Human Parainfluenza Virus 2Phase 1NCT01139437
Safety of a Live Attenuated Human Parainfluenza Virus Type 2 (HPIV2) Vaccine for Adults, Children, and Infants
A Phase 1 study testing Standard Dose HPIV2 Vaccine and Low dose HPIV2 vaccine in people with Human Parainfluenza Virus 2, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Human parainfluenza virus type 2 (HPIV2) can result in severe respiratory illness in infants and young children. This study will test the safety of and immune response to an HPIV2 vaccine aimed at infants and children. Read more about this study
- Who is it for?
- Ages 6 months to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Parainfluenza Virus 2
- What is being tested?
- Standard Dose HPIV2 Vaccine and Low dose HPIV2 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Sep 2015
- Phase
- Phase 1
- 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 6 months to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 18 to 49 years old
- In good health, measured by lack of significant medical illness, physical examination findings, or significant laboratory abnormalities of urinalysis, complete blood count (CBC), ALT, or creatinine, as determined by the investigator
- Children 15 to 59 months of age
- Parent or guardian understands and signs the informed consent
- Seropositive for HPIV2, as defined by serum hemagglutinin inhibition (HAI) antibody titer in ratio greater than 1:8
- History has been reviewed and participant has undergone a physical examination indicating good health
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- Participant is expected to be available for the duration of the study
- Children and infants 6 to 59 months of age
- Parents or guardians can understand and sign the informed consent
- Seronegative for HPIV2 antibody, as defined by serum antibody titer HAI ratio less than or equal to 1:8, as determined within 28 days prior to inoculation
- History has been reviewed and subject has undergone a physical examination indicating good health
- Participant is expected to be available for the duration of the study
Who cannot join
- Pregnancy
- Breastfeeding
- Females of childbearing potential who are unwilling to practice effective birth control
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, or laboratory studies, including urinalysis
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the participant to understand and cooperate with the study protocol
- Other condition that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the study or would render the participant unable to comply with the protocol
Show all 45Show fewer
- Has had medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months
- History of a severe allergic reaction or anaphylaxis
- History of splenectomy
- Diagnosis of asthma within the past 2 years
- Positive enzyme-linked immunoassay (ELISA) and confirmatory Western blot tests for HIV-1
- Positive ELISA and confirmatory immunoblot tests for hepatitis C virus (HCV)
- Positive ELISA hepatitis B surface antigen (HBsAg) test
- Abnormal urinalysis or urine dip
- Known immunodeficiency syndrome
- Current use of nasal or systemic steroid medications
- Receipt of blood products (including immunoglobulin) within the past 3 months
- Current smoker unwilling to stop smoking for the duration of the study
- Participation in another investigational vaccine or drug study within 30 days of receiving the investigational vaccine
- Receipt of a live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks or immune globulin within the last 3 months prior to receiving the investigational vaccine
- Previous immunization with an HPIV2 vaccine
- Known hypersensitivity to any vaccine component
- Professional or personal responsibilities involve caring for children less than 59 months of age or for immunosuppressed individuals
- Systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg
- Body mass Index (BMI) greater than 35
- Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy, including systemic corticosteroids or bone marrow/solid organ transplant recipients (topical steroids, topical antibiotics, and topical antifungal medications are acceptable)
- Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
- Previous immunization with an HPIV2 vaccine
- Current use of nasal or systemic steroid medications
- Previous serious vaccine-associated adverse event or anaphylactic reaction
- Known hypersensitivity to any vaccine component
- Lung or heart disease, including reactive airway disease. Participants with clinically insignificant cardiac abnormalities requiring no treatment may be enrolled. Participants who wheezed once or received bronchodilator therapy once in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may also be enrolled.
- Member of a household that includes an immunocompromised individual or infants less than 6 months of age
- Attends day care with infants less than 6 months of age or immunosuppressed individuals, and parent or guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable
- Participation in another investigational vaccine or drug trial within 30 days of receiving the investigational vaccine, or while this study is ongoing
- Known or suspected impairment of immunological functions, including maternal history of positive HIV test, receiving immunosuppressive therapy, including systemic corticosteroids or bone marrow/solid organ transplant recipients (topical steroids, topical antibiotics, and topical antifungal medications are acceptable)
- Major congenital malformations, including congenital cleft palate, cytogenetic abnormalities, or serious chronic disorders
- Previous immunization with an HPIV2 vaccine
- Current use of nasal or systemic steroid medications
- Previous serious vaccine-associated adverse event or anaphylactic reaction
- Known hypersensitivity to any vaccine component
- Lung or heart disease, including reactive airway disease. Participants with clinically insignificant cardiac abnormalities requiring no treatment and those who wheezed once or received bronchodilator therapy once in the first year of life but who have not had any additional wheezing episodes or bronchodilator therapy for at least 12 months may be enrolled.
- Member of a household that includes an immunocompromised individual or infant less than 6 months of age
- Attends day care with infants less than 6 months of age or immunosuppressed individuals, and parent or guardian is unable or unwilling to suspend daycare for 14 days following immunization. Children who attend facilities that separate children by age and minimize opportunities for transmission of virus through direct physical or aerosol contact are acceptable.
- Participation in another investigational vaccine or drug trial within 28 days of receiving the investigational vaccine, or while this study is ongoing
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University, Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: A Phase I Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Human Parainfluenza Type 2 Virus Vaccine, rHPIV2 15C/948L/Δ1724 Lot PIV2#109C, Delivered as Nose Drops to Adults 18 to 49 Years of Age, HPIV2-Seropositive Children 15 to 59 Months of Age, and HPIV2-Seronegative Infants and Children 6 to 59 Months of Age
Human parainfluenza virus type 2 (HPIV2) can result in severe respiratory illness in infants and young children. This study will test the safety of and immune response to an HPIV2 vaccine aimed at infants and children.
Read the detailed description
HPIV2 is a virus that can cause severe respiratory illnesses, such as pneumonia and bronchiolitis, in infants and young children. Approximately 3% of all hospitalizations for respiratory tract diseases among infants and children are the result of HPIV2. Efforts to develop a vaccine for HPIV2 have focused on a live attenuated intranasally administered vaccine, a type of vaccine that uses a live virus that has been modified to make it weaker and easier for the immune system to get rid of. This approach is useful for several reasons: it activates two of the body's natural defenses, the antibody-mediated and the cell-mediated responses; it is immunogenic in infants who still have maternal antibodies; and it induces a mucosal immune response. This study will test the safety and immunogenicity of an HPIV2 vaccine in adults, children, and then infants.
This study will have four groups and will proceed in a step-wise fashion. The first group will consist only of adults receiving the HPIV2 vaccine. If it is deemed safe after that, children from ages 15 to 59 months who already have HPIV2 antibodies will be randomly assigned to receive either the vaccine or a placebo. The third group includes infants and children from 6 to 59 months old who do not have HPIV2 antibodies and will be randomly assigned either a lower dose of the vaccine or a placebo. The fourth group also includes infants and children from 6 to 59 months old who do not have HPIV2 antibodies and will be randomly assigned a standard dose vaccine or placebo. The vaccine will be administered as a nose drop in a single dose for all groups.
Assessments for the first two groups will take place over the 11 days following administration of the vaccine and at a 28-day follow-up. The third and fourth groups will include 22 days of assessments after vaccination, one assessment between Days 23 and 26, and assessments on Days 27, 28, 29, and 56. Measures will include a clinical assessment, a nasal wash, a phone report, and taking a temperature. Measurement of serum HPIV2 antibodies will take place at baseline and after 28 (for groups one and two) or 56 (for groups three and four) days.
- Conditions
- Human Parainfluenza Virus 2
- Being tested
- Standard Dose HPIV2 Vaccine, Low dose HPIV2 vaccine, Placebo
- Keywords
- Vaccine, HPIV2, Infants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Dose HPIV2 VaccineBiological
10^6 tissue culture infectious dose 50% (TCID50) administered intranasally in a single dose
Low dose HPIV2 vaccineBiological
10^5 TCID50 administered in a single dose
PlaceboOther
Matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Adults | Experimental | Adults ages 18 to 49 years of age. Open label. Receives: Biological: Standard Dose HPIV2 Vaccine |
| Seropositive children - vaccine | Experimental | Children ages 15 to 59 months of age who already have HPIV2 antibodies receiving the HPIV2 vaccine. Receives: Biological: Standard Dose HPIV2 Vaccine |
| Seronegative infants and children - low dose vaccine | Experimental | Infants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a low dose of the HPIV2 vaccine. Receives: Biological: Low dose HPIV2 vaccine |
| Seronegative infants and children - standard dose vaccine | Experimental | Infants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a standard dose of the HPIV2 vaccine. Receives: Biological: Standard Dose HPIV2 Vaccine |
| Seropositive children - placebo | Placebo comparator | Children ages 15 to 59 months of age who already have HPIV2 antibodies receiving a placebo. Receives: Other: Placebo |
| Seronegative infants and children - low dose placebo | Placebo comparator | Infants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a low dose of placebo. Receives: Other: Placebo |
| Seronegative infants and children - standard dose placebo | Placebo comparator | Infants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a standard dose of placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, as determined by frequency of adverse events
Measured: Measured at baseline, for 11 days after vaccination, and at 1 month follow-up
Immunogenicity, as determined by ability to cause an immunological reaction and amount of antibody induced by the vaccine
Measured: Measured at baseline and at 1 month
Infectivity, as determined by amount of vaccine shed by each recipient
Measured: Measured at baseline, for 11 days after vaccination, and at 1 month follow-up
Secondary outcomes (2)
Phenotypic stability of the vaccine virus shed
Measured: Measured at baseline and at 1 month
Number of vaccinated infants and children infected with HPIV2
Measured: Measured at baseline, for 11 days after vaccination, and at 1 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Human Parainfluenza Virus 2Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Ruth A. Karron, MD, Principal investigator, Johns Hopkins University, Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01139437
- Sponsor's protocol ID
- CIR 258
- Status last verified
- Mar 2017
- First submitted
- 7 Jun 2010
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Murphy BR, Prince GA, Collins PL, Van Wyke Coelingh K, Olmsted RA, Spriggs MK, Parrott RH, Kim HW, Brandt CD, Chanock RM. Current approaches to the development of vaccines effective against parainfluenza and respiratory syncytial viruses. Virus Res. 1988 Aug;11(1):1-15. doi: 10.1016/0168-1702(88)90063-9.
