Sickle Cell AnemiaPhase 2NCT02072668
The Effect of Rivaroxaban in Sickle Cell Disease
A Phase 2 study testing rivaroxaban in people with Sickle Cell Anemia and Sickle Cell-Beta0-Thalassemia, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The primary study hypothesis is that inhibition of factor Xa with rivaroxaban will reduce inflammation, coagulation and endothelial cell activation, and improve microvascular blood flow in patients with sickle cell disease (SCD) during the non-crisis, steady state. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sickle Cell Anemia, Sickle Cell-Beta0-Thalassemia
- What is being tested?
- rivaroxaban
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 4 Oct 2018
- Phase
- Phase 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 65 years of age; sickle cell anemia (HbSS) or sickle-beta0 (HbSβ0) thalassemia;
- serum creatinine ≤ 1.0 mg/dL men) or 1.2 mg/dL (women);
- ALT </= 2 times upper limits of normal;
- platelet count ≥ 50,000 cu/mm;
- normal baseline PT/international normalized ratio (INR) and aPTT;
- be in the non-crisis, "steady state" with no severe pain episodes during the preceding 4 weeks;
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- ability to understand the requirements of the study and be willing to give informed consent;
- women of childbearing age must be practicing an adequate method of contraception;
- and if on hydroxyurea, be on a stable dose for at least 3 months prior to enrollment.
Who cannot join
- hypersensitivity to any component of rivaroxaban;
- history of major GI bleeding or bleeding diathesis;
- baseline Hb < 5.5 gm/dL;
- history of clinically overt stroke;
- brain magnetic resonance imaging with angiography (MRI/MRA) scan with evidence of Moya Moya;
- pregnant or breastfeeding;
Show all 14Show fewer
- active liver disease or ALT > 3 times upper limit of normal;
- on chronic anticoagulant, non-steroidal anti-inflammatory (NSAID) or statin therapy;
- history of metastatic cancer;
- current alcohol abuse;
- on a chronic transfusion program or any blood transfusion in the 3 months prior to enrollment;
- ingested any investigational drugs within the past 4 weeks;
- use of CYP3A4/P-glycoprotein inducers such as carbamazepine, phenytoin, rifampin, and St John's wort;
- use of CYP3A4/P- glycoprotein inhibitors such as ketoconazole, indinavir/ritonavir, itraconazole, lopinavir/ritonavir, ritonavir, and conivaptan.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: The Effect of Factor Xa Inhibition, With Rivaroxaban, on the Pathology of Sickle Cell Disease
The primary study hypothesis is that inhibition of factor Xa with rivaroxaban will reduce inflammation, coagulation and endothelial cell activation, and improve microvascular blood flow in patients with sickle cell disease (SCD) during the non-crisis, steady state. To test this hypothesis, this study will evaluate the effects of rivaroxaban on:
- plasma markers of inflammation;
- plasma markers of endothelial activation;
- plasma markers of thrombin generation; and
- microvascular blood flow assessed using laser Doppler velocimetry (LDV) of post-occlusive reactive hyperemia (PORH).
In a cross-over design, subjects will receive rivaroxaban 20 mg/day and placebo for 4 weeks each, separated by a 2-week washout phase.
Read the detailed description
The study will consist of a Screening Phase, two Treatment Phases, a Wash-Out Phase, and a Follow-up Phase. The Screening Phase will occur within 28 days of randomization and will include informed consent, a physical examination, and complete medical history to include determination of sickle cell genotype and current medications. Clinical laboratory tests to be performed include: a Complete Blood Count (CBC) with differential and reticulocyte count; Prothrombin time(PT) / activated partial thromboplastin time (aPTT); and serum chemistries (BUN, creatinine, total and direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and LDH). A chest x-ray and MRI/MRA of the brain will also be done at Screening to rule out underlying disease.
