Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT02846324 |
Date of registration:
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07/07/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study to Evaluate the Safety and Tolerability of GBT440 Administered to Subjects With IPF
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Scientific title:
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A Phase II Randomized, Placebo-Controlled Study of GBT440 to Evaluate the Safety, Tolerability, Pharmacokinetics and Effect on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF) |
Date of first enrolment:
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June 2016 |
Target sample size:
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39 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02846324 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Documented diagnosis of IPF.
- Oxygen desaturation with exercise.
- Completion of the baseline 6MWT
- Weight = 50 kg
- Male or female of child bearing potential willing and able to use highly effective
methods of contraception from study start to 3 months after the last dose of study
drug.
Exclusion Criteria:
- FEV1/FVC < 70%.
- Subjects on supplemental oxygen therapy at rest.
- History of other interstitial lung diseases.
- Significant polycythemia.
- Female who is breast-feeding or pregnant.
- Known current malignancy or history of malignancy within the last 2 years prior to
screening.
- Use of cytotoxic and/or immunosuppressant medications within 30 days screening.
- Hospitalization due to an exacerbation of IPF within 30 days of screening
- Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of
screening
- Corticosteroids (> 10 mg per day of prednisone or an equivalent) within 30 days of
screening.
- Current smoker or history of smoking within 3 months of screening.
- Currently or, in the opinion of the investigator, soon to be listed for lung
transplant.
- History of unstable or deteriorating cardiac or pulmonary disease (other than IPF)
within 6 months of screening.
- Any condition possibly affecting drug absorption.
- 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).
- Subject who, for any reason, is deemed by the investigator to be inappropriate for
this study.
Age minimum:
45 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypoxemia
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Idiopathic Pulmonary Fibrosis
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Intervention(s)
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Drug: Placebo
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Drug: GBT440
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Primary Outcome(s)
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Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.03
[Time Frame: Days 1 to 58]
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Secondary Outcome(s)
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Pharmacokinetic Profile of GBT440 Including Apparent Terminal Half Life
[Time Frame: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only]
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Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry After Exercise
[Time Frame: Baseline to Day 28]
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Pharmacokinetic Profile of GBT440 Including Maximum Concentration
[Time Frame: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only]
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Pharmacokinetic Profile of GBT440 Including Minimum Concentration
[Time Frame: Days 1 and 28: pre-dose, and 2 hours post dose (+/- 15 minutes); Day 2: 24 hours (+/- 2 hours) after the Day 1 dose and prior to receiving the Day 2 dose; Days 8 & 15: pre-dose only]
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Evaluate the Effect of GBT440 on Oxygen Saturation Using Pulse Oximetry at Rest
[Time Frame: Baseline to Day 28]
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Secondary ID(s)
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GBT440-006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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