NCT01033227

Safety and Efficacy of Sodium Nitrite in Sickle Cell Disease

A Safety and Efficacy Evaluation of Sodium Nitrite Injection for the Treatment of Vaso-Occlusive Crisis Associated With Sickle Cell Disease

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 8 Years – 23 Years
• Healthy volunteers: Not accepted

Summary

This study will determine if administration of sodium nitrite is safe and can improve small vessel blood flow and tissue oxygenation when given as an additional treatment in patients with acute vaso-occlusive crisis (pain crisis) associated with sickle cell disease.

Detailed description

Nitric oxide (NO) is a naturally occuring chemical that relaxes blood vessels and helps improve blood flow. The pain associated with vaso-occlusive crisis (pain crisis) in sickle cell disease is caused in part by lack of oxygen and increased tissue acid because blood flow is blocked by stiff sickle red cells. Administration of sodium nitrite should generate nitric oxide in this area of hypoxia and acidosis and improve blood flow.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DRUG	sodium nitrite injection, usp	Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose).

Timeline

• Start date: 2009-12-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-12-16
• Last updated: 2017-10-17
• Results posted: 2017-02-08

Locations

1 site across 1 country: United States