NBMI Treatment in Patients With Mercury Toxicity

Launched by EMERAMED · Nov 28, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called NBMI for patients who have been exposed to mercury. Mercury poisoning can happen when someone comes into contact with mercury, which can be harmful to the body. The trial aims to see if NBMI is effective and safe in lowering mercury levels in the urine of patients who have been exposed. To participate, patients need to have mercury levels above a certain amount in their urine and must not have received any chelation treatment for at least three months prior to the study. This trial is open to both men and women, including minors with parental consent.

Participants in this study will receive either the NBMI treatment or a placebo (a non-active treatment) for 14 days. Throughout the trial, they will have regular clinic visits to monitor their health and any side effects. So far, previous studies suggest that NBMI has been well tolerated, with only mild side effects reported. This trial is important because it could provide a new way to help people recover from mercury exposure and improve their health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with a history of exposure to sources of mercury release by a known event of direct contact with metallic mercury.
• • All subjects must have signed and dated an informed consent / assent consent form approved by the IRB in accordance with regulatory and institutional guidelines. This form must be obtained before performing any procedure related to the protocol that is not part of the subject's normal regimen.
• • Under age minors must also have a psychological evaluation and documentation of Assent added to the Informed Consent Form.
• • Patients with detectable urinary mercury levels \>10 ug / L at the time of screening.
• • Patients must be willing and able to comply with clinic visits and all study-related procedures.
• • Subjects with no previous chelation treatment or who have stopped receiving chelation treatment for more than 3 months will be enrolled.
• • Participants must have controlled mercury levels, with no severe clinical manifestations, regardless of what the medical treatment may have been.
• Exclusion Criteria:
• • A history of known or suspected hypersensitivity or idiosyncratic reactions to the medication or test excipients. Patients with sulfa-drug sensitivity should be excluded from this study.
• • Levels of mercury in urine / blood at the time of baseline measurement that are below detection threshold.
• • Known history of drug addiction and / or alcoholism.
• • Patients with a known medical condition that, in the opinion of the investigator, could increase the risk associated with participation in the study or with the administration of the study medication (s) under blinded conditions or interfere with the interpretation of the security results.
• • Patients with major surgery or significant traumatic injury who have not recovered at least 14 days before the first dose of the study medications (s) under blind.
• • Subjects with a condition requiring systemic corticosteroid therapy (\> 10 mg daily of prednisone equivalent) or other immunosuppressive medications within 14 days before or during treatment are excluded.
• • Women with positive pregnancy test (urine sample) at the time of screening; or women who are breastfeeding, or are of childbearing age who disagree with taking contraceptives during treatment and until Day 28 after the last dose.