Pilot Study of Fructose for Sickle Cell Crisis

Status Completed

Clinical Trial Summary

OBJECTIVES: I. Evaluate the efficacy and tolerability of fructose administered every 6 hours for up to 72 hours to patients in active sickle cell crisis.

II. Obtain tolerability information in selected patients treated with fructose for more than 72 hours.

Clinical Trial Description

PROTOCOL OUTLINE: In the first part of the study, patients are block-randomized (3:1) to a single intravenous dose of fructose or placebo. The dose of fructose is escalated in each successive group after tolerability data are evaluated.

In the second part of the study, patients are randomly assigned (1:1) to fructose or placebo administered intravenously every 6 hours for 72 hours. The dose of fructose is the highest well-tolerated dose determined in Study 1 or the most tolerated dose for the patient. Patients who just completed Study 1 may participate if they are clearly in a separate crisis and continue to meet entry criteria.

Patients whose symptoms persist for more than 72 hours after fructose or placebo are eligible to receive additional fructose every 6 hours until symptoms subside. ;

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00004797
Study type	Interventional
Source	Office of Rare Diseases (ORD)
Contact
Status	Completed
Phase	N/A
Start date	August 1995

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04134299` - To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease	N/A
Completed	`NCT04581356` - Voxelotor Sickle Cell Exercise Study	Phase 4
Completed	`NCT02712346` - The Role of Endothelin-1 in Sickle Cell Disease	Phase 1
Withdrawn	`NCT02162225` - Study of Beet Juice for Patients With Sickle Cell Anemia	Phase 2
Completed	`NCT01976416` - Novel Use Of Hydroxyurea in an African Region With Malaria	Phase 3
Completed	`NCT01137721` - State Of The Art Functional Imaging In Sickle Cell Disease
Withdrawn	`NCT00937144` - Endothelial Function in Patients With Sickle Cell Anemia Before and After Sildenafil	Phase 4
Terminated	`NCT01350232` - Treatment of Sickle Cell Anemia With Stem Cell Transplant	N/A
Completed	`NCT00512564` - Clinical and Laboratory Assessment of Iron Overload in Sickle Cell Anemia and Sickle Cell Thalassemia	N/A
Completed	`NCT00512226` - Iron Overload Assesment in Sickle Cell Anemia and Sickle Cell Thalassemia	N/A
Completed	`NCT00004143` - Allogeneic Mixed Chimerism Stem Cell Transplant Using Campath for Hemoglobinopathies & Bone Marrow Failure Syndromes	Phase 2
Completed	`NCT00004412` - Phase II Randomized Trial:Arginine Butyrate Plus Standard Local Therapy in Patients With Refractory Sickle Cell Ulcers	Phase 2
Withdrawn	`NCT01925001` - Phase 2 Study of MP4CO to Treat Vaso-occlusive Sickle Crisis	Phase 2
Completed	`NCT01848691` - Carbon Monoxide Monitor for the Measurement of End-Tidal Carbon Monoxide Levels in Children With or Without Hemolysis	N/A
Completed	`NCT01783990` - Pediatric Hydroxyurea Phase III Clinical Trial (BABY HUG) Follow-up Observational Study II Protocol
Completed	`NCT00874172` - Effectiveness of New Analgesic Strategy Compared to the Usal Antalgic Strategy	N/A
Completed	`NCT01000155` - Efficacy of Vorinostat to Induce Fetal Hemoglobin in Sickle Cell Disease	Phase 2
Completed	`NCT00399074` - Sulfadoxine- Pyrimethamine Versus Weekly Chloroquine for Malaria Prevention in Children With Sickle Cell Anemia	Phase 3
Completed	`NCT00236093` - Extension Study of ACTIQ Treatment for Children and Adolescents With Breakthrough Pain	Phase 2
Completed	`NCT00004492` - Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia	Phase 1/Phase 2