Sickle Cell DiseasePhase 1/2NCT00508027

Simvastatin (Zocor) Therapy in Sickle Cell Disease

A Phase 1/2 study testing Simvastatin in people with Sickle Cell Disease, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 13 years and older
Conditions the study is for: Sickle Cell Disease
What is being tested?: Simvastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteUnited States
Study dates: Jun 2007to Dec 2011
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Established diagnosis of sickle cell disease (HbSS, SC or Sβ-thalassemia)
Age greater than or equal to thirteen years
Weight greater than or equal to 35 kg

Who cannot join

Renal dysfunction (Serum Creatinine > 1.5 UNL)
Hepatic dysfunction (ALT > 2X UNL)
Pretreatment total cholesterol < 100 mg/dL or triglycerides < 30 mg/dL
Pretreatment baseline creatine kinase >1X UNL (215 U/L)
Pregnancy/lactation
RBC transfusion in the last 30 days

Show all 13Show fewer

Vaso-Occlusive Event needing hospitalization in the past 30 days
Treatment with any statin drugs within the past 30 days
Treatment with drugs having known metabolic interactions with statin drugs (e.g. cytochrome P450 3A4 metabolism), including ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, azithromycin, niacin (nicotinic acid), digoxin, coumadin, sildenafil or amiodarone within the past 30 days
Treatment (past or present) with amiodarone
Musculoskeletal disorder associated with an elevated creatine kinase level
Past or present history of substance abuse (alcohol, cocaine, amphetamines, heroin, PCP)
Allergy to statins

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital and Research Center Oakland
Oakland, California, 94609

Other trials in United States

About this study

Official title: Phase I/II Study of Simvastatin (Zocor) Therapy in Sickle Cell Disease

Recent clinical and experimental data indicate that statins have effects beyond cholesterol lowering that may be beneficial in sickle cell disease by protecting the vascular endothelium. Statins have been shown to attenuate endothelial dysfunction through their anti-inflammatory, anti-oxidant and anti-thrombotic properties. This phase I/II dose-escalating trial is designed to assess the safety and potential clinical efficacy of oral simvastatin (Zocor)in adolescents and adults with sickle cell disease (SCD).

Read the detailed description

Although statins have been used extensively for their cholesterol-lowering effects, recent clinical and experimental data indicate that statins regulate yet other processes, many of which play a major role in sickle cell disease (SCD). Independent of their cholesterol-lowering effects, statins have been shown to prevent damage to blood vessels in several ways, through upregulation of endothelial nitric oxide (NO)and decreased inflammation. Numerous studies documenting the protective effects of statins, together with data showing the therapeutic role of NO in SCD, provide the basis for investigating the potential clinical benefit of simvastatin in SCD.

Data supporting the safety and tolerability of simvastatin in patients with SCD are now needed. For this phase I/II dose-escalation study of oral simvastatin in SCD, we propose the following specific aims:

To obtain preliminary efficacy data on the effects of oral simvastatin on plasma biomarkers of endothelial injury in patients with SCD, and
To assess the safety and tolerability of oral simvastatin in patients with SCD.

Conditions: Sickle Cell Disease
Being tested: Simvastatin
Keywords: sickle cell disease, simvastatin, statin drugs, nitric oxide donors, vascular injury
Medical subject headings: Anemia, Sickle Cell, Vascular System Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SimvastatinDrug
Also called Zocor
Comparison of 3 dosages of simvastatin given in a dose-escalating fashion. 20 mg, 40 mg, or 80 mg PO QD x 21 days followed by a drug taper x 4 days.

Study groups in NCT00508027
Study group	Role	What they receive
Simvastatin, Dose Escalation	Other	There are no arms in this study. Simvastatin will be given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day). Receives: Drug: Simvastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Total Cholesterol Level
Change in serum total cholesterol level after treatment with simvastatin
Measured: Baseline, 21 days
Change in Hemoglobin Level
Change in plasma hemoglobin (Hb) level after treatment with simvastatin
Measured: Baseline, 21 days
Change in Serum Creatine Kinase Levels
Change in serum creatine kinase (CK) levels after treatment with simvastatin
Measured: Baseline, 21 days
Change in Serum Alanine Transaminase (ALT) Levels
Change in serum alanine transaminase (ALT) after treatment with simvastatin
Measured: Baseline, 21 days
Change in Serum Creatinine Levels
Change in serum creatinine (Cr) levels after treatment with simvastatin
Measured: Baseline, 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Dec 2011

