Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02989168
• Date of registration: 28/11/2016
• Prospective Registration: No
• Primary sponsor: Global Blood Therapeutics
• Public title: Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest Zephyr
• Scientific 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)
• Date of first enrolment: November 2016
• Target sample size: 14
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02989168
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United Kingdom, United States

Key inclusion & exclusion criteria

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



Age minimum: 45 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypoxemia

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: GBT440

Primary Outcome(s)

Change in Oxygen Saturation at End of Treatment Period Compared to Baseline [Time Frame: Days 1 to 90]

Secondary Outcome(s)

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 IPF Related Symptoms Using Patient Related Outcomes [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)]

Evaluate the Effect of GBT440 on Performance of the 6MWT [Time Frame: Days 1 to 90]

Evaluate Pulmonary Function Using Pulmonary Function Tests (FVC and DLco) [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]

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 [Time Frame: Days 1 to 90]

Secondary ID(s)

GBT440-026

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02989168