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Eine Studie zu Vismodegib (orale Verabreichung) in Kombination mit Pirfenidon bei Teilnehmenden mit idiopathischer Lungenfibrose
A Study of Oral Vismodegib in Combination With Pirfenidone in Participants With Idiopathic Pulmonary Fibrosis (ISLAND2)
- Atemwegserkrankungen
- Idiopathische Lungenfibrose
Bitte beachten Sie, dass der Rekrutierungsstatus der Studie an Ihrem Standort vom Gesamtstatus der Studie abweichen kann, da einige Studienzentren früher rekrutieren als andere.
Status der Studie:
Abgeschlossen
Diese Studie läuft in
Stadt
- Hannover
Studien-ID:
NCT02648048 2015-003481-81 GB29764
Studienzusammenfassung
This is a single arm, multicenter, open-label, Phase 1b study to evaluate the safety and tolerability of vismodegib in combination with pirfenidone in participants with idiopathic pulmonary fibrosis (IPF) currently being treated with pirfenidone.
Hoffmann-La Roche
Sponsor
Phase 1
Phase
NCT02648048,GB29764,2015-003481-81
Studien-ID
Pirfenidone, Vismodegib
Treatments
Idiopathic Pulmonary Fibrosis
Condition
Official Title
A Single Arm, Multicenter, Open-label, Phase 1b Study to Assess the Safety and Tolerability of Oral Vismodegib in Combination With Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Einschlusskriterien
All
Gender
≥ 40 Years & ≤ 80 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Have a diagnosis of IPF 5 years from time of screening, confirmed at baseline
- Tolerated dose of pirfenidone 1602-2403 mg once daily (QD) for a minimum of 24 weeks required prior to and during screening
- Greater than or equal to (>=) 50 percent (%) and less than or equal to (<=) 100% of predicted forced vital capacity (FVC) at screening
- Stable baseline lung function as evidenced by a difference of less than (<) 10% in absolute FVC measurements (in liters) between screening and Day 1/Visit 2 prior to enrollment
- >=30% and <=90% of predicted diffusion capacity of the lung for carbon monoxide at screening
- Agree to use protocol defined methods of contraception
- Male participants must agree not to donate semen during the study and for at least 2 months (or as per local requirements) after the last dose of vismodegib
- Agree not to donate blood or blood products during the study and for at least 9 months (or as per local requirements) after the last dose of study treatment
Exclusion Criteria
- Prior treatment with vismodegib or any Hh-pathway inhibitor
- Evidence of other known causes of interstitial lung disease
- Hospitalization due to an exacerbation of IPF within 4 weeks prior to or during screening
- Lung transplant expected within 6 months of screening
- Evidence of clinically significant lung disease other than IPF
- Post-bronchodilator forced expiratory volume in 1 second/FVC ratio <0.7 at screening
- Any clinically significant medical disease (other than IPF) that is associated with an expected survival of <6 months, likely to require a change in therapy during the study
- Class IV New York Heart Association chronic heart failure or historical evidence of left ventricular ejection fraction <35%
- Known current malignancy or current evaluation for a potential malignancy
- Known immunodeficiency, including, but not limited to, human immunodeficiency virus infection
- Evidence of acute or chronic hepatitis or known liver cirrhosis
- Creatinine clearance <=30 milliliter per minute, calculated using the Cockcroft-Gault formula
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