First posted27 Jul 2007 (estimated)
Study startJun 2007
Primary completionDec 2011
Study completionDec 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (18)Papers the sponsor has linked to this study.
Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00508027
Sponsor's protocol ID: 1R01FD003080-01A1
Status last verified: Aug 2013
First submitted: 26 Jul 2007
Last updated: 17 Sep 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Hebbel RP. Extracorpuscular factors in the pathogenesis of sickle cell disease. Am J Pediatr Hematol Oncol. 1982 Fall;4(3):316-9.
PubMed 7149170
Hebbel RP. Perspectives series: cell adhesion in vascular biology. Adhesive interactions of sickle erythrocytes with endothelium. J Clin Invest. 1997 Jun 1;99(11):2561-4. doi: 10.1172/JCI119442. No abstract available.
PubMed 9169483
Hebbel RP. Special issue of Microcirculation: examination of the vascular pathobiology of sickle cell anemia. Foreword. Microcirculation. 2004 Mar;11(2):99-100. No abstract available.
PubMed 15280085
Kaul DK, Liu XD, Choong S, Belcher JD, Vercellotti GM, Hebbel RP. Anti-inflammatory therapy ameliorates leukocyte adhesion and microvascular flow abnormalities in transgenic sickle mice. Am J Physiol Heart Circ Physiol. 2004 Jul;287(1):H293-301. doi: 10.1152/ajpheart.01150.2003. Epub 2004 Mar 4.
PubMed 15001449
Wood KC, Hebbel RP, Granger DN. Endothelial cell P-selectin mediates a proinflammatory and prothrombogenic phenotype in cerebral venules of sickle cell transgenic mice. Am J Physiol Heart Circ Physiol. 2004 May;286(5):H1608-14. doi: 10.1152/ajpheart.01056.2003. Epub 2004 Jan 2.
PubMed 14704223
Belcher JD, Marker PH, Weber JP, Hebbel RP, Vercellotti GM. Activated monocytes in sickle cell disease: potential role in the activation of vascular endothelium and vaso-occlusion. Blood. 2000 Oct 1;96(7):2451-9.
PubMed 11001897
Haffner SM, Alexander CM, Cook TJ, Boccuzzi SJ, Musliner TA, Pedersen TR, Kjekshus J, Pyorala K. Reduced coronary events in simvastatin-treated patients with coronary heart disease and diabetes or impaired fasting glucose levels: subgroup analyses in the Scandinavian Simvastatin Survival Study. Arch Intern Med. 1999 Dec 13-27;159(22):2661-7. doi: 10.1001/archinte.159.22.2661.
PubMed 10597756
Laufs U, Wassmann S, Hilgers S, Ribaudo N, Bohm M, Nickenig G. Rapid effects on vascular function after initiation and withdrawal of atorvastatin in healthy, normocholesterolemic men. Am J Cardiol. 2001 Dec 1;88(11):1306-7. doi: 10.1016/s0002-9149(01)02095-1. No abstract available.
PubMed 11728362
Hebbel RP, Vercellotti GM. The endothelial biology of sickle cell disease. J Lab Clin Med. 1997 Mar;129(3):288-93. doi: 10.1016/s0022-2143(97)90176-1. No abstract available.
PubMed 9042813
Solovey A, Lin Y, Browne P, Choong S, Wayner E, Hebbel RP. Circulating activated endothelial cells in sickle cell anemia. N Engl J Med. 1997 Nov 27;337(22):1584-90. doi: 10.1056/NEJM199711273372203.
PubMed 9371854
Solovey A, Gui L, Key NS, Hebbel RP. Tissue factor expression by endothelial cells in sickle cell anemia. J Clin Invest. 1998 May 1;101(9):1899-904. doi: 10.1172/JCI1932.
PubMed 9576754
Reiter CD, Gladwin MT. An emerging role for nitric oxide in sickle cell disease vascular homeostasis and therapy. Curr Opin Hematol. 2003 Mar;10(2):99-107. doi: 10.1097/00062752-200303000-00001.
PubMed 12579034
Gladwin MT, Crawford JH, Patel RP. The biochemistry of nitric oxide, nitrite, and hemoglobin: role in blood flow regulation. Free Radic Biol Med. 2004 Mar 15;36(6):707-17. doi: 10.1016/j.freeradbiomed.2003.11.032.
PubMed 14990351
Platt OS. Sickle cell anemia as an inflammatory disease. J Clin Invest. 2000 Aug;106(3):337-8. doi: 10.1172/JCI10726. No abstract available.
PubMed 10930436
Brown MD, Wick TM, Eckman JR. Activation of vascular endothelial cell adhesion molecule expression by sickle blood cells. Pediatr Pathol Mol Med. 2001 Jan-Feb;20(1):47-72.
PubMed 12673844

