Sickle Cell AnemiaPhase 3TWiTCHNCT01425307
Transcranial Doppler (TCD) With Transfusions Changing to Hydroxyurea
A Phase 3 study testing Hydroxyurea in people with Sickle Cell Anemia, run by Children's Hospital Medical Center, Cincinnati.
Trial summary
The primary goal of the Phase III TWiTCH trial is to compare 24 months of alternative therapy (hydroxyurea) to standard therapy (transfusions) for pediatric subjects with sickle cell anemia and abnormally high (≥200 cm/sec) Transcranial Doppler (TCD) velocities, who currently receive chronic transfusions to reduce the… Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Sickle Cell Anemia
- What is being tested?
- Hydroxyurea
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Nov 2015
- Phase
- Phase 3
- 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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric subjects with severe forms of sickle cell anemia (HbSS, HbSβ0 thalassemia,HbSOArab)
- Age range of 4.0-15.99 years, inclusive, at the time of enrollment
- Documented index (pre-treatment) abnormally high TCD Velocity by Transcranial Doppler ultrasonography. An abnormally high index TCD is defined as TCD V greater than or equal to 200 cm/sec, or abnormally high TCDi V greater than or equal to185cm/sec, or TCD maximum V greater than or equal to 250 cm/sec.
- At least 12 months of chronic monthly erythrocyte transfusions since the index abnormal TCD examination
- Adequate monthly erythrocyte transfusions with average HbS less than or equal to 45% (the upper limit of the established academic community standard) for the past 6 months before enrollment
- Parent or guardian willing and able to provide informed consent with verbal or written assent from the child
- Ability to comply with study related treatments, evaluations, and follow-up
Who cannot join
- Completed overt clinical stroke or TIA
- Inability to obtain TCD velocities due to anatomical abnormalities such as a) Inadequate bone windows b) Previous revascularization procedures (e.g., EDAS)
- Known severe vasculopathy or moya-moya disease on brain MRA
- Inability to receive or tolerate chronic red blood cell (RBC) transfusion therapy, due to any of the following: a) Multiple RBC alloantibodies making cross-matching difficult or impossible b) RBC autoantibodies making cross-matching difficult or impossible c) Religious objection to transfusions that preclude their chronic use d) Non-compliance with transfusions over the past 6 months before enrollment (temporary exclusion)
- Inability to take or tolerate daily oral hydroxyurea, including a) Known allergy to hydroxyurea therapy b) Positive serology to HIV infection c) Malignancy d) Current lactation e) Previous stem cell transplant or other myelosuppressive therapy
- Clinical and laboratory evidence of hypersplenism (temporary exclusions): a) Palpable splenomegaly greater than 5cm below the left costal margin AND b) Transfusion requirement greater than 250 mL/kg over the previous 12 months
Show all 13Show fewer
- Abnormal laboratory values at initial evaluation (temporary exclusions): a) Pre-transfusion hemoglobin concentration less than 8.0 gm/dL b) WBC count less than 3.0 x 10^9/L c) Absolute neutrophil count (ANC) less than 1.5 x 10^9/L d) Platelet count less than 100 x 10^9/L e) Serum creatinine more than twice the upper limit for age OR greater than or equal to 1.0 mg/dL
- Current participation in other therapeutic clinical trials
- Current use of other therapeutic agents for sickle cell disease (e.g., arginine, decitabine, magnesium). Subjects must have been off hydroxyurea for at least 3- months prior to enrollment.
- Any condition or chronic illness, such as a positive tuberculin (PPD) test, which in the opinion of the CI makes participation ill-advised.
- Inability or unwillingness to complete required screening and exit studies, including TCD ultrasonography, brain MRI/MRA, liver MRI and blood tests.
- A sibling enrolled in TWiTCH
- Pregnancy or unwillingness to use a medically acceptable form of contraception if sexually active (male OR female).
