Summary

Eligibility
for people ages 18-75 (full criteria)
Location
at UC Davis
Dates
study started
study ends around

Description

Summary

This open-label extension study will evaluate the long-term safety, tolerability and efficacy of orally inhaled seralutinib in subjects who have completed a previous seralutinib study

Official Title

An Open-label Extension Study Evaluating the Long-term Safety and Efficacy of Seralutinib Orally Inhaled for the Treatment of Pulmonary Arterial Hypertension (PAH)

Details

The treatment period is planned to run until the market approval of seralutinib or until the study is terminated.

Keywords

Pulmonary Arterial Hypertension, seralutinib, GB002, PROSERA, PROSERA-EXT, Gereic Dry Powder Inhaler, Seralutinib 90 mg

Eligibility

You can join if…

Open to people ages 18-75

  1. Subjects must have completed a qualifying last visit in a prior seralutinib PAH study on investigational product (IP) and in accordance with the protocol.
  2. Evidence of an informed consent document, signed and dated by the subject, indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any subject-mandated procedures.
  3. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  4. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at enrollment visit before first administration of Investigational Product (IP) in this study.
  5. WOCBP who are not abstinent and intend to be sexually active with a non-sterilized male partner must be willing to use a highly effective method of contraception from consent through 30 days following the last administration of IP.
  6. Male subjects: Non-sterilized male subjects who are not abstinent and intend to be sexually active with a female partner of childbearing potential must use a male condom from consent through 90 days after the last dose of IP.

You CAN'T join if...

  1. Severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or seralutinib administration, unless associated with an ongoing AE and discussed with the Sponsor's medical monitor (MM) (or designee).
  2. Have any other condition or reason that, in the opinion of the Investigator, would prohibit the subject from participating in the study.

Locations

  • UC Davis Health Medical Center accepting new patients
    Sacramento 5389489 California 5332921 95817 United States
  • Valley Advanced Lung Diseases Institute accepting new patients
    Fresno 5350937 California 5332921 93720 United States
  • Department of Veterans Affairs Greater Los Angeles Healthcare System accepting new patients
    Los Angeles 5368361 California 5332921 90073 United States
  • Stanford Healthcare accepting new patients
    Stanford 5398563 California 5332921 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
GB002, Inc.
ID
NCT06274801
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 300 study participants
Last Updated