If the patient is found through the screening process to be eligible, the 1st Treatment Phase begins. Baseline safety assessments and measurement of biomarkers are completed, then the subject is randomized to receive rivaroxaban or placebo. After 4 weeks of treatment, there is a 2-Week Wash-Out Phase. After the Wash-Out Phase, another set of baseline studies are performed and the 2nd Treatment Phase begins. For this Phase of the study, the subject "crosses over" to receive whatever treatment - rivaroxaban or placebo - that they did not receive in the 1st Treatment Phase. After taking the assigned study drug for 4 weeks, the 2nd Treatment Phase ends. The subject returns 2 weeks after the last dose of study treatment for the Follow-Up Phase, consisting of a single end-of-study visit during which safety assessments are repeated.
- Conditions
- Sickle Cell Anemia, Sickle Cell-Beta0-Thalassemia
- Being tested
- rivaroxaban, placebo
- Keywords
- sickle cell anemia, sickle cell disease, rivaroxaban, direct Xa inhibition, coagulation, anticoagulation
- Medical subject headings
- Anemia, Sickle Cell, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rivaroxabanDrug
Also called Xarelto
Subject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form OR Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form.
placeboDrug
Subject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form OR Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban for 4 wks, Placebo for 4 wks | Other | Subject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form. Receives: Drug: rivaroxaban; Drug: placebo |
| Placebo for 4 wks, rivaroxaban for 4 wks | Other | Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form. Receives: Drug: rivaroxaban; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 4 Weeks in Soluble Vascular Cell Adhesion Molecule-1 (VCAM-1)
Assay performed for soluble VCAM-1 using a commercially available enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, 4 weeks
Change From Baseline to 4 Weeks in Interleukin-6 (IL-6)
Assay performed for IL-6 using a commercially available enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, 4 weeks
Secondary outcomes (15)
Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-2
Interleukin-2 (IL-2) was measured using Luminex MAP technology at the UNC core facility
Measured: Baseline, 4 weeks
Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-8
Interleukin-8 (IL-8) was measured using Luminex MAP technology at the UNC core facility
Measured: Baseline, 4 weeks
Change From Baseline to Week 4 in Plasma Marker of Inflammation hsCRP
high sensitivity C-reactive protein (hsCRP) was measured using Luminex MAP technology at the UNC core facility.
Measured: Baseline, 4 weeks
Change From Baseline to Week 4 in Plasma Marker of Inflammation MPO
myeloperoxidase (MPO) was measured using Luminex MAP technology at the UNC core facility.
Measured: Baseline, 4 weeks
Change From Baseline to Week 4 in Plasma Marker of Inflammation TNF-a
tumor necrosis factor alpha (TNF-a) was measured using Luminex MAP technology at the UNC core facility.
Measured: Baseline, 4 weeks
Change From Baseline to Week 4 in Plasma Marker of Inflammation sPLA2
secretory phospholipase A2 (sPLA2) was measured using Luminex MAP technology at the UNC core facility
Measured: Baseline, 4 weeks
Change From Baseline to Week 4 in Marker of Endothelial Cell (EC) Activation sICAM
levels of soluble intracellular adhesion molecule (sICAM) were measured using a commercially available ELISA
Measured: Baseline, 4 weeks
Change From Baseline to Week 4 in TH1
Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: time to half before hyperemia (TH1)
Measured: Baseline, 4 weeks
Change From Baseline to Week 4 in TM
Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: time to max (TM)
Measured: Baseline, 4 weeks
Change From Baseline to Week 4 in AH
Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: hyperemia area (AH)
Measured: Baseline, 4 weeks
Change in Ratio From Baseline to Week 4 in AH/AO
Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variables measured: hyperemia area (AH) and occlusion area (AO)
Measured: Baseline, 4 weeks
Change From Baseline to Week 4 in PF
Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: peak flow (PF)
Measured: Baseline, 4 weeks
Change From Baseline to Week 4 in RF
Microvascular blood flow was measured using laser doppler velocimetry (LDV) assessments of post-occlusive reactive hyperemia (PORH). This was accomplished using the Perimed PF5001 Velocitometer (Stockholm, Sweden). Variable measured: rest flow (RF)
Measured: Baseline, 4 weeks
Change From Baseline to Week 4 in TAT
Assay for thrombin antithrombin (TAT) complexes performed using commercially available enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, 4 weeks
Change From Baseline to Week 4 in D-Dimer
Assay for D--dimer is performed using commercially available enzyme-linked immunosorbent assay (ELISA).
