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Gas Therapy

Oral Carbon Monoxide Therapy for Sickle Cell Anemia

Phase 1 & 2

Waitlist Available

Research Sponsored by Hillhurst Biopharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body weight: For 18 years of age and above, between 45 kg and 110 kg (inclusive) and with body mass index (BMI) less than 30 kg/m2. For 14 to 18 years of age, above 35 kg and with BMI less than 30 kg/m2

Male or female 14-55 years of age inclusive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to 44

Awards & highlights

Study Summary

This trial tests a liquid containing carbon monoxide to treat sickle cell disease. It looks at safety, how the body processes it, and how it works.

Who is the study for?

This trial is for non-smoking individuals aged 14-55 with sickle cell disease. Participants must have a stable weight and BMI, normal heart function, and no significant medical issues. Women must not be pregnant and all participants should agree to use effective contraception during the study.Check my eligibility

What is being tested?

The trial tests HBI-002, an oral liquid carbon monoxide treatment for sickle cell disease. Over two weeks, its safety, how well it's tolerated by patients' bodies (tolerability), how the body processes it (pharmacokinetics), and how it affects the disease (pharmacodynamics) are studied.See study design

What are the potential side effects?

While specific side effects of HBI-002 are not listed here, common concerns may include reactions at the administration site or general symptoms like headache or nausea. The study aims to identify any potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18+ years old, weigh between 45-110 kg, and my BMI is under 30 OR I am 14-18 years old, weigh above 35 kg, and my BMI is under 30.

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I am between 14 and 55 years old.

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My blood counts and clotting tests are within the required ranges.

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My heart is healthy based on recent tests.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to 44

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to 44

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to 44 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency and severity of Treatment Emergent Adverse Events, including adverse events of special interest

Secondary outcome measures

Change from baseline in complete blood count (CBC) test parameters, including hemoglobin, hematocrit, red blood cell (RBC) count, white blood cell (WBC) count, and neutrophil count

Change from baseline in inflammation and oxidation, as assessed by levels of protein and/or mRNA indicators, particularly those associated with heme oxygenase-1 (HO-1)

Change from baseline in patient pain levels as measured by an emoji faces pain scale with pain assessment from 0 to 10 and with higher scores indicating more severe pain

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ascending Multiple DoseExperimental Treatment1 Intervention

Drug: HBI-002 (oral liquid carbon monoxide drug product)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HBI-002

2022

Completed Phase 1

~20

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hillhurst Biopharmaceuticals, Inc.Lead Sponsor

1 Previous Clinical Trials

20 Total Patients Enrolled

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,841 Previous Clinical Trials

47,814,097 Total Patients Enrolled

26 Trials studying Sickle Cell Anemia

2,458 Patients Enrolled for Sickle Cell Anemia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants aged 65 or younger being welcomed into this experiment?

"This research project has established the age range of 14 to 55 years old as its recruitment criteria."

Answered by AI

Is there still an opportunity for individuals to be enrolled in this research?

"According to clinicaltrials.gov, this medical research is not currently enrolling patients as the last update was made on November 17th 2023. Nevertheless, there are 410 other studies actively recruiting at present."

Answered by AI

Do I meet the criteria to participate in this medical experiment?

"To fulfill the requirements for this clinical trial, patients must possess a diagnosis of sickle cell anemia and be between 14 to 55 years old. Presently, 8 participants are being recruited."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Safety, Efficacy, and Pharmacokinetic (PK) Study of HBI-002, an Oral Carbon Monoxide (CO) Therapeutic, in Subjects With Sickle Cell Disease (SCD)

2024. "A Safety, Efficacy, and Pharmacokinetic (PK) Study of HBI-002, an Oral Carbon Monoxide (CO) Therapeutic, in Subjects With Sickle Cell Disease (SCD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06144749.

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