MalariaPhase 1/2PEBS-POC1NCT01605786
Trial for Malaria Vaccine Candidate, PfPEBS (P. Falciparum Pre-Erythrocytic and Blood Stage)
A Phase 1/2 study testing Lyophilised PEBS synthetic protein (PfPEBS) and Rehydragel™ HPA in people with Malaria, run by Vac4All at 1 site in Switzerland.
Trial summary
This study intends to test the hypothesis that the malaria antigen PfPEBS, manufactured as a synthetic protein and adjuvanted with aluminium hydroxide will be well-tolerated and immunogenic (Phase 1), functionally active against the erythrocytic stages (Phase 1) and efficacious (Phase 2) against the pre-erythrocytic… Read more about this study
- Who is it for?
- Ages 18 to 44 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Lyophilised PEBS synthetic protein (PfPEBS) and Rehydragel™ HPA
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2012to Aug 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 44 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female age > 18 and < 45 years
- Good general health based on history, physical en laboratory examination
- Available for and willingness to undergo a P. falciparum sporozoite infected mosquito challenge following the immunization course
- Resident in or near Lausanne for the duration of the study having 24h access to a mobile telephone
- Willingness to stay in special accommodation (hotel or equivalent) from day 5 up to one day after parasite positivity , or up to day 15 post EHMI
- Agreement to refrain from blood donation during the course of the study and afterwards
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- Negative pregnancy test and the use of effective contraception during the whole study period if deemed appropriate
- Willingness to undergo an HIV test and other serologies
- Willingness to allow investigators to notify their general practitioner, if any, of participation in this trial
- Willingness to allow investigators to request medical information, relevant for participation in this trial, from their general practitioner, if any
- Written informed consent following proper understanding of the meaning and procedures of the Phase I and IIa parts of the trial
- Agreement to inform study doctor and to release medical information concerning contra-indications for participation in the study
- Willingness to undergo screening for drugs such as amphetamines, opiates and cocaine
Who cannot join
- Any history of malaria
- Known exposure to malaria in the previous 6 months, defined as a visit to a malaria endemic region. For practical purposes, all regions for which malaria chemoprophylaxis is advised by travel clinic are considered malaria endemic
- Planned to travel to endemic malaria areas during the study period
- Prior administration of an investigational malaria vaccine
- Administration of a vaccine or gammaglobulin not foreseen by the clinical trial protocol within 30 days prior to the first immunization and up to six months after the last immunization.
- Participation in any other clinical trial within 90 days prior to the onset of the trial or more than four clinical trials in the past year
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- The use of chronic medication (defined as more than 14 days), especially immunosuppressive agents or antibiotics during the study period
- The use of chronic immunosuppressive drugs or other immune modifying drugs within three months of vaccination (inhaled and topical corticosteroids are allowed)
- Positive serological tests for P. falciparum (PEBS) ELISA and/or a positive P. falciparum whole parasite ELISA
- Known hypersensitivity to vaccine components
- History of severe reactions or allergy to mosquito bites
- Contra indications to Malarone® including treatment taken by the volunteers that interfere with Malarone® (e.g. concurrent use of medicines that prolong QT interval)
- History of allergic disease to or reactions likely to be exacerbated by any component of the vaccine
- Any confirmed or suspected immunosuppressive or immunodeficiency condition, including asplenia.
- History of diabetes mellitus or cancer (except basal cell carcinoma of the skin)
- History of >2 hospitalisations for invasive bacterial infections
- Symptoms, physical signs and laboratory values suggestive of systemic disorders, including renal, hepatic, cardiovascular, pulmonary, skin, immunodeficiency, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers
- An estimated, ten year risk of fatal cardiovascular disease of ≥5%, as estimated by the Systematic Coronary Risk Evaluation (SCORE) system.
- History of arrhythmia or prolonged QT interval or other cardiac disease
- Positive history for cardiac disease in the 1st and 2nd degree relative < 50 years old
- Clinically significant abnormalities in electrocardiogram (ECG) at screening
- Body Mass Index < 18 kg/m2 or > 32 kg/m2
- Blood pressure > 150/90 in two measurements
- Seropositive for HIV, HBV or HCV
- Any clinically significant deviation from the normal range in biochemistry or haematology blood tests or in urine analysis.