PubMed 2845680Nolan SM, Skiadopoulos MH, Bradley K, Kim OS, Bier S, Amaro-Carambot E, Surman SR, Davis S, St Claire M, Elkins R, Collins PL, Murphy BR, Schaap-Nutt A. Recombinant human parainfluenza virus type 2 vaccine candidates containing a 3' genomic promoter mutation and L polymerase mutations are attenuated and protective in non-human primates. Vaccine. 2007 Aug 21;25(34):6409-22. doi: 10.1016/j.vaccine.2007.06.028. Epub 2007 Jul 3.
PubMed 17658669
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of the Safety and Immunogenicity of the Recombinant Live-Attenuated Human Parainfluenza Type 2 Virus Vaccine, rHPIV2 15C/948L/Δ1724 Lot PIV2#109C, Delivered as Nose Drops to Adults 18 to 49 Years of Age, HPIV2-Seropositive Children 15 to 59 Months of Age, and HPIV2-Seronegative Infants and Children 6 to 59 Months of Age
- ClinicalTrials.gov ID
- NCT01139437
- Acronym / sponsor ID
- CIR 258
- Conditions
- Human Parainfluenza Virus 2
- Keywords
- Vaccine, HPIV2, Infants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jun 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Jun 2010 (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.
Human parainfluenza virus type 2 (HPIV2) can result in severe respiratory illness in infants and young children. This study will test the safety of and immune response to an HPIV2 vaccine aimed at infants and children.
Detailed description
HPIV2 is a virus that can cause severe respiratory illnesses, such as pneumonia and bronchiolitis, in infants and young children. Approximately 3% of all hospitalizations for respiratory tract diseases among infants and children are the result of HPIV2. Efforts to develop a vaccine for HPIV2 have focused on a live attenuated intranasally administered vaccine, a type of vaccine that uses a live virus that has been modified to make it weaker and easier for the immune system to get rid of. This approach is useful for several reasons: it activates two of the body's natural defenses, the antibody-mediated and the cell-mediated responses; it is immunogenic in infants who still have maternal antibodies; and it induces a mucosal immune response. This study will test the safety and immunogenicity of an HPIV2 vaccine in adults, children, and then infants.
This study will have four groups and will proceed in a step-wise fashion. The first group will consist only of adults receiving the HPIV2 vaccine. If it is deemed safe after that, children from ages 15 to 59 months who already have HPIV2 antibodies will be randomly assigned to receive either the vaccine or a placebo. The third group includes infants and children from 6 to 59 months old who do not have HPIV2 antibodies and will be randomly assigned either a lower dose of the vaccine or a placebo. The fourth group also includes infants and children from 6 to 59 months old who do not have HPIV2 antibodies and will be randomly assigned a standard dose vaccine or placebo. The vaccine will be administered as a nose drop in a single dose for all groups.