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Long-term Mitapivat Dosing in Subjects With Stable Sickle Cell Disease: An Extension of a Phase I Pilot Study of Mitapivat
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HPC Offered for PRESERVE Expansion
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RecruitingPhase 1
Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
Sickle Cell Disorders, Sickle Cell Disease
RecruitingPhase 4
Clinical and Biomarker Effects of Depot Medroxyprogesterone Acetate in Females With Sickle Cell Disease
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Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
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All Sickle Cell Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II Study of Simvastatin (Zocor) Therapy in Sickle Cell Disease
ClinicalTrials.gov ID: NCT00508027
Acronym / sponsor ID: 1R01FD003080-01A1
Conditions: Sickle Cell Disease
Keywords: sickle cell disease, simvastatin, statin drugs, nitric oxide donors, vascular injury
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: UCSF Benioff Children's Hospital OaklandUniversity, hospital or other
Collaborators: Department of Health and Human Services, FDA Office of Orphan Products Development
Study start: Jun 2007
Primary completion: Dec 2011 (actual)
Study completion: Dec 2011 (actual)
First posted: 27 Jul 2007 (estimated)
Results: Posted 16 Aug 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

To obtain preliminary efficacy data on the effects of oral simvastatin on plasma biomarkers of endothelial injury in patients with SCD, and
To assess the safety and tolerability of oral simvastatin in patients with SCD.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Simvastatin, Dose Escalation	Other	Drug: SimvastatinThere are no arms in this study. Simvastatin will be given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Established diagnosis of sickle cell disease (HbSS, SC or Sβ-thalassemia)
Age greater than or equal to thirteen years
Weight greater than or equal to 35 kg

Key exclusion criteria (13 listed)

Renal dysfunction (Serum Creatinine > 1.5 UNL)
Hepatic dysfunction (ALT > 2X UNL)
Pretreatment total cholesterol < 100 mg/dL or triglycerides < 30 mg/dL
Pretreatment baseline creatine kinase >1X UNL (215 U/L)
Pregnancy/lactation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SimvastatinAlso: ZocorComparison of 3 dosages of simvastatin given in a dose-escalating fashion. 20 mg, 40 mg, or 80 mg PO QD x 21 days followed by a drug taper x 4 days.	Drug	Simvastatin, Dose Escalation

Primary outcome

Change in Total Cholesterol Level
Time frame: Baseline, 21 days
Change in serum total cholesterol level after treatment with simvastatin
Change in Hemoglobin Level
Time frame: Baseline, 21 days
Change in plasma hemoglobin (Hb) level after treatment with simvastatin
Change in Serum Creatine Kinase Levels
Time frame: Baseline, 21 days
Change in serum creatine kinase (CK) levels after treatment with simvastatin
Change in Serum Alanine Transaminase (ALT) Levels
Time frame: Baseline, 21 days
Change in serum alanine transaminase (ALT) after treatment with simvastatin
Change in Serum Creatinine Levels
Time frame: Baseline, 21 days
Change in serum creatinine (Cr) levels after treatment with simvastatin

Results and safety

Results posted to the registry on 16 Aug 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Simvastatin, 3 Escalating Dose Groups	20	12

Primary outcome: Change in Total Cholesterol Level

Time frame: Baseline, 21 days. Mean (Standard Deviation). Unit: mg/dL

Measure	Simvastatin, Dose Level 1 n = 16	Simvastatin, Dose Level 2 n = 12	Simvastatin, Dose Level 3 n = 2
Value	-16 (2)	-18 (10)	-18 (4)

Primary outcome: Change in Hemoglobin Level

Time frame: Baseline, 21 days. Mean (Standard Deviation). Unit: gm/dL

Measure	Simvastatin, Dose Level 1 n = 16	Simvastatin, Dose Level 2 n = 12	Simvastatin, Dose Level 3 n = 2
Value	-0.2 (0.1)	0.1 (0.2)	-0.4 (0.1)

Primary outcome: Change in Serum Creatine Kinase Levels

Time frame: Baseline, 21 days. Mean (Standard Deviation). Unit: U/L

Measure	Simvastatin, Dose Level 1 n = 16	Simvastatin, Dose Level 2 n = 12	Simvastatin, Dose Level 3 n = 2
Value	57 (88)	20 (34)	62 (20)

Primary outcome: Change in Serum Alanine Transaminase (ALT) Levels

Time frame: Baseline, 21 days. Mean (Standard Deviation). Unit: U/L

Measure	Simvastatin, Dose Level 1 n = 16	Simvastatin, Dose Level 2 n = 12	Simvastatin, Dose Level 3 n = 2
Value	4 (3)	3 (4)	-3 (2)

Adverse events

Time frame: 39 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Simvastatin, Dose 1	1 of 20 (5%)	3 of 20 (15%)	Not reported
Simvastatin, Dose 2	1 of 20 (5%)	3 of 20 (15%)	Not reported
Simvastatin, Dose 3	0 of 2 (0%)	1 of 2 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 7149170Hebbel RP. Extracorpuscular factors in the pathogenesis of sickle cell disease. Am J Pediatr Hematol Oncol. 1982 Fall;4(3):316-9.
Background: PubMed 9169483Hebbel RP. Perspectives series: cell adhesion in vascular biology. Adhesive interactions of sickle erythrocytes with endothelium. J Clin Invest. 1997 Jun 1;99(11):2561-4. doi: 10.1172/JCI119442. No abstract available.
Background: PubMed 15280085Hebbel RP. Special issue of Microcirculation: examination of the vascular pathobiology of sickle cell anemia. Foreword. Microcirculation. 2004 Mar;11(2):99-100. No abstract available.
Background: PubMed 15001449Kaul DK, Liu XD, Choong S, Belcher JD, Vercellotti GM, Hebbel RP. Anti-inflammatory therapy ameliorates leukocyte adhesion and microvascular flow abnormalities in transgenic sickle mice. Am J Physiol Heart Circ Physiol. 2004 Jul;287(1):H293-301. doi: 10.1152/ajpheart.01150.2003. Epub 2004 Mar 4.
Background: PubMed 14704223Wood KC, Hebbel RP, Granger DN. Endothelial cell P-selectin mediates a proinflammatory and prothrombogenic phenotype in cerebral venules of sickle cell transgenic mice. Am J Physiol Heart Circ Physiol. 2004 May;286(5):H1608-14. doi: 10.1152/ajpheart.01056.2003. Epub 2004 Jan 2.
Background: PubMed 11001897Belcher JD, Marker PH, Weber JP, Hebbel RP, Vercellotti GM. Activated monocytes in sickle cell disease: potential role in the activation of vascular endothelium and vaso-occlusion. Blood. 2000 Oct 1;96(7):2451-9.
Background: PubMed 10597756Haffner SM, Alexander CM, Cook TJ, Boccuzzi SJ, Musliner TA, Pedersen TR, Kjekshus J, Pyorala K. Reduced coronary events in simvastatin-treated patients with coronary heart disease and diabetes or impaired fasting glucose levels: subgroup analyses in the Scandinavian Simvastatin Survival Study. Arch Intern Med. 1999 Dec 13-27;159(22):2661-7. doi: 10.1001/archinte.159.22.2661.
Background: PubMed 11728362Laufs U, Wassmann S, Hilgers S, Ribaudo N, Bohm M, Nickenig G. Rapid effects on vascular function after initiation and withdrawal of atorvastatin in healthy, normocholesterolemic men. Am J Cardiol. 2001 Dec 1;88(11):1306-7. doi: 10.1016/s0002-9149(01)02095-1. No abstract available.
Background: PubMed 9042813Hebbel RP, Vercellotti GM. The endothelial biology of sickle cell disease. J Lab Clin Med. 1997 Mar;129(3):288-93. doi: 10.1016/s0022-2143(97)90176-1. No abstract available.
Background: PubMed 9371854Solovey A, Lin Y, Browne P, Choong S, Wayner E, Hebbel RP. Circulating activated endothelial cells in sickle cell anemia. N Engl J Med. 1997 Nov 27;337(22):1584-90. doi: 10.1056/NEJM199711273372203.
Background: PubMed 9576754Solovey A, Gui L, Key NS, Hebbel RP. Tissue factor expression by endothelial cells in sickle cell anemia. J Clin Invest. 1998 May 1;101(9):1899-904. doi: 10.1172/JCI1932.
Background: PubMed 12579034Reiter CD, Gladwin MT. An emerging role for nitric oxide in sickle cell disease vascular homeostasis and therapy. Curr Opin Hematol. 2003 Mar;10(2):99-107. doi: 10.1097/00062752-200303000-00001.
Children's Hospital and Research Center Oakland Official WebsiteLink provided by the sponsor.
NHLBI Website - Sickle Cell DiseaseLink provided by the sponsor.
Medline Plus: Sickle Cell AnemiaLink provided by the sponsor.
CHO Library: Sickle Cell Disease InformationLink provided by the sponsor.
CHO Sickle Cell Program: National Center for Sickle Cell DiseaseLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Carolyn C Hoppe, M.D. principal investigator

UCSF Benioff Children's Hospital Oakland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Simvastatin in people with Sickle Cell Disease, run by UCSF Benioff Children's Hospital Oakland at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Total Cholesterol Level (time frame: Baseline, 21 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00508027, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.