- Volunteers unable to be closely followed for social, geographic or psychological reasons
- Previous history of drug or addiction to alcohol abuse interfering with normal social function during a period of one year prior to enrolment in the study
- Having not reached 10 correct responses to the knowledge questionnaire
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
Blaise Genton, MD
Reza Chakour, MD
About this study
Official title: Phase I and IIa Trial for Assessment of Safety, Immunogenicity (Phase Ia) and Efficacy (Phase IIa) Against Sporozoite Challenge of P. Falciparum Pre-Erythrocytic and Blood Stage (PfPEBS-LSP) Malaria Vaccine Candidate
This study intends to test the hypothesis that the malaria antigen PfPEBS, manufactured as a synthetic protein and adjuvanted with aluminium hydroxide will be well-tolerated and immunogenic (Phase 1), functionally active against the erythrocytic stages (Phase 1) and efficacious (Phase 2) against the pre-erythrocytic stages in protecting against an artificial malaria challenge using Pf sporozoites in a healthy adult population.
Read the detailed description
The study will enroll 36 healthy adult subjects (18-45 years) and randomize them in a double-blind manner into 3 arms of 12 subjects each; 2 of the arms will receive either 5μg or 30μg, both adjuvanted with aluminium hydroxide, given as a 2-dose schedule with a 28 day interval. The third arm of 12 subjects will act as controls, and they will receive aluminium hydroxide only injections.
If the safety and immunogenicity results permit, the subjects will be challenged with live mosquito challenge delivering P falciparum sporozoites to assess pre-erythrocytic vaccine efficacy.
The PfPEBS molecule has been found to have in vivo and in vitro functional activity against the two stages that are clinically significant for malaria namely the pre-erythrocytic stages (sporozoite and liver stages) and the erythrocytic stages.
The formulation is a simple combination of a synthetic protein of 131 amino acids adjuvanted with aluminum hydroxide, the adjuvant with the widest safety records.
The combined Phase 1/2a study is designed in order to achieve 3 co-primary objectives
- Phase 1: To demonstrate safety and tolerability
- Phase 1: To measure the activity against the asexual blood stage of the parasite which is only indirectly estimated by the functional activity of elicited antibodies in ADCI under in-vitro conditions
- Phase 2: To demonstrate efficacy against liver stages by measuring the proportion of subject that are protected following a live sporozoite challenge.
The mechanisms of defenses differ for "liver stages" and "erythrocytic stages". Defenses against "liver stages" are strongly related to the secretion of interferon γ by CD4+Th1 cells, whereas for blood stages the defences depend on antibodies.
Preliminary studies have demonstrated that low antigen doses such as 5 or 2μg produce strong CD4+Th1- interferon γ secreting cells with low antibody titers, whereas higher antigen doses such as 30 or 50μg induce lower CD4 Th1 cell response and markedly higher antibody responses.
Therefore the choice of the two dose ranges for the Pf-PEBS clinical trial protocol is aimed at testing the two main efficacy objectives, one against "liver stages" with a low dose, the other against "the blood stages" with the higher dose.
The Sponsor for the two Phases is Vac4all. The funder for the Phase Ia is the EMVDA programme of the European Commission. The funder for the Phase IIa is Vac4all
- Conditions
- Malaria
- Being tested
- Lyophilised PEBS synthetic protein (PfPEBS), Rehydragel™ HPA
- Keywords
- Malaria, Plasmodium falciparum, vaccine, ADCI, sporozoite challenge, pre-erythrocytic, erythrocytic
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lyophilised PEBS synthetic protein (PfPEBS)Biological
PfPEBS, is a synthetic polypeptide corresponding to amino acids 3112 to 3244 (131 aa) from the Pf 11.1 antigen in 3D7 parasite sequence. It is presented as lyophilised product in multi-dose vials (containing 105 μg for 3 doses of 30 μg ), looking like amorphous white powder. The vaccine is produced by SYNPROSIS in France.