About this study
Official title: TCD With Transfusions Changing to Hydroxyurea (TWiTCH): A Phase III Randomized Trial to Compare Standard Therapy (Erythrocyte Transfusions) With Alternative Therapy (Hydroxyurea) for the Maintenance of Lowered TCD Velocities in Pediatric Subjects With Sickle Cell Anemia and Abnormal Pre-treatment TCD Velocities
The primary goal of the Phase III TWiTCH trial is to compare 24 months of alternative therapy (hydroxyurea) to standard therapy (transfusions) for pediatric subjects with sickle cell anemia and abnormally high (≥200 cm/sec) Transcranial Doppler (TCD) velocities, who currently receive chronic transfusions to reduce the risk of primary stroke. For the alternative treatment regimen (hydroxyurea) to be declared non-inferior to the standard treatment regimen (transfusions), after adjusting for baseline differences, the hydroxyurea-treated group must have a mean TCD velocity similar to that observed with transfusion prophylaxis.
Read the detailed description
Despite the clear results of the STOP and the follow-up STOP II trials, the use of chronic erythrocyte transfusions for primary stroke prevention in children with Sickle Cell Anemia (SCA) remains controversial for many practicing hematologists, as well as for patients and families. Transfusions have proven clinical efficacy in preventing first stroke in children with SCA and abnormal TCD velocities, but their indefinite use may still be difficult to justifY.
The risk of transfusion acquired iron overload is now recognized as a serious consequence of chronic erythrocyte transfusions in children with SCA. After one to two years of monthly transfusions, virtually every patient will have excess hepatic iron deposition that warrants intervention with chelation therapy. The effectiveness of iron chelation has not yet been realized, despite the availability of the oral chelator deferasirox (Exjade®), due to its lack of palatability and increasing recognition of serious drug-related toxicities including renal and hepatic dysfunction. Simply put, indefinite erythrocyte transfusions cannot be viewed as adequate and acceptable long-term therapy for primary stroke prevention in SCA. There is an urgent need to develop an equivalent effective alternative therapy for the prevention of primary stroke in children with SCA, specifically one that better manages iron overload and improves quality of life.
- Conditions
- Sickle Cell Anemia
- Being tested
- Hydroxyurea
- Keywords
- Phase III, Sickle cell anemia, Abnormally high Transcranial Doppler velocities., Reduce risk of primary stroke, Pediatric patients, Chelation therapy
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydroxyureaDrug
Also called Hydroxycarbamide, Hydrea, Droxia
Capsules (300 mg, 400 mg, or 500 mg) taken once daily liquid formulation (100 mg/mL)
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy | No intervention | Standard Therapy of monthly transfusions |
| Treatment Arm | Experimental | Hydroxyurea will be provided as capsules or liquid Receives: Drug: Hydroxyurea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side
The primary endpoint for the TWiTCH trial was the difference between the treatment groups of the maximum TCD TAMV on the index side, calculated from a mixed model. The index side is the side with the higher mean (averaged over baseline evaluations) of the maximum (over arteries on that side) TCD time-averaged velocity. Values of the TAMV on the index site were obtained at clinic visits during baseline and during the treatment period.
Measured: Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).
Secondary outcomes (14)
TCD Time-averaged Mean Velocity on the Non-index Side
This secondary endpoint for the TWiTCH trial will be maximum TCD time-averaged mean velocity on the non-index side. The non-index side is the side with the lower mean (averaged over baseline evaluations) of the maximum (over arteries on that side) TCD time-averaged velocity. Values of the secondary endpoint will be obtained at clinic visits during baseline and during the 24-month treatment period.
Measured: 24 months
Primary Stroke Events
This secondary outcome measure will compare standard to alternative therapy for primary stroke events (a) primary ischemic stroke; b) primary hemorrhagic stroke
Measured: 24 months
Non-stroke Neurological Events
This secondary objective will compare standard to alternative treatment for the incidence of non-stroke neurological events. Data for this outcome will be collected through entry and exit neurological exams.
Measured: 24 months
Change of Baseline in Hepatic Iron Overload as Assessed by Serum Ferritin
This secondary objective will compare standard to alternative therapy for hepatic iron overload.
Measured: Baseline and 24 months
Effects on Quality of Life
Standard Quality of Life measure will be taken during specific time points as well as one newly developed Sickle Cell Disease-specific test.
Measured: 24 months
Functional Status
This outcome will be measured using Barthel Index testing at the beginning, middle, and end of the treatment period.
