A Stratified Sickle Event Randomized Trial (ASSERT)

A Phase III Multicenter, 52-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Clinical Efficacy and Safety of ICA-17043 With or Without HU Therapy in Patients With Sickle Cell Disease Who Have Had =>2 Acute Sickle-Related Painful Crises Within the Preceding 12 Months

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00102791

Acronym

ASSERT

Enrollment

297

Registered

2005-02-02

Start date

2005-02-28

Completion date

2007-06-30

Last updated

2008-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Anemia

Brief summary

The purpose of this study is to compare the effects of ICA-17043 to placebo with or without hydroxyurea (an oral drug used for treatment of sickle cell disease) in patients with sickle cell disease who have had 2 or more acute sickle-related painful crises requiring a visit to a medical facility within the past 12 months.

Interventions

DRUGICA-17043

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

Healthy volunteers

Inclusion criteria

* 16 to 65 years of age (inclusive) * Male or female (not capable of becoming pregnant or using appropriate birth control) * Medical history of sickle cell disease * Have a history of at least two or more acute sickle-related painful crises requiring a visit to a medical facility within the preceding 12 months

Exclusion criteria

* Hemoglobin \<4 or \>11 g/dL * On a chronic transfusion program * Has significant active and poorly controlled (unstable) cardiovascular, neurologic, endocrine, hepatic, or renal disorders clearly unrelated to sickle cell disease

Design outcomes

Primary

Measure	Time frame
Sickle Cell Crisis Rate	52 weeks

Secondary

Measure	Time frame
Time to First, Second, and Third Crisis	52 Weeks
Maximum Crisis Morbidity Ranking	52 Weeks
Efficacy Related Laboratory Parameters	52 Weeks
Quality of Life	52 Weeks
Health Economics	52 Weeks

Countries

Brazil, France, Jamaica, Trinidad and Tobago, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026