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NCT04816604 · ClinicalTrials.gov registry record · Phase 2
Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
A Phase 2 study of Pulmonary Arterial Hypertension, sponsored by GB002, Inc., a wholly owned subsidiary of Gossamer Bio.
- Active
- Registry status
- Phase 2
- Development phase
- 74
- Enrollment target
- 20
- Study locations
NCT04816604: Active Phase 2 study of Pulmonary Arterial Hypertension, sponsored by GB002, Inc., a wholly owned subsidiary of Gossamer Bio.
NCT04816604 is a Phase 2 study of Pulmonary Arterial Hypertension that is active but no longer recruiting, run by GB002, Inc., a wholly owned subsidiary of Gossamer Bio. The registered enrollment target is 74 participants, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (84% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04816604, a Phase 2 study of Pulmonary Arterial Hypertension, is active but no longer recruiting, sponsored by GB002, Inc., a wholly owned subsidiary of Gossamer Bio.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 74 participants
- Enrollment target
- 20
- Study locations
Study Summary
This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.
Conditions Studied
Interventions
- DRUG GB002 (seralutinib)
- DEVICE Generic Dry Powder Inhaler
Study Locations (20)
New York
- NYU Langone Health - New York
- New York Presbyterian Hospital - Weill Cornell Medicine - New York
- University of Rochester Medical Center - Rochester
Other
- Všeobecná fakultní nemocnice v Praze - Prague
- AP-HP Hôpital de Bicêtre - Le Kremlin-Bicêtre
- DRK Kliniken Berlin - Berlin
California
- University of California, Davis Medical Center - Sacramento
- Medical Corporation - Santa Barbara
Florida
- Mayo Clinic - Jacksonville
- Cleveland Clinic Florida - Weston
Kansas
- University of Kansas Medical Center - Kansas City
Kentucky
- Norton Pulmonary Specialists - Louisville
Massachusetts
- Tufts Medical Center - Boston
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2021-04-05 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What the registry record for NCT04816604 still lists
NCT04816604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 461-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 2 interventions - of which GB002 (seralutinib) is the first listed.
NCT04816604 names 20 study sites across 14 states, led by New York, Other, California.
Frequently Asked Questions
What is clinical trial NCT04816604 about?
NCT04816604 is a clinical study titled "Open-label Extension Study of GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)". This open-label extension study will evaluate the long-term effects of GB002 (seralutinib) in subjects who previously participated in a GB002 PAH study.
What is the current status of trial NCT04816604?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 74 participants. The study started on 2021-04-05. Estimated completion is 2027-12.
What conditions does trial NCT04816604 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT04816604?
The interventions under investigation include: GB002 (seralutinib) (DRUG), Generic Dry Powder Inhaler (DEVICE).
Who is sponsoring clinical trial NCT04816604?
This trial is sponsored by GB002, Inc., a wholly owned subsidiary of Gossamer Bio, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04816604 being conducted?
This trial has 20 study locations across California, Florida, Kansas, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04816604's enrollment target sits among peer trials
74 23rd of 63 higher than 41 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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