfenidone at a Dose of 1602-2403 mg/Day and Nintedanib at a Dose of 200-300 mg/Day | Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 24 |
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| Secondary | Percentage of Participants With Adverse Events and Serious Adverse Events | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. | Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1. | Posted | Number | Percentage of Participants | Baseline up to Week 28 |
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| Secondary | Percentage of Participants Who Discontinue Pirfenidone, Nintedanib, or Both Study Treatments Because of Adverse Events Before the Week 24 Visit | Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1. | Posted | Number | 95% Confidence Interval | Percentage of Praticipants | Baseline up to Week 24 |
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| Secondary | Total Number of Participant Days of Combination Treatment With Pirfenidone and Nintedanib | Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1. | Posted | Number | Participant Days | Baseline up to Week 24 |
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| Secondary | Total Number of Days From the Initiation of Combination Treatment to Discontinuation of Pirfenidone, Nintedanib, or Both Study Treatments | Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1. | Posted | Mean | Standard Deviation | Number of Days | Baseline up to Week 24 |
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Baseline up to Week 28
Safety population included all participants who had received at least one dose of investigational medicinal product on or after Day 1.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pirfenidone+Nintedanib | Participants with idiopathic pulmonary fibrosis (IPF) received pirfenidone at 1602-2403 milligrams per day (mg/day) dose and nintedanib at the 200-300 mg/day dose up to 24 weeks. | 0 | 89 | 16 | 89 | 83 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Pneumomediastinum | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Cholecystitis infective | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Tracheobronchitis | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.0 | Non-systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA 20.0 | Non-systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Transient ischaemic attack | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Non-cardiac chest pain | General disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.0 | Non-systematic Assessment |
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| Weight decreased | Investigations | MedDRA 20.0 | Non-systematic Assessment |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jun 21, 2016 | May 16, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C530716 | nintedanib |
| C093844 | pirfenidone |
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| Unknown or Not Reported |
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| Asian |
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| Asian/White |
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| Title | Denominators | Categories | ||||
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