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completion4 Oct 2018
- Study completion4 Oct 2018
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 (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell AnemiaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Kenneth I Ataga, MBBS, Principal investigator, University of North Carolina, Chapel HillNigel Key, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072668
- Sponsor's protocol ID
- 12-2607
- Other IDs
- U01HL117659-01
- Status last verified
- Mar 2020
- First submitted
- 24 Feb 2014
- Last updated
- 13 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ataga KI, Elsherif L, Wichlan D, Wogu AF, Matsui N, Pawlinski R, Cai J, Key NS. A pilot study of the effect of rivaroxaban in sickle cell anemia. Transfusion. 2021 Jun;61(6):1694-1698. doi: 10.1111/trf.16343. Epub 2021 Mar 4.
PubMed 33660875
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Factor Xa Inhibition, With Rivaroxaban, on the Pathology of Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT02072668
- Acronym / sponsor ID
- 12-2607
- Conditions
- Sickle Cell Anemia, Sickle Cell-Beta0-Thalassemia
- Keywords
- sickle cell anemia, sickle cell disease, rivaroxaban, direct Xa inhibition, coagulation, anticoagulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Feb 2014
- Primary completion
- 4 Oct 2018 (actual)
- Study completion
- 4 Oct 2018 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Posted 13 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary study hypothesis is that inhibition of factor Xa with rivaroxaban will reduce inflammation, coagulation and endothelial cell activation, and improve microvascular blood flow in patients with sickle cell disease (SCD) during the non-crisis, steady state. To test this hypothesis, this study will evaluate the effects of rivaroxaban on:
- plasma markers of inflammation;
- plasma markers of endothelial activation;
- plasma markers of thrombin generation; and
- microvascular blood flow assessed using laser Doppler velocimetry (LDV) of post-occlusive reactive hyperemia (PORH).
In a cross-over design, subjects will receive rivaroxaban 20 mg/day and placebo for 4 weeks each, separated by a 2-week washout phase.
Detailed description
The study will consist of a Screening Phase, two Treatment Phases, a Wash-Out Phase, and a Follow-up Phase. The Screening Phase will occur within 28 days of randomization and will include informed consent, a physical examination, and complete medical history to include determination of sickle cell genotype and current medications. Clinical laboratory tests to be performed include: a Complete Blood Count (CBC) with differential and reticulocyte count; Prothrombin time(PT) / activated partial thromboplastin time (aPTT); and serum chemistries (BUN, creatinine, total and direct bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and LDH). A chest x-ray and MRI/MRA of the brain will also be done at Screening to rule out underlying disease.
If the patient is found through the screening process to be eligible, the 1st Treatment Phase begins. Baseline safety assessments and measurement of biomarkers are completed, then the subject is randomized to receive rivaroxaban or placebo. After 4 weeks of treatment, there is a 2-Week Wash-Out Phase. After the Wash-Out Phase, another set of baseline studies are performed and the 2nd Treatment Phase begins. For this Phase of the study, the subject "crosses over" to receive whatever treatment - rivaroxaban or placebo - that they did not receive in the 1st Treatment Phase. After taking the assigned study drug for 4 weeks, the 2nd Treatment Phase ends. The subject returns 2 weeks after the last dose of study treatment for the Follow-Up Phase, consisting of a single end-of-study visit during which safety assessments are repeated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban for 4 wks, Placebo for 4 wks | Other | Drug: rivaroxaban, Drug: placeboSubject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form. |
| Placebo for 4 wks, rivaroxaban for 4 wks | Other | Drug: rivaroxaban, Drug: placeboSubject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 65 years of age; sickle cell anemia (HbSS) or sickle-beta0 (HbSβ0) thalassemia;
- serum creatinine ≤ 1.0 mg/dL men) or 1.2 mg/dL (women);
- ALT </= 2 times upper limits of normal;
- platelet count ≥ 50,000 cu/mm;
- normal baseline PT/international normalized ratio (INR) and aPTT;
Key exclusion criteria (14 listed)
- hypersensitivity to any component of rivaroxaban;
- history of major GI bleeding or bleeding diathesis;
- baseline Hb < 5.5 gm/dL;
- history of clinically overt stroke;
- brain magnetic resonance imaging with angiography (MRI/MRA) scan with evidence of Moya Moya;
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 |
|---|---|---|
| rivaroxabanAlso: XareltoSubject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form OR Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form. | Drug | Placebo for 4 wks, rivaroxaban for 4 wks, Rivaroxaban for 4 wks, Placebo for 4 wks |
| placeboSubject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form OR Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form. | Drug | Placebo for 4 wks, rivaroxaban for 4 wks, Rivaroxaban for 4 wks, Placebo for 4 wks |
Primary outcome
Change From Baseline to 4 Weeks in Soluble Vascular Cell Adhesion Molecule-1 (VCAM-1)
Time frame: Baseline, 4 weeks
Assay performed for soluble VCAM-1 using a commercially available enzyme-linked immunosorbent assay (ELISA).
