CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 6 enrolled
Drug / intervention
Decitabine (USAN, INN)drug
Likely dose
Decitabine (USAN, INN) 0.2 mg/kgfrom 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/NCT00661726
NCT00661726Phase 2Completed
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A Phase IIA Study of Subcutaneous 5-aza-2'- Deoxycytidine (Decitabine) in Patients With Thalassemia Intermedia

Carelon Research·interventional·Posted Apr 18, 2008·Updated Apr 25, 2014

In Brief

A Phase 2 clinical trial evaluating Decitabine (USAN, INN) for Thalassemia. Completed, enrolled 6 participants across 3 sites in 2 countries.

Detailed Summary

Thalassemia intermedia (TI) is an inherited blood disorder that can cause anemia due to low levels of hemoglobin. Decitabine is a medication that may be effective at increasing hemoglobin levels. This study will evaluate the safety and effectiveness of decitabine at increasing hemoglobin levels in people with TI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThalassemia
CountriesCanada, United States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 18, 2008
Enrollment StartJan 1, 2008
Primary CompletionMay 1, 2010
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.2 years ago

Interventions

Decitabine (USAN, INN)drug

Participants will receive 0.2 mg/kg of decitabine subcutaneously twice a week for 12 weeks. The dose will be reduced for toxicities as needed. The maximum dose of decitabine to be given will be 0.2 mg/kg.