Chelation Therapy of Iron Overload With Pyridoxal Isonicotinoyl Hydrazone

PHASE2CompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

June 5, 1989

Primary Completion Date

March 31, 1993

Study Completion Date

March 31, 1995

Conditions
Anemia (Iron-Loading)Beta-ThalassemiaHematologic DiseasesHemoglobinopathiesThalassemiaIron Overload
Interventions
DRUG

Chelation therapy

After an initial 21 day balance study to demonstrate that a selected dose of PIH produced sufficient iron excretion, patients were begun on chronic therapy. PIH or placebo were given on days 4 to 9 and days 13 to 18 in a randomized, double-blind, cross-over design.

OTHER

Placebo

Placebo given at same time points as the Intervetnion for each clinical condition.

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Case Western Reserve University

OTHER