Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest (Zephyr)
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ClinicalTrials.gov Identifier: NCT02989168 |
Recruitment Status :
Terminated
(The study was terminated due to lack of clinically meaningful benefit)
First Posted : December 12, 2016
Results First Posted : August 21, 2020
Last Update Posted : August 21, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Idiopathic Pulmonary Fibrosis Hypoxemia | Drug: GBT440 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 14 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Supportive Care |
Official Title: | A Phase II Open Label Study to Evaluate the Effect of GBT440 on Hypoxemia in Subjects With Idiopathic Pulmonary Fibrosis (IPF) Who Are Using Supplemental Oxygen at Rest (ZEPHYR) |
Study Start Date : | November 2016 |
Actual Primary Completion Date : | October 23, 2017 |
Actual Study Completion Date : | October 23, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: GBT440 900 mg Dose
Part A, 900 mg GBT440: Capsules which contain GBT440 drug substance in Swedish orange |
Drug: GBT440
GBT440: Capsules which contain GBT440 drug substance in Swedish orange |
Experimental: GBT440 1500 mg Dose
Part B , 1500 mg GBT440: Capsules which contain GBT440 drug substance in Swedish orange |
Drug: GBT440
GBT440: Capsules which contain GBT440 drug substance in Swedish orange |
- Change in Oxygen Saturation at End of Treatment Period Compared to Baseline [ Time Frame: Days 1 to 90 ]
- Change in Supplemental Oxygen Requirement at End of Treatment Period Compared to Baseline [ Time Frame: Days 1 to 90 ]
- Evaluate the Effect of GBT440 on Resting and Post-exercise Alveolar-arterial O2 Tension Difference [P(A-a) O2] at End of Treatment Period Compared to Baseline [ Time Frame: Days 1 to 90 ]
- Evaluate the Effect of GBT440 on Performance of the 6MWT [ Time Frame: Days 1 to 90 ]
- Evaluate the Effect of GBT440 on IPF Related Symptoms Using Patient Related Outcomes [ Time Frame: Days 1 to 90 ]
- Evaluate Pulmonary Function Using Pulmonary Function Tests (FVC and DLco) [ Time Frame: Days 1 to 90 ]Spirometry measurements will include forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLco).
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Days 1 to 90 ]
- Pharmacokinetic Parameters of GBT440 in Plasma and Whole Blood (Minimum Concentration (Cmin)) [ Time Frame: Day 1 (15 mins post-dose and 2-4h post-dose), Day 15 (pre-dose), Day 30 (pre-dose), Day 60 (pre-dose and 2-4h post-dose), Day 90 (pre-dose), Day 105 (during study visit), and Day 120 (during study visit) ]PK parameters of GBT440 administered daily orally for 90 days in plasma and whole blood, including but not limited to, minimum concentration (Cmin), at steady state.

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Ages Eligible for Study: | 45 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Documented diagnosis of IPF.
- Receiving supplemental oxygen for use at rest.
- Weight ≥ 40 kg.
- Male or female of child bearing potential willing and able to use highly effective methods of contraception from study start to 30 days after the last dose of study drug.
Exclusion Criteria:
- FEV1/FVC < 70%
- History of other interstitial lung diseases.
- Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of screening.
- Corticosteroid (> 10 mg per day of prednisone or an equivalent) administered for 7 days or longer, within 30 days of screening.
- 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).
- Female who is breast-feeding or pregnant
- Current smoker or history of smoking within 3 months from screening

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989168
United States, Alabama | |
Birmingham, Alabama, United States, 35233 | |
United States, Colorado | |
Denver, Colorado, United States, 80206 | |
United States, Louisiana | |
New Orleans, Louisiana, United States, 70122 | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19140 | |
United States, Tennessee | |
Nashville, Tennessee, United States, 37232 | |
United States, Utah | |
Salt Lake City, Utah, United States, 84108 | |
United Kingdom | |
London, United Kingdom, SW3 6NP | |
Manchester, United Kingdom, M23 9QZ | |
Southampton, United Kingdom, SO16 6YD |
Documents provided by Global Blood Therapeutics:
Responsible Party: | Global Blood Therapeutics |
ClinicalTrials.gov Identifier: | NCT02989168 |
Other Study ID Numbers: |
GBT440-026 |
First Posted: | December 12, 2016 Key Record Dates |
Results First Posted: | August 21, 2020 |
Last Update Posted: | August 21, 2020 |
Last Verified: | July 2020 |
Idiopathic pulmonary fibrosis hypoxemia oxygen |
Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Fibrosis Hypoxia |
Pathologic Processes Lung Diseases Respiratory Tract Diseases Signs and Symptoms, Respiratory |