Measured: 24 months
Neuropsychological Decline
This outcome will be measured using standardized neurocognitive tests at baseline and exit.
Measured: 24 months
Growth and Development
This outcome will be measured by capturing height and weight monthly and conducting an annual pubertal assessment.
Measured: 24 months
Number of Participants With Transfusion Events
This outcome will be recorded on every interval visit form through questions asking whether there have been transfusion complications. Any complication higher than a CTCAE grade 2 event will be reported as a SAE.
Measured: 24 months
Number of Participants With Hydroxyurea Toxicities
This measure will be performed on a monthly basis throughout the trial by recording the CBC and retic count.
Measured: 24 Months
Number of Participants With Phlebotomy Complications
This outcome will be recorded on every interval visit form through questions asking whether there have been phlebotomy complications. Any complication higher than a CTCAE grade 2 event will be reported as a SAE.
Measured: 24 months
Number of Participants With Liver MRI Complications
This outcome will be recorded through questions asking whether there have been Liver MRI complications at baseline, middle, and end of treatment. Any complication higher than a CTCAE grade 2 event will be reported as a SAE.
Measured: 24 months
Number of Participants With Serious Adverse Events
Measured: 24 Months
Change of Baseline in Hepatic Iron Overload as Assessed by Liver Iron Concentration
This secondary objective will compare standard to alternative therapy for hepatic iron overload.
Measured: Baseline and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2015
- Study completionNov 2015
Why it stopped: The study was stopped early due to successfully meeting the primary endpoint
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.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Boston Children's Hospital, University of Texas Southwestern Medical Center, Children's Healthcare of Atlanta, Children's Hospital of Philadelphia, The Hospital for Sick Children, Children's National Research Institute, Columbia University, St. Jude Children's Research Hospital, University Hospitals Cleveland Medical Center, University of South Alabama, Medical University of South Carolina, University of Alabama at Birmingham, University of Miami, University of Mississippi Medical Center, Wayne State University, Children's Hospital of The King's Daughters, Nemours Children's Clinic, Duke University, East Carolina University, Children's Hospitals and Clinics of Minnesota, Ann & Robert H Lurie Children's Hospital of Chicago, Baylor College of Medicine, State University of New York - Downstate Medical Center, Steven and Alexandra Cohen Children's Medical Center
- Responsible party
- Sponsor
- Investigators
- Russell E. Ware, MD, PhD, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01425307
- Sponsor's protocol ID
- H-28572 TWiTCH
- Other IDs
- R01HL095647
- Acronym
- TWiTCH
- Status last verified
- May 2017
- First submitted
- 19 Aug 2011
- Last updated
- 22 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ware RE, Davis BR, Schultz WH, Brown RC, Aygun B, Sarnaik S, Odame I, Fuh B, George A, Owen W, Luchtman-Jones L, Rogers ZR, Hilliard L, Gauger C, Piccone C, Lee MT, Kwiatkowski JL, Jackson S, Miller ST, Roberts C, Heeney MM, Kalfa TA, Nelson S, Imran H, Nottage K, Alvarez O, Rhodes M, Thompson AA, Rothman JA, Helton KJ, Roberts D, Coleman J, Bonner MJ, Kutlar A, Patel N, Wood J, Piller L, Wei P, Luden J, Mortier NA, Stuber SE, Luban NLC, Cohen AR, Pressel S, Adams RJ. Hydroxycarbamide versus chronic transfusion for maintenance of transcranial doppler flow velocities in children with sickle cell anaemia-TCD With Transfusions Changing to Hydroxyurea (TWiTCH): a multicentre, open-label, phase 3, non-inferiority trial. Lancet. 2016 Feb 13;387(10019):661-670. doi: 10.1016/S0140-6736(15)01041-7. Epub 2015 Dec 6.
