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Report for Clinical Trial NCT00395629

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase I/II Open Label, Dose Escalation Trial and a Six Month Extension to Explore the Safety and Efficacy of ICL670 in Patients With Iron Overload Resulting From Hereditary Hemochromatosis.

Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y.

NCT00395629 Iron Overload Hereditary Hemochromatosis
MeSH: Hemochromatosis Iron Overload

1 Interventions

Name: Deferasirox (ICL670)

Type: Drug

ICL670 (Deferasirox)


Primary Outcomes

Description: Mean absolute change in serum ferritin from baseline to the end of the extension study.

Measure: Absolute Change of Serum Ferritin From Baseline to the End of Extension, by Dose Cohort (Extension Per-protocol Population)

Time: 0 to 48 weeks

Secondary Outcomes

Description: A blood sample was collected just prior to administration of the next dose of Deferasirox (pre-dose trough level) or approximately 24 hours after the previous dose at weeks 4, 8, 12, 16, 20 and 24. The mean trough concentration at each time point was calculated.

Measure: Trough Concentrations of Deferasirox (ICL670), by Dose Cohort (Per-protocol Population)

Time: 4, 8, 12, 16, 20, and 24 weeks

Purpose: Treatment

Allocation: Non-Randomized

Single Group Assignment


There is one SNP

SNPs


1 C282Y

A Phase I/II Open Label, Dose Escalation Trial and a Six Month Extension to Explore the Safety and Efficacy of ICL670 in Patients With Iron Overload Resulting From Hereditary Hemochromatosis.. Safety and Efficacy of Deferasirox (ICL670) in Patients With Iron Overload Resulting From Hereditary Hemochromatosis Brief Summary: This study was designed to explore a safe dose and characterize the preliminary safety and efficacy of ICL670 in adult patients with previously documented history of homozygous C282Y. --- C282Y ---

The mean trough concentration at each time point was calculated.. Inclusion Criteria: - Age 18 years of age or older - Male or female patients homozygous for the C282Y mutation. --- C282Y ---

Inclusion Criteria: - Age 18 years of age or older - Male or female patients homozygous for the C282Y mutation. --- C282Y ---



HPO Nodes