A study to determine if GBT440 can increase the level of oxygen in the blood of people with Idiopathic Pulmonary Fibrosis (IPF) who need to use supplemental oxygen when resting.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)MedDRA version: 20.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2017-001276-27-GB
- Lead Sponsor
- Global Blood Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 32
1) 45 to 85 years of age inclusive, at randomization
2) Able and willing to provide signed informed consent to participate in
this study
3) Documented diagnosis of IPF, as indicated in the American Thoracic
Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Respiratory Society (ALAT) 2011 Guidelines
4) Receiving supplemental O2 for use at rest.
• Subjects using O2 only with exercise will not be eligible.
5) Resting oxygen saturation (SpO2) between 85 and 88% for at least
30 consecutive seconds while breathing room air (refer to Section 5.1 and Section 5.5.2 for details on confirming eligibility)
Or
Resting SpO2 <85% for 10 consecutive seconds or, if in the opinion of the site staff, it is not safe or tolerable for the subject to continue without using their supplemental oxygen for 10 consecutive seconds whilst the SpO2 is <85%.
Either of these 2 criteria should be met at both screening and Day 1 visits.
6) Able, in the Investigator’s opinion, to walk a total of at least 100 meters at completion of the baseline 6-minute walk test (6MWT)
7) Weight =40 kg
8) Able, in the Investigator’s opinion, to complete the O2 titration study unassisted at baseline (Day 1) and Days 30, 90, and 120
9) Able, in the Investigator’s opinion, to comply with the study procedures, including attending the assessment visits and adhering to study requirements and restrictions
10) Male or female of childbearing potential willing and able to use highly effective methods of contraception from study start to 30 days after the last dose of study drug
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 24
1) Forced expiratory volume in 1 second (FEV1) / forced vital capacity (FVC) <70%
2) History of interstitial lung diseases secondary to other medical conditions (e.g., scleroderma, sarcoidosis, or rheumatoid arthritis) or resulting from clinically significant environmental exposures including but not limited to, drug toxicity, hypersensitivity pneumonitis, or asbestos
3) Hospitalization due to an exacerbation of IPF within 30 days of
screening
4) Documented pulmonary hypertension that is severe (World Health Organization [WHO] Functional Class IV) and/or clinically unstable,
as determined by the study Investigator
• Subjects with documented mild to moderate pulmonary hypertension on a stable regimen of therapy for at least 3 months prior to screening will be eligible for the study
5) Subject plans to begin, or has commenced, pulmonary rehabilitation
within 30 days of screening
• Subject who is on a stable exercise regimen at screening or whose regimen, in the opinion of the Investigator, is not expected to change at any time during the entire study will be considered eligible for the study
6) Corticosteroid therapy for the treatment of IPF, >10 mg per day of
prednisone (or an equivalent), administered for 7 days or longer, within 30 days of screening.
• Subjects receiving a stable dose of =10 mg per day of prednisone (or an equivalent) for at least 14 days prior to screening, and in the opinion of the Investigator not anticipated to require a dose adjustment during the study, are eligible for the study
7) Corticosteroid therapy for treatment of non-IPF diseases, unless:
• Receiving a stable dose of prednisone (or an equivalent) for at least 14 days prior to screening, and in the opinion of the Investigator not anticipated to require a dose adjustment during the study
8) Participated in another clinical trial of an investigational drug (or medical device) within 30 days or 5-half-lives, whichever is longer, prior to screening, or is currently participating in another trial of an investigational drug (or medical device).
9) Aspartate aminotransferase (AST), alanine aminotransferase (ALT)
or total bilirubin >2 × upper limit of normal (ULN)
10) Serum creatinine >2.0 mg/dL
11) Clinical evidence of active infection, within 14 days of screening, which may include but is not limited to bronchitis, pneumonia, urinary tract infection, or cellulitis.
12) Active viral hepatitis within the last 6 months
13) Active tuberculosis within the last 6 months
• Testing for latent tuberculosis is not required
14) Electrocardiogram (ECG) with a corrected QT interval using the Fridericia formula (QTcF) >450 ms (males) or QTcF >470 ms (females)
• If ventricular pacing is noted on ECG, then QTcF intervals will not be calculated
15) Family or personal history of congenital long QT syndrome
16) Female who is breast-feeding or pregnant
17) Known current malignancy or current evaluation for a potential
malignancy or history of malignancy within the past 2 years prior to
screening, except for a
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method