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Summary

for people ages 45–80 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

This study is a randomized, double-blind, placebo-controlled trial in which eligible IPF subjects will be randomized to receive GBT440 or Placebo orally daily.

Official Title

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)

Keywords

Idiopathic Pulmonary Fibrosis

Eligibility

You can join if…

Open to people ages 45–80

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Salt Lake City, Utah, 84108, United States
  • Denver, Colorado, 80206, United States
  • Kansas City, Kansas, 66160, United States
  • New Orleans, Louisiana, 70122, United States
  • Nashville, Tennessee, 37212, United States
  • Birmingham, Alabama, 35233, United States
  • Charleston, South Carolina, 29425, United States
  • Falls Church, Virginia, 22042, United States
  • Philadelphia, Pennsylvania, 19145, United States
  • Miami, Florida, 33136, United States
  • New York, New York, 10032, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Global Blood Therapeutics
ID
NCT02846324
Phase
Phase 2
Study Type
Interventional
Last Updated
April 1, 2017
I’m interested in this study!