At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 120 enrolled

Drug / intervention

Chelation therapy +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00000588

NCT00000588Phase 2Completed

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Chelation Therapy of Iron Overload With Oral Pyridoxal Isonicotinoyl Hydrazone

Case Western Reserve University·interventional·Posted Oct 28, 1999·Updated Sep 21, 2022

In Brief

A Phase 2 clinical trial evaluating Chelation therapy and Placebo for Anemia (Iron-Loading) and 5 related conditions. Completed, enrolled 120 participants.

Detailed Summary

To demonstrate the safety and effectiveness of orally-administered pyridoxal isonicotinoyl hydrazone (PIH) for the chronic treatment of iron overload.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAnemia (Iron-Loading), Beta-Thalassemia, Hematologic Diseases, Hemoglobinopathies, Thalassemia, Iron Overload

Countries--

CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished

198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 1989

Primary CompletionMar 1993

Study CompletionMar 1995

First PostedOct 1999

TodayJul 2026

First PostedOct 28, 1999

Enrollment StartJun 5, 1989

Primary CompletionMar 31, 1993

Study CompletionMar 31, 1995

TodayJul 2, 2026

Enrollment to primary: 3.8 yearsPosted 26.7 years ago

Interventions

Chelation therapydrug

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.

Placeboother

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