The 5μg dose vaccine will be formulated extemporaneously in aluminium hydroxide adjuvant and given as a 2-dose schedule with a 28 day interval.
Lyophilised PEBS synthetic protein (PfPEBS)Biological
PfPEBS-LSP, is a synthetic polypeptide corresponding to amino acids 3112 to 3244 (131aa) from the Pf 11.1 antigen in 3D7 parasite sequence. It is presented as lyophilised product in multi-dose vials (containing 105 μg for 3 doses of 30 μg ), looking like amorphous white powder. The vaccine is produced by SYNPROSIS in France.
The 30 μg dose vaccine will be formulated extemporaneously in aluminium hydroxide adjuvant and given as a 2-dose schedule with a 28 day interval.
Rehydragel™ HPAOther
Aluminium hydroxide adjuvant is being used as the adjuvant for the vaccine and will be used as the comparator in the control group. Vac4all is using Rehydragel™ (Manufacturer Reheis Inc.) which is a highly active protein adsorbent specially compounded for use as a fluid adjuvant. It has low oxide content and is carefully controlled for Al2O3 content and protein binding capacity. It has a lower viscosity than competing adjuvants, which makes it easier to process and handle.
Subjects in the control group will be administered a 0.5 ml injection in a 2-dose schedule at 28 days interval. Each injection will contain approximately 600 µg of Al(OH)3 per injected dose corresponding to 200 µg equivalent of Al3+, similar to the amount being administered in the vaccine group.
| Study group | Role | What they receive |
|---|---|---|
| PEBS Low dose | Experimental | Not described Receives: Biological: Lyophilised PEBS synthetic protein (PfPEBS) |
| PEBS High dose | Experimental | Not described Receives: Biological: Lyophilised PEBS synthetic protein (PfPEBS) |
| Control | Active comparator | Not described Receives: Other: Rehydragel™ HPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events following vaccination
The safety and reactogenicity of the vaccine will be assessed by comparing the proportion and severity of expected and unexpected adverse events as well as serious adverse events (SAE) between groups.
Measured: Up to one year following first vaccination
Change from baseline of antibodies active in the ADCI assay
The vaccine antigen should induce adequate antibodies that are active in the ADCI assay, which measures parasite killing of erythrocytic stages of the malaria parasite by antibodies in Monocyte-dependant manner and is hypothesized to be able to provide protection against clinical malaria disease.
Measured: Within one year following first vaccination
Parasitemia following mosquito challenge
Subjects will be monitored for emergence of malaria parasites in the blood, using the gold standard of thick film slide microscopy, and rapid diagnostic testing, RT-PCR and LAMP. Treatment will be initiated as soon as subjects are parasitemic, defined as >1 parasites per 400 fields in a thick blood film, OR a positive RDT OR two positive RT-PCR OR one positive result with RT-PCR AND one positive result with LAMP OR two positive results with two different methods.
Measured: From Day 4 up to Day 21 post challenge
Secondary outcomes (3)
Antibodies against synthetic PEBS
This will be measured by ELISA
Measured: Within one year following first vaccination
Antibodies against parasite antigen
This will be measured by the following methods: whole parasite extract, ELISA, Western Blot, IFAT
Measured: Within one year following first vaccination
PEBS Interferon-Gamma
This will be measured by ELISPOT
Measured: Within one year following first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vac4All
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire Vaudois, Radboud University Medical Center, European Commission
- Responsible party
- Sponsor
- Investigators
- Pierre L Druilhe, MD, Study director, Vac4AllFrancois Spertini, MD, Principal investigator, Centre hospitalier universitaire vaudois (CHUV)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605786
- Sponsor's protocol ID
- Pf PEBS-Ia-IIa
- Other IDs
- 2012-002294-54
- Acronym
- PEBS-POC1
- Status last verified
- May 2012
- First submitted
- 18 May 2012
- Last updated
- 25 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I and IIa Trial for Assessment of Safety, Immunogenicity (Phase Ia) and Efficacy (Phase IIa) Against Sporozoite Challenge of P. Falciparum Pre-Erythrocytic and Blood Stage (PfPEBS-LSP) Malaria Vaccine Candidate
- ClinicalTrials.gov ID
- NCT01605786
- Acronym / sponsor ID
- PEBS-POC1 / Pf PEBS-Ia-IIa
- Conditions
- Malaria
- Keywords
- Malaria, Plasmodium falciparum, vaccine, ADCI, sporozoite challenge, pre-erythrocytic, erythrocytic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Vac4AllIndustry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire Vaudois, Radboud University Medical Center, European Commission
- Study start
- May 2012
- Primary completion
- May 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 25 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to test the hypothesis that the malaria antigen PfPEBS, manufactured as a synthetic protein and adjuvanted with aluminium hydroxide will be well-tolerated and immunogenic (Phase 1), functionally active against the erythrocytic stages (Phase 1) and efficacious (Phase 2) against the pre-erythrocytic stages in protecting against an artificial malaria challenge using Pf sporozoites in a healthy adult population.
Detailed description
The study will enroll 36 healthy adult subjects (18-45 years) and randomize them in a double-blind manner into 3 arms of 12 subjects each; 2 of the arms will receive either 5μg or 30μg, both adjuvanted with aluminium hydroxide, given as a 2-dose schedule with a 28 day interval. The third arm of 12 subjects will act as controls, and they will receive aluminium hydroxide only injections.
If the safety and immunogenicity results permit, the subjects will be challenged with live mosquito challenge delivering P falciparum sporozoites to assess pre-erythrocytic vaccine efficacy.
The PfPEBS molecule has been found to have in vivo and in vitro functional activity against the two stages that are clinically significant for malaria namely the pre-erythrocytic stages (sporozoite and liver stages) and the erythrocytic stages.
The formulation is a simple combination of a synthetic protein of 131 amino acids adjuvanted with aluminum hydroxide, the adjuvant with the widest safety records.
The combined Phase 1/2a study is designed in order to achieve 3 co-primary objectives
- Phase 1: To demonstrate safety and tolerability
- Phase 1: To measure the activity against the asexual blood stage of the parasite which is only indirectly estimated by the functional activity of elicited antibodies in ADCI under in-vitro conditions
- Phase 2: To demonstrate efficacy against liver stages by measuring the proportion of subject that are protected following a live sporozoite challenge.
The mechanisms of defenses differ for "liver stages" and "erythrocytic stages". Defenses against "liver stages" are strongly related to the secretion of interferon γ by CD4+Th1 cells, whereas for blood stages the defences depend on antibodies.
Preliminary studies have demonstrated that low antigen doses such as 5 or 2μg produce strong CD4+Th1- interferon γ secreting cells with low antibody titers, whereas higher antigen doses such as 30 or 50μg induce lower CD4 Th1 cell response and markedly higher antibody responses.
Therefore the choice of the two dose ranges for the Pf-PEBS clinical trial protocol is aimed at testing the two main efficacy objectives, one against "liver stages" with a low dose, the other against "the blood stages" with the higher dose.
The Sponsor for the two Phases is Vac4all. The funder for the Phase Ia is the EMVDA programme of the European Commission. The funder for the Phase IIa is Vac4all
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PEBS Low dose | Experimental | Biological: Lyophilised PEBS synthetic protein (PfPEBS) |
| PEBS High dose | Experimental | Biological: Lyophilised PEBS synthetic protein (PfPEBS) |
| Control | Active comparator | Other: Rehydragel™ HPA |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Male and female age > 18 and < 45 years
- Good general health based on history, physical en laboratory examination
- Available for and willingness to undergo a P. falciparum sporozoite infected mosquito challenge following the immunization course
- Resident in or near Lausanne for the duration of the study having 24h access to a mobile telephone
- Willingness to stay in special accommodation (hotel or equivalent) from day 5 up to one day after parasite positivity , or up to day 15 post EHMI
Key exclusion criteria (28 listed)
- Any history of malaria
- Known exposure to malaria in the previous 6 months, defined as a visit to a malaria endemic region. For practical purposes, all regions for which malaria chemoprophylaxis is advised by travel clinic are considered malaria endemic
- Planned to travel to endemic malaria areas during the study period
- Prior administration of an investigational malaria vaccine
- Administration of a vaccine or gammaglobulin not foreseen by the clinical trial protocol within 30 days prior to the first immunization and up to six months after the last immunization.
