Idiopathic Pulmonary FibrosisPhase 2ZephyrNCT02989168
Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest
A Phase 2 study testing GBT440 in people with Idiopathic Pulmonary Fibrosis and Hypoxemia, run by Global Blood Therapeutics at 9 sites in 2 countries.
Trial summary
This is an open label study in which eligible IPF subjects who are using supplemental oxygen at rest will receive GBT440 orally daily. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis, Hypoxemia
- What is being tested?
- GBT440
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Nov 2016to 23 Oct 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United States6 sites
Study site
Birmingham, Alabama, 35233
Study site
Denver, Colorado, 80206
Study site
Nashville, Tennessee, 37232
Study site
New Orleans, Louisiana, 70122
Study site
Philadelphia, Pennsylvania, 19140
Study site
Salt Lake City, Utah, 84108
United Kingdom3 sites
Study site
London, SW3 6NP
Study site
Manchester, M23 9QZ
Study site
Southampton, SO16 6YD
About this study
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)
This is an open label study in which eligible IPF subjects who are using supplemental oxygen at rest will receive GBT440 orally daily.
- Conditions
- Idiopathic Pulmonary Fibrosis, Hypoxemia
- Being tested
- GBT440
- Keywords
- Idiopathic pulmonary fibrosis, hypoxemia, oxygen
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBT440Drug
GBT440: Capsules which contain GBT440 drug substance in Swedish orange
| Study group | Role | What they receive |
|---|---|---|
| GBT440 900 mg Dose | Experimental | Part A, 900 mg
GBT440: Capsules which contain GBT440 drug substance in Swedish orange Receives: Drug: GBT440 |
| GBT440 1500 mg Dose | Experimental | Part B , 1500 mg
GBT440: Capsules which contain GBT440 drug substance in Swedish orange Receives: Drug: GBT440 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygen Saturation at End of Treatment Period Compared to Baseline
Measured: Days 1 to 90
Secondary outcomes (7)
Change in Supplemental Oxygen Requirement at End of Treatment Period Compared to Baseline
Measured: 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
Measured: Days 1 to 90
Evaluate the Effect of GBT440 on Performance of the 6MWT
Measured: Days 1 to 90
Evaluate the Effect of GBT440 on IPF Related Symptoms Using Patient Related Outcomes
Measured: Days 1 to 90
Evaluate Pulmonary Function Using Pulmonary Function Tests (FVC and DLco)
Spirometry measurements will include forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLco).
Measured: Days 1 to 90
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Measured: Days 1 to 90
Pharmacokinetic Parameters of GBT440 in Plasma and Whole Blood (Minimum Concentration (Cmin))
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion23 Oct 2017
- Study completion23 Oct 2017
Why it stopped: The study was terminated due to lack of clinically meaningful benefit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Global Blood Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989168
- Sponsor's protocol ID
- GBT440-026
- Acronym
- Zephyr
- Status last verified
- Jul 2020
- First submitted
- 28 Nov 2016
- Last updated
- 21 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02989168
- Acronym / sponsor ID
- Zephyr / GBT440-026
- Conditions
- Idiopathic Pulmonary Fibrosis, Hypoxemia
- Keywords
- Idiopathic pulmonary fibrosis, hypoxemia, oxygen
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to lack of clinically meaningful benefit
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Global Blood TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- 23 Oct 2017 (actual)
- Study completion
- 23 Oct 2017 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Posted 21 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label study in which eligible IPF subjects who are using supplemental oxygen at rest will receive GBT440 orally daily.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBT440 900 mg Dose | Experimental | Drug: GBT440Part A, 900 mg GBT440: Capsules which contain GBT440 drug substance in Swedish orange |
| GBT440 1500 mg Dose | Experimental | Drug: GBT440Part B , 1500 mg GBT440: Capsules which contain GBT440 drug substance in Swedish orange |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GBT440GBT440: Capsules which contain GBT440 drug substance in Swedish orange | Drug | GBT440 1500 mg Dose, GBT440 900 mg Dose |
Primary outcome
Change in Oxygen Saturation at End of Treatment Period Compared to Baseline
Time frame: Days 1 to 90
7 secondary outcomes
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
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GBT440 in people with Idiopathic Pulmonary Fibrosis and Hypoxemia, run by Global Blood Therapeutics at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Oxygen Saturation at End of Treatment Period Compared to Baseline (time frame: Days 1 to 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2020.