Other Clinical Trial - Study for Transfusionally Iron Overloaded Children,

Clinical Trial Summary

The purpose of this extension study is to evaluate SSP-004184AQ in patients with transfusional iron overload and to provide data on long term safety and efficacy. SSP-004184AQ is an iron chelator under development for chronic daily oral administration to patients with transfusional iron overload

See also
Status	Clinical Trial	Phase
Terminated	`NCT01604941` - Pharmacokinetics of SSP-004184 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy	Phase 2
Completed	`NCT03802916` - Safety and Acceptability of Deferiprone Delayed Release Tablets in Patients With Systemic Iron Overload	Phase 2
Completed	`NCT02477631` - Effect of Deferiprone on Oxidative-Stress and Iron-Overload in Low Risk Transfusion-Dependent MDS Patients	Phase 2

See also

Status

Clinical Trial

Phase

Terminated

NCT01604941 - Pharmacokinetics of SSP-004184 in the Treatment of Chronic Iron Overload Requiring Chelation Therapy

Phase 2

Completed

NCT03802916 - Safety and Acceptability of Deferiprone Delayed Release Tablets in Patients With Systemic Iron Overload

Phase 2

Completed

NCT02477631 - Effect of Deferiprone on Oxidative-Stress and Iron-Overload in Low Risk Transfusion-Dependent MDS Patients

Phase 2

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.

NCT number	NCT01671111
Study type	Interventional
Source	Takeda
Contact
Status	Terminated
Phase	Phase 2
Start date	August 14, 2012
Completion date	April 24, 2014

Study for Transfusionally Iron Overloaded Children, Adolescents and Adults Using FBS0701 (SSP-004184)

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms