Effect of Simvastatin Treatment on Vaso-occlusive Pain in Sickle Cell Disease

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether simvastatin is effective in reducing the frequency and intensity of vaso-occlusive pain episodes in patients with sickle cell disease.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital & Research Center Oakland; UCSF Benioff Children's Hospital Oakland
• Collaborator: University of California, Los Angeles
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

• Sickle cell disease (HbSS or S/β0 thalassemia)

• ≥ 3 vaso-occlusive pain episodes in the year prior to enrollment

• Age ≥ 10 years

• Weight > 30 kg

Exclusion Criteria:

• Creatine kinase (CK) > UNL

• Total cholesterol < 90 mg/dL, or triglycerides <30mg/dL

• Renal dysfunction (Creatinine > 1.5-fold UNL)

• Hepatic dysfunction (ALT > 2-fold UNL)

• Treatment with drugs having known metabolic interactions with statins within the past 30 days

• Vaso-occlusive pain requiring hospitalization within past 30 days

• Red blood cell transfusion within the past 30 days

• Pregnancy/lactation

• Musculoskeletal disorder associated with an elevated CK level

• Past or present history of substance abuse (alcohol, cocaine, amphetamines, heroin)

• Chronic pain caused by avascular necrosis of the bone (AVN) or leg ulcers, and pain due to trauma or causes other than SCD.

• Major cognitive or neurological impairments that may hamper the ability to use the smartphone or complete the electronic pain diary in this study