TerminatedPhase 2

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

Stopped: This study was terminated due to treatment stop resulting in an inability to draw conclusions from the data. Evaluation of nonclinical rat findings is ongoing.

United States, Canada, Italy30 participantsStarted 2012-08-14

Plain-language 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

Who can participate

Age range6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Post-menopausal (12 consecutive months of spontaneous amenorrhea), or
✓. Surgically sterile, or
✓. Females of child-bearing potential must have a negative urine pregnancy test at the Qualification and Enrollment Visit prior to dosing on Day 1. Females of child-bearing potential must agree to abstain from sexual activity that could result in pregnancy or agree to use acceptable methods of contraception.

What they're measuring

Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 24 (Cycle 1)

Timeframe: Baseline, Week 24 (Cycle 1)

Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 48 (Cycle 1)

Timeframe: Baseline, Week 48 (Cycle 1)

Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 24 (Cycle 2)

Timeframe: Baseline, Week 24 (Cycle 2)

Change From Baseline in Cardiac T2* Values at Week 24 (Cycle 1)

Timeframe: Baseline, Week 24 (Cycle 1)

Change From Baseline in Cardiac T2* Values at Week 48 (Cycle 1)

Timeframe: Baseline, Week 48 (Cycle 1)

Change From Baseline in Cardiac T2* Values at Week 24 (Cycle 2)

Timeframe: Baseline, Week 24 (Cycle 2)

Trial details

NCT IDNCT01671111

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-04-24

Results submitted2015-07-10

View on ClinicalTrials.gov More Iron Overload Due to Repeated Red Blood Cell Transfusions trials

Who can participate

Age range6 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Post-menopausal (12 consecutive months of spontaneous amenorrhea), or
✓. Surgically sterile, or
✓. Females of child-bearing potential must have a negative urine pregnancy test at the Qualification and Enrollment Visit prior to dosing on Day 1. Females of child-bearing potential must agree to abstain from sexual activity that could result in pregnancy or agree to use acceptable methods of contraception.

What they're measuring

Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 24 (Cycle 1)

Timeframe: Baseline, Week 24 (Cycle 1)

Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 48 (Cycle 1)

Timeframe: Baseline, Week 48 (Cycle 1)

Change From Baseline in Ferriscan® R2 Liver Iron Concentrations (LIC) at Week 24 (Cycle 2)

Timeframe: Baseline, Week 24 (Cycle 2)

Change From Baseline in Cardiac T2* Values at Week 24 (Cycle 1)

Timeframe: Baseline, Week 24 (Cycle 1)

Change From Baseline in Cardiac T2* Values at Week 48 (Cycle 1)

Timeframe: Baseline, Week 48 (Cycle 1)

Change From Baseline in Cardiac T2* Values at Week 24 (Cycle 2)

Timeframe: Baseline, Week 24 (Cycle 2)