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 |
|---|---|---|
| Lyophilised PEBS synthetic protein (PfPEBS)PfPEBS, is a synthetic polypeptide corresponding to amino acids 3112 to 3244 (131 aa) from the Pf 11.1 antigen in 3D7 parasite sequence. It is presented as lyophilised product in multi-dose vials (containing 105 μg for 3 doses of 30 μg ), looking like amorphous white powder. The vaccine is produced by SYNPROSIS in France. The 5μg dose vaccine will be formulated extemporaneously in aluminium hydroxide adjuvant and given as a 2-dose schedule with a 28 day interval. | Biological | PEBS Low dose |
| Lyophilised PEBS synthetic protein (PfPEBS)PfPEBS-LSP, is a synthetic polypeptide corresponding to amino acids 3112 to 3244 (131aa) from the Pf 11.1 antigen in 3D7 parasite sequence. It is presented as lyophilised product in multi-dose vials (containing 105 μg for 3 doses of 30 μg ), looking like amorphous white powder. The vaccine is produced by SYNPROSIS in France. The 30 μg dose vaccine will be formulated extemporaneously in aluminium hydroxide adjuvant and given as a 2-dose schedule with a 28 day interval. | Biological | PEBS High dose |
| Rehydragel™ HPAAluminium hydroxide adjuvant is being used as the adjuvant for the vaccine and will be used as the comparator in the control group. Vac4all is using Rehydragel™ (Manufacturer Reheis Inc.) which is a highly active protein adsorbent specially compounded for use as a fluid adjuvant. It has low oxide content and is carefully controlled for Al2O3 content and protein binding capacity. It has a lower viscosity than competing adjuvants, which makes it easier to process and handle. Subjects in the control group will be administered a 0.5 ml injection in a 2-dose schedule at 28 days interval. Each injection will contain approximately 600 µg of Al(OH)3 per injected dose corresponding to 200 µg equivalent of Al3+, similar to the amount being administered in the vaccine group. | Other | Control |
Primary outcome
Adverse events following vaccination
Time frame: Up to one year following first vaccination
The safety and reactogenicity of the vaccine will be assessed by comparing the proportion and severity of expected and unexpected adverse events as well as serious adverse events (SAE) between groups.
Change from baseline of antibodies active in the ADCI assay
Time frame: Within one year following first vaccination
The vaccine antigen should induce adequate antibodies that are active in the ADCI assay, which measures parasite killing of erythrocytic stages of the malaria parasite by antibodies in Monocyte-dependant manner and is hypothesized to be able to provide protection against clinical malaria disease.
Parasitemia following mosquito challenge
Time frame: From Day 4 up to Day 21 post challenge
Subjects will be monitored for emergence of malaria parasites in the blood, using the gold standard of thick film slide microscopy, and rapid diagnostic testing, RT-PCR and LAMP. Treatment will be initiated as soon as subjects are parasitemic, defined as >1 parasites per 400 fields in a thick blood film, OR a positive RDT OR two positive RT-PCR OR one positive result with RT-PCR AND one positive result with LAMP OR two positive results with two different methods.
3 secondary outcomes
Antibodies against synthetic PEBS
Time frame: Within one year following first vaccination
Antibodies against parasite antigen
Time frame: Within one year following first vaccination
PEBS Interferon-Gamma
Time frame: Within one year following first vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2012.
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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.
Pierre L Druilhe, MD study director
Vac4All
Francois Spertini, MD principal investigator
Centre hospitalier universitaire vaudois (CHUV)
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 Lyophilised PEBS synthetic protein (PfPEBS) and Rehydragel™ HPA in people with Malaria, run by Vac4All at 1 site in Switzerland.
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 13 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 25 May 2012. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Druilhe, MD (+33142733541, druilhe@vac4all.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events following vaccination (time frame: Up to one year following first vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 May 2012.