PubMed 26670617
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TCD With Transfusions Changing to Hydroxyurea (TWiTCH): A Phase III Randomized Trial to Compare Standard Therapy (Erythrocyte Transfusions) With Alternative Therapy (Hydroxyurea) for the Maintenance of Lowered TCD Velocities in Pediatric Subjects With Sickle Cell Anemia and Abnormal Pre-treatment TCD Velocities
- ClinicalTrials.gov ID
- NCT01425307
- Acronym / sponsor ID
- TWiTCH / H-28572 TWiTCH
- Conditions
- Sickle Cell Anemia
- Keywords
- Phase III, Sickle cell anemia, Abnormally high Transcranial Doppler velocities., Reduce risk of primary stroke, Pediatric patients, Chelation therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped early due to successfully meeting the primary endpoint
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Boston Children's Hospital, University of Texas Southwestern Medical Center, Children's Healthcare of Atlanta, Children's Hospital of Philadelphia, The Hospital for Sick Children, Children's National Research Institute, Columbia University, St. Jude Children's Research Hospital, University Hospitals Cleveland Medical Center, University of South Alabama, Medical University of South Carolina, University of Alabama at Birmingham, University of Miami, University of Mississippi Medical Center, Wayne State University, Children's Hospital of The King's Daughters, Nemours Children's Clinic, Duke University, East Carolina University, Children's Hospitals and Clinics of Minnesota, Ann & Robert H Lurie Children's Hospital of Chicago, Baylor College of Medicine, State University of New York - Downstate Medical Center, Steven and Alexandra Cohen Children's Medical Center
- Study start
- Aug 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 30 Aug 2011 (estimated)
- Results
- Posted 11 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of the Phase III TWiTCH trial is to compare 24 months of alternative therapy (hydroxyurea) to standard therapy (transfusions) for pediatric subjects with sickle cell anemia and abnormally high (≥200 cm/sec) Transcranial Doppler (TCD) velocities, who currently receive chronic transfusions to reduce the risk of primary stroke. For the alternative treatment regimen (hydroxyurea) to be declared non-inferior to the standard treatment regimen (transfusions), after adjusting for baseline differences, the hydroxyurea-treated group must have a mean TCD velocity similar to that observed with transfusion prophylaxis.
Detailed description
Despite the clear results of the STOP and the follow-up STOP II trials, the use of chronic erythrocyte transfusions for primary stroke prevention in children with Sickle Cell Anemia (SCA) remains controversial for many practicing hematologists, as well as for patients and families. Transfusions have proven clinical efficacy in preventing first stroke in children with SCA and abnormal TCD velocities, but their indefinite use may still be difficult to justifY.
The risk of transfusion acquired iron overload is now recognized as a serious consequence of chronic erythrocyte transfusions in children with SCA. After one to two years of monthly transfusions, virtually every patient will have excess hepatic iron deposition that warrants intervention with chelation therapy. The effectiveness of iron chelation has not yet been realized, despite the availability of the oral chelator deferasirox (Exjade®), due to its lack of palatability and increasing recognition of serious drug-related toxicities including renal and hepatic dysfunction. Simply put, indefinite erythrocyte transfusions cannot be viewed as adequate and acceptable long-term therapy for primary stroke prevention in SCA. There is an urgent need to develop an equivalent effective alternative therapy for the prevention of primary stroke in children with SCA, specifically one that better manages iron overload and improves quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy | No intervention | –Standard Therapy of monthly transfusions |
| Treatment Arm | Experimental | Drug: HydroxyureaHydroxyurea will be provided as capsules or liquid |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Pediatric subjects with severe forms of sickle cell anemia (HbSS, HbSβ0 thalassemia,HbSOArab)
- Age range of 4.0-15.99 years, inclusive, at the time of enrollment
- Documented index (pre-treatment) abnormally high TCD Velocity by Transcranial Doppler ultrasonography. An abnormally high index TCD is defined as TCD V greater than or equal to 200 cm/sec, or abnormally high TCDi V greater than or equal to185cm/sec, or TCD maximum V greater than or equal to 250 cm/sec.
