Trial · NCT02989168
Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest
NCT02989168, Phase 2, Terminated, Global Blood Therapeutics; results first posted 2020-08-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest. Trials, record NCT02989168. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02989168
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest
- NCT number
- NCT02989168
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 14 participants, actual
- Lead sponsor
- Global Blood Therapeutics
- Conditions
- Idiopathic Pulmonary Fibrosis, Hypoxemia
- Interventions
- GBT440
- First posted
- 2016-12-12
- Last updated
- 2020-08-21
- Results first posted
- 2020-08-21
- Limitations and caveats
- Since this study was stopped prematurely, no efficacy results will be presented.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Oxygen Saturation at End of Treatment Period Compared to Baseline | Days 1 to 90 | |
| Secondary | Change in Supplemental Oxygen Requirement at End of Treatment Period Compared to Baseline | Days 1 to 90 | |
| Secondary | 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 | Days 1 to 90 | |
| Secondary | Evaluate the Effect of GBT440 on Performance of the 6MWT | Days 1 to 90 | |
| Secondary | Evaluate the Effect of GBT440 on IPF Related Symptoms Using Patient Related Outcomes | Days 1 to 90 | |
| Secondary | Evaluate Pulmonary Function Using Pulmonary Function Tests (FVC and DLco) | Days 1 to 90 | Spirometry measurements will include forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLco). |
| Secondary | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Days 1 to 90 | |
| Secondary | Pharmacokinetic Parameters of GBT440 in Plasma and Whole Blood (Minimum Concentration (Cmin)) | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Oxygen Saturation at End of Treatment Period Compared to Baseline | Days 1 to 90 | Since study was stopped prematurely, complete data for all participants were not analyzable so no efficacy results are presented. | ||
| SECONDARY | Change in Supplemental Oxygen Requirement at End of Treatment Period Compared to Baseline | Days 1 to 90 | Since study was stopped prematurely, complete data for all participants were not analyzable so no efficacy results are presented. | ||
| SECONDARY | 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 | Days 1 to 90 | Since study was stopped prematurely, complete data for all participants were not analyzable so no efficacy results are presented. | ||
| SECONDARY | Evaluate the Effect of GBT440 on Performance of the 6MWT | Days 1 to 90 | Since study was stopped prematurely, complete data for all participants were not analyzable so no efficacy results are presented. | ||
| SECONDARY | Evaluate the Effect of GBT440 on IPF Related Symptoms Using Patient Related Outcomes | Days 1 to 90 | Since study was stopped prematurely, complete data for all participants were not analyzable so no efficacy results are presented. | ||
| SECONDARY | Evaluate Pulmonary Function Using Pulmonary Function Tests (FVC and DLco) | Days 1 to 90 | Since study was stopped prematurely, complete data for all participants were not analyzable so no efficacy results are presented. | ||
| SECONDARY | Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Days 1 to 90 | Participant had at least one dose of study drug | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pharmacokinetic Parameters of GBT440 in Plasma and Whole Blood (Minimum Concentration (Cmin)) | 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) | Complete PK data were not analyzable for any participant. |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | GBT440 900 mg Dose | 11 | Participants | ||
| Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | GBT440 1500 mg Dose | 3 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | GBT440 900 mg Dose | 11 | |
| Overall Study | STARTED | GBT440 1500 mg Dose | 3 | |
| Overall Study | COMPLETED | GBT440 900 mg Dose | 7 | |
| Overall Study | COMPLETED | GBT440 1500 mg Dose | 0 | |
| Overall Study | NOT COMPLETED | GBT440 900 mg Dose | 4 | |
| Overall Study | NOT COMPLETED | GBT440 1500 mg Dose | 3 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Atrial flutter | Cardiac disorders | GBT440 900 mg Dose | 1 | 11 | |
| other | Atrial flutter | Cardiac disorders | GBT440 1500 mg Dose | 0 | 3 | |
| other | Diarrhoea | Gastrointestinal disorders | GBT440 900 mg Dose | 4 | 11 | |
| other | Diarrhoea | Gastrointestinal disorders | GBT440 1500 mg Dose | 1 | 3 | |
| other | Nausea | Gastrointestinal disorders | GBT440 900 mg Dose | 1 | 11 | |
| other | Nausea | Gastrointestinal disorders | GBT440 1500 mg Dose | 2 | 3 | |
| other | Fatigue | General disorders | GBT440 900 mg Dose | 3 | 11 | |
| other | Fatigue | General disorders | GBT440 1500 mg Dose | 1 | 3 | |
| other | Non-cardiac chest pain | General disorders | GBT440 900 mg Dose | 1 | 11 | |
| other | Non-cardiac chest pain | General disorders | GBT440 1500 mg Dose | 0 | 3 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | GBT440 900 mg Dose | 0 | 11 |
| Total, all-cause mortality | GBT440 1500 mg Dose | 0 | 3 |
| Total, other adverse events | GBT440 900 mg Dose | 11 | 11 |
| Total, other adverse events | GBT440 1500 mg Dose | 3 | 3 |
| Total, serious adverse events | GBT440 900 mg Dose | 3 | 11 |
| Total, serious adverse events | GBT440 1500 mg Dose | 2 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| GBT440 900 mg Dose vs GBT440 1500 mg Dose: Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 | Trial comparisons |
| GBT440 900 mg Dose vs GBT440 1500 mg Dose: deaths from any cause | Trial comparisons |
| GBT440 900 mg Dose vs GBT440 1500 mg Dose: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02989168
GET https://conductscience.org/api/trials/v1/NCT02989168/events?page=2