Anemia Severe Clinical Trials

Anemia Severe clinical trials

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NCT ID: NCT03633604 Available - Anemia Severe Clinical Trials

Expanded Access IND Administration of HBOC-201 in Patients With Severe Acute Anemia

Start date: n/a
Phase:
Study type: Expanded Access

HBOC-201 provides an oxygen treatment bridge and can be used to eliminate, delay, or reduce the need for red blood cell transfusions in anemic patients This is an expanded access IND protocol, and will provide treatment with HBOC-201 to severely anemic adults for whom blood is not an option

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.