Status:
TERMINATED
Voxelotor for Improving Oxygen Saturation in Adults
Lead Sponsor:
Duke University
Conditions:
Acute Lung Injury
End Stage Lung Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the efficacy of voxelotor for increasing oxygen saturation in 20 patients with hypoxemia. Specifically, the SpO2/FiO2 ratio will be compared before and after vo...
Detailed Description
Purpose of the study: Primary study objective is to evaluate the efficacy of voxelotor for increasing oxygen saturation in patients with hypoxic hypoxemia as a result of end-stage lung disease or acut...
Eligibility Criteria
Inclusion
- Oxygen dependency due to an end-staged lung disease (pre-lung transplant population) or ALI/acute lung injury (for example but not limited to primary allograft dysfunction, infectious pneumonia, aspiration, non-cardiogenic pulmonary edema). ALI will be defined as per Berlin criteria with a P/F ratio \<100 denoting severe ARDS, \<200 denoting moderate and \<300 mild ARDS. ALI and mild ARDS are considered synonymous. In the event of inability to obtain arterial blood gas analysis to calculate a P/F ratio, we will consider a range of patients requiring standard nasal cannulae flowing at 6l/min to maintain SaO2 \>90% as ALI, and Salter High -Flow nasal cannulae at 12-15l/min in order to maintain SaO2\>85% as severe ARDS.
- At least 48 hours of stable, increased oxygen requirement or ventilatory support prior to the start of drug administration if consented.
Exclusion
- Minors (\<18 years)
- Pre-existing congestive cardiac failure (NYHA III or IV)
- Medically significant, non-revascularized coronary artery disease
- Inability to obtain informed consent from LAR
- Pregnancy
- Incarcerated individual.
- Failure of another vital organ.
- Severe hepatic impairment (Childs-Pugh C) or liver enzymes \> 4x upper limit of normal (ULN) at screening.
- Unstable acute kidney injury/rising creatinine.
- Chronic neuromuscular disease requiring mechanical ventilation
- Not anticipated to survive \>48 hours
- Limited therapeutic goals (do not resuscitate, etc.)
- History of Pulmonary Embolism (PE)
- Requires treatment with Fluconazole or other moderate and strong CYP3A4 inhibitors listed in section 5.6
- A patient with active bleeding complications requiring more than 1 unit of blood transfusion per day, as the PK and PD of Voxelotor in the setting of blood loss and blood transfusion is unknown.
- Participated in another clinical trial of an investigational drug (or medical device) within 30 days or 5-half-lives, whichever is longer, prior to consent, or is currently participating in another trial of an investigational or marketed drug (or medical device)
- Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Any condition or concomitant medication that confounds the ability to interpret data from the study or safely use Voxelotor.
Key Trial Info
Start Date :
May 3 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 4 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05289570
Start Date
May 3 2022
End Date
July 4 2023
Last Update
July 24 2024
Active Locations (1)
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1
Duke University Health System
Durham, North Carolina, United States, 27710