MalariaPhase 2NCT04020653
A Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
A Phase 2 study testing 5-aminolevulinic acid hydrochloride (5-ALA HCl) 600 mg QD, Sodium ferrous citrate (SFC) 472 mg QD and Artemisinin-based combination (ACT) in people with Malaria, run by Neopharma Japan Co., Ltd..
Trial summary
This is a pilot, double-blind, randomized, parallel-group, placebo-control, exploratory study to evaluate the efficacy and safety of 5-aminolevulinic acid hydrochloride (5-ALA HCl) and sodium ferrous citrate (SFC) added on artemisinin-based combination therapy (ACT) compared with ACT alone in the treatment of malaria. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Malaria
- What is being tested?
- 5-aminolevulinic acid hydrochloride (5-ALA HCl) 600 mg QD, Sodium ferrous citrate (SFC) 472 mg QD and Artemisinin-based combination (ACT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 6 Sep 2019to 30 Sep 2020
- Phase
- Phase 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female patients of 18 to 60 years inclusive.
- Weighing 35 to 90 kg.
- Women with child bearing potential willing to give consent for pregnancy test.
- Presence of symptomatic uncomplicated malaria of all species inclusive with a diagnosis confirmed by:
- Microscopically confirmed parasite infection, between 500 and 100,000 asexual parasite count/μL of blood.
- Fever, as defined by axillary/tympanic of ≥37.5°C within 24 hours before randomization (must be documented).
- Patients must be willing and able to give written informed consent and comply with all study visits and procedures. If a patient cannot read informed consent and/or write a signature, an impartial witness who speaks the language of the patient must be present during the entire informed consent process and discussion with the patient.
Who cannot join
- Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization (WHO) Criteria 2010.
- Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment.
- Known history of photo-hypersensitivity, porphyria, or hemochromatosis.
- Have taken any medication with antimalarial or antibiotic with antimalarial effect within 14 days before randomization.
- Received an investigational drug within the past 28 days.
- Patients whose Hemoglobin (Hb) level is lower than 8 g/dL.
Show all 14Show fewer
- Liver function tests (aspartate aminotransferase/alanine aminotransferase [AST/ALT] levels) more than 2.5 times upper limit of normal values.
- Known human immunodeficiency virus (HIV) or Hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg) positive, testing is not required.
- Known significant renal impairment as indicated by serum creatinine of ≥1.4 mg/dL or estimated glomerular filtration rate (eGFR) of <45 mL/min.
- Known history of hypersensitivity, allergic or adverse reactions to 5-aminolevulinic acid and sodium ferrous citrate.
- Presence or history of uncontrolled systemic disease.
- Female patients who are pregnant or breast-feeding.
- Any other condition in the opinion of the investigator makes the patient unsuitable for study
- Received any medication specified as contraindication for ACT or affecting blood concentration of ACT within 5 times the half-life of each medication before the first dose of study medication.
About this study
Official title: A Pilot, Double-blind, Randomized, Parallel-group, Placebo-controlled, Exploratory Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
This is a pilot, double-blind, randomized, parallel-group, placebo-control, exploratory study to evaluate the efficacy and safety of 5-aminolevulinic acid hydrochloride (5-ALA HCl) and sodium ferrous citrate (SFC) added on artemisinin-based combination therapy (ACT) compared with ACT alone in the treatment of malaria. Patients who are suffering from uncomplicated malaria, are eligible for randomization.The study will be conducted in a total of 75 patients with uncomplicated malaria.
Read the detailed description
Approximately 75 patients will be randomized in a 1:2:2 ratio to 3 arms:
Arm 1: placebo+ACT group (15 patients)
Arm 2: 5 ALA/SFC+Placebo+ACT twice daily (BID) (30 patients)
Arm 3: 5-ALA/SFC+Placebo+ACT once daily (QD) (30 patients)
The study duration will be a maximum of 98 days with treatment period of 7 days and follow-up period of 91 days.
- Conditions
- Malaria
- Being tested
- 5-aminolevulinic acid hydrochloride (5-ALA HCl) 600 mg QD, Sodium ferrous citrate (SFC) 472 mg QD, Artemisinin-based combination (ACT), Placebo, 5-aminolevulinic acid hydrochloride (5-ALA HCl) 300 mg BID
- Keywords
- Uncomplicated malaria, sodium ferrous citrate (SFC), 5-aminolevulinic acid hydrochloride (5-ALA HCl), artemisinin-based combination therapy
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-aminolevulinic acid hydrochloride (5-ALA HCl) 600 mg QDDrug
5-ALA HCl 150 mg capsules will be given to the patients as 600 mg QD
Sodium ferrous citrate (SFC) 472 mg QDDrug
SFC 118 mg capsules will be given to the patients as 472 mg QD
Artemisinin-based combination (ACT)Drug
Also called Artemether 20 mg and lumefantrine 120 mg
Tablets of ACT will be administered following Dosage and Administration in the package insert of ACT. ACT will be supplied as a combination tablet.
PlaceboDrug
Matching placebo capsules to 5-ALA HCl and SFC will be administered to the patients
5-aminolevulinic acid hydrochloride (5-ALA HCl) 300 mg BIDDrug
5-ALA HCl 150 mg capsules will be given to the patients as 300 mg BID
Sodium ferrous citrate (SFC) 236 mg BIDDrug
SFC 118 mg capsules will be given to the patients as 236 mg BID
| Study group | Role | What they receive |
|---|---|---|
| Placebo + ACT | Placebo comparator | Patients will receive placebo for Day 1 to Day 7 and ACT (as per package instruction) for Day 1 to Day 3. Receives: Drug: Artemisinin-based combination (ACT); Drug: Placebo |
| 5 ALA/SFC+placebo+ACT BID | Experimental | 5-ALA HCl 300 mg and SFC 236 mg will be administered BID for Day 1 to Day 7 and ACT (as per package instruction) for Day 1 to Day 3.
Patients will receive 5-ALA HCl+Placebo and SFC+Placebo at odd number of study medication dosing (Dose 1, 3, 5, 7, 9, 11, 13) and only 5-ALA HCl and SFC at even numbers of study medication dosing (Dose 2, 4, 6, 8, 10,12, 14). Receives: Drug: Artemisinin-based combination (ACT); Drug: Placebo; Drug: 5-aminolevulinic acid hydrochloride (5-ALA HCl) 300 mg BID; Drug: Sodium ferrous citrate (SFC) 236 mg BID |
| 5-ALA/SFC+placebo+ACT QD | Experimental | 5-ALA HCl 600 mg and SFC 472 mg will be administered QD in the morning or evening for Day 1 to Day 7 and ACT (as per package instruction) for Day 1 to Day 3. Patients will receive 5-ALA HCl and SFC at odd number of study medication dosing (Dose 1, 3, 5, 7) and placebo