Assessments for the first two groups will take place over the 11 days following administration of the vaccine and at a 28-day follow-up. The third and fourth groups will include 22 days of assessments after vaccination, one assessment between Days 23 and 26, and assessments on Days 27, 28, 29, and 56. Measures will include a clinical assessment, a nasal wash, a phone report, and taking a temperature. Measurement of serum HPIV2 antibodies will take place at baseline and after 28 (for groups one and two) or 56 (for groups three and four) days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Adults | Experimental | Biological: Standard Dose HPIV2 VaccineAdults ages 18 to 49 years of age. Open label. |
| Seropositive children - vaccine | Experimental | Biological: Standard Dose HPIV2 VaccineChildren ages 15 to 59 months of age who already have HPIV2 antibodies receiving the HPIV2 vaccine. |
| Seronegative infants and children - low dose vaccine | Experimental | Biological: Low dose HPIV2 vaccineInfants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a low dose of the HPIV2 vaccine. |
| Seronegative infants and children - standard dose vaccine | Experimental | Biological: Standard Dose HPIV2 VaccineInfants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a standard dose of the HPIV2 vaccine. |
| Seropositive children - placebo | Placebo comparator | Other: PlaceboChildren ages 15 to 59 months of age who already have HPIV2 antibodies receiving a placebo. |
| Seronegative infants and children - low dose placebo | Placebo comparator | Other: PlaceboInfants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a low dose of placebo. |
| Seronegative infants and children - standard dose placebo | Placebo comparator | Other: PlaceboInfants and children ages 6 to 59 months of age who do not have HPIV2 antibodies receiving a standard dose of placebo. |
Who may qualify
- Ages
- 6 months to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- 18 to 49 years old
- In good health, measured by lack of significant medical illness, physical examination findings, or significant laboratory abnormalities of urinalysis, complete blood count (CBC), ALT, or creatinine, as determined by the investigator
- Children 15 to 59 months of age
- Parent or guardian understands and signs the informed consent
- Seropositive for HPIV2, as defined by serum hemagglutinin inhibition (HAI) antibody titer in ratio greater than 1:8
Key exclusion criteria (45 listed)
- Pregnancy
- Breastfeeding
- Females of childbearing potential who are unwilling to practice effective birth control
- Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, or laboratory studies, including urinalysis
- Behavioral, cognitive, or psychiatric disease that, in the opinion of the investigator, affects the ability of the participant to understand and cooperate with the study protocol
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 |
|---|---|---|
| Standard Dose HPIV2 Vaccine10^6 tissue culture infectious dose 50% (TCID50) administered intranasally in a single dose | Biological | Adults, Seronegative infants and children - standard dose vaccine, Seropositive children - vaccine |
| Low dose HPIV2 vaccine10^5 TCID50 administered in a single dose | Biological | Seronegative infants and children - low dose vaccine |
| PlaceboMatched placebo | Other | Seronegative infants and children - low dose placebo, Seronegative infants and children - standard dose placebo, Seropositive children - placebo |
Primary outcome
Safety, as determined by frequency of adverse events
Time frame: Measured at baseline, for 11 days after vaccination, and at 1 month follow-up
Immunogenicity, as determined by ability to cause an immunological reaction and amount of antibody induced by the vaccine
Time frame: Measured at baseline and at 1 month
Infectivity, as determined by amount of vaccine shed by each recipient
Time frame: Measured at baseline, for 11 days after vaccination, and at 1 month follow-up
2 secondary outcomes
Phenotypic stability of the vaccine virus shed
Time frame: Measured at baseline and at 1 month
Number of vaccinated infants and children infected with HPIV2
Time frame: Measured at baseline, for 11 days after vaccination, and at 1 month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Background: PubMed 2845680Murphy BR, Prince GA, Collins PL, Van Wyke Coelingh K, Olmsted RA, Spriggs MK, Parrott RH, Kim HW, Brandt CD, Chanock RM. Current approaches to the development of vaccines effective against parainfluenza and respiratory syncytial viruses. Virus Res. 1988 Aug;11(1):1-15. doi: 10.1016/0168-1702(88)90063-9.
- Background: PubMed 17658669Nolan SM, Skiadopoulos MH, Bradley K, Kim OS, Bier S, Amaro-Carambot E, Surman SR, Davis S, St Claire M, Elkins R, Collins PL, Murphy BR, Schaap-Nutt A. Recombinant human parainfluenza virus type 2 vaccine candidates containing a 3' genomic promoter mutation and L polymerase mutations are attenuated and protective in non-human primates. Vaccine. 2007 Aug 21;25(34):6409-22. doi: 10.1016/j.vaccine.2007.06.028. Epub 2007 Jul 3.
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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.
Ruth A. Karron, MD principal investigator
Johns Hopkins University, Bloomberg School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Standard Dose HPIV2 Vaccine and Low dose HPIV2 vaccine in people with Human Parainfluenza Virus 2, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 12 inclusion and 45 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 4 Apr 2017. 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. Some participants in this study may receive a placebo. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety, as determined by frequency of adverse events (time frame: Measured at baseline, for 11 days after vaccination, and at 1 month follow-up). 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?
On the ClinicalTrials.gov record for NCT01139437, which also lists 2 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 4 Apr 2017.