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

Completed · Phase 1/Phase 2

Conditions studied: Sickle Cell Disease

In brief

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.

Key facts

Study ID

NCT01702246

Run by

UCSF Benioff Children's Hospital Oakland

People needed

24

Starts

2012-02-01

Expected to finish

2015-06-01

Last updated by the study team

2016-12-19

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Children's Hospital and Research Center Oakland — Oakland, California, United States

Full record on ClinicalTrials.gov

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