- At least 12 months of chronic monthly erythrocyte transfusions since the index abnormal TCD examination
- Adequate monthly erythrocyte transfusions with average HbS less than or equal to 45% (the upper limit of the established academic community standard) for the past 6 months before enrollment
Key exclusion criteria (13 listed)
- Completed overt clinical stroke or TIA
- Inability to obtain TCD velocities due to anatomical abnormalities such as a) Inadequate bone windows b) Previous revascularization procedures (e.g., EDAS)
- Known severe vasculopathy or moya-moya disease on brain MRA
- Inability to receive or tolerate chronic red blood cell (RBC) transfusion therapy, due to any of the following: a) Multiple RBC alloantibodies making cross-matching difficult or impossible b) RBC autoantibodies making cross-matching difficult or impossible c) Religious objection to transfusions that preclude their chronic use d) Non-compliance with transfusions over the past 6 months before enrollment (temporary exclusion)
- Inability to take or tolerate daily oral hydroxyurea, including a) Known allergy to hydroxyurea therapy b) Positive serology to HIV infection c) Malignancy d) Current lactation e) Previous stem cell transplant or other myelosuppressive therapy
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 |
|---|---|---|
| HydroxyureaAlso: Hydroxycarbamide, Hydrea, DroxiaCapsules (300 mg, 400 mg, or 500 mg) taken once daily liquid formulation (100 mg/mL) | Drug | Treatment Arm |
Primary outcome
Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side
Time frame: Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).
The primary endpoint for the TWiTCH trial was the difference between the treatment groups of the maximum TCD TAMV on the index side, calculated from a mixed model. The index side is the side with the higher mean (averaged over baseline evaluations) of the maximum (over arteries on that side) TCD time-averaged velocity. Values of the TAMV on the index site were obtained at clinic visits during baseline and during the treatment period.
14 secondary outcomes
TCD Time-averaged Mean Velocity on the Non-index Side
Time frame: 24 months
Primary Stroke Events
Time frame: 24 months
Non-stroke Neurological Events
Time frame: 24 months
Change of Baseline in Hepatic Iron Overload as Assessed by Serum Ferritin
Time frame: Baseline and 24 months
Effects on Quality of Life
Time frame: 24 months
Functional Status
Time frame: 24 months
Neuropsychological Decline
Time frame: 24 months
Growth and Development
Time frame: 24 months
Number of Participants With Transfusion Events
Time frame: 24 months
Number of Participants With Hydroxyurea Toxicities
Time frame: 24 Months
Number of Participants With Phlebotomy Complications
Time frame: 24 months
Number of Participants With Liver MRI Complications
Time frame: 24 months
Number of Participants With Serious Adverse Events
Time frame: 24 Months
Change of Baseline in Hepatic Iron Overload as Assessed by Liver Iron Concentration
Time frame: Baseline and 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26670617Ware RE, Davis BR, Schultz WH, Brown RC, Aygun B, Sarnaik S, Odame I, Fuh B, George A, Owen W, Luchtman-Jones L, Rogers ZR, Hilliard L, Gauger C, Piccone C, Lee MT, Kwiatkowski JL, Jackson S, Miller ST, Roberts C, Heeney MM, Kalfa TA, Nelson S, Imran H, Nottage K, Alvarez O, Rhodes M, Thompson AA, Rothman JA, Helton KJ, Roberts D, Coleman J, Bonner MJ, Kutlar A, Patel N, Wood J, Piller L, Wei P, Luden J, Mortier NA, Stuber SE, Luban NLC, Cohen AR, Pressel S, Adams RJ. Hydroxycarbamide versus chronic transfusion for maintenance of transcranial doppler flow velocities in children with sickle cell anaemia-TCD With Transfusions Changing to Hydroxyurea (TWiTCH): a multicentre, open-label, phase 3, non-inferiority trial. Lancet. 2016 Feb 13;387(10019):661-670. doi: 10.1016/S0140-6736(15)01041-7. Epub 2015 Dec 6.
- Individual participant dataSharing planned: No
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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.
Russell E. Ware, MD, PhD principal investigator
Children's Hospital Medical Center, Cincinnati
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxyurea in people with Sickle Cell Anemia, run by Children's Hospital Medical Center, Cincinnati.
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 7 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: stopped early, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 11 Apr 2017). 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?
Difference in TCD Time-averaged Mean Velocity (TAMV) on the Index Side (time frame: Since the study was terminated early, time frame is from beginning of treatment until end of treatment (up to 24 Months).). 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 NCT01425307, 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 22 Jul 2020.