Change From Baseline to 4 Weeks in Interleukin-6 (IL-6)
Time frame: Baseline, 4 weeks
Assay performed for IL-6 using a commercially available enzyme-linked immunosorbent assay (ELISA).
15 secondary outcomes
Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-2
Time frame: Baseline, 4 weeks
Change From Baseline to Week 4 in the Plasma Marker of Inflammation IL-8
Time frame: Baseline, 4 weeks
Change From Baseline to Week 4 in Plasma Marker of Inflammation hsCRP
Time frame: Baseline, 4 weeks
Change From Baseline to Week 4 in Plasma Marker of Inflammation MPO
Time frame: Baseline, 4 weeks
Change From Baseline to Week 4 in Plasma Marker of Inflammation TNF-a
Time frame: Baseline, 4 weeks
Change From Baseline to Week 4 in Plasma Marker of Inflammation sPLA2
Time frame: Baseline, 4 weeks
Change From Baseline to Week 4 in Marker of Endothelial Cell (EC) Activation sICAM
Time frame: Baseline, 4 weeks
Change From Baseline to Week 4 in TH1
Time frame: Baseline, 4 weeks
Change From Baseline to Week 4 in TM
Time frame: Baseline, 4 weeks
Change From Baseline to Week 4 in AH
Time frame: Baseline, 4 weeks
Change in Ratio From Baseline to Week 4 in AH/AO
Time frame: Baseline, 4 weeks
Change From Baseline to Week 4 in PF
Time frame: Baseline, 4 weeks
Change From Baseline to Week 4 in RF
Time frame: Baseline, 4 weeks
Change From Baseline to Week 4 in TAT
Time frame: Baseline, 4 weeks
Change From Baseline to Week 4 in D-Dimer
Time frame: Baseline, 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33660875Ataga KI, Elsherif L, Wichlan D, Wogu AF, Matsui N, Pawlinski R, Cai J, Key NS. A pilot study of the effect of rivaroxaban in sickle cell anemia. Transfusion. 2021 Jun;61(6):1694-1698. doi: 10.1111/trf.16343. Epub 2021 Mar 4.
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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.
Kenneth I Ataga, MBBS principal investigator
University of North Carolina, Chapel Hill
Nigel Key, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing rivaroxaban in people with Sickle Cell Anemia and Sickle Cell-Beta0-Thalassemia, run by University of North Carolina, Chapel Hill 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 9 inclusion and 14 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 13 Apr 2020. 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 phase mean?
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 13 Apr 2020). 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 From Baseline to 4 Weeks in Soluble Vascular Cell Adhesion Molecule-1 (VCAM-1) (time frame: Baseline, 4 weeks). The study lists 2 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 NCT02072668, which also lists 1 linked publication.
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 13 Apr 2020; AzTrials last refreshed its copy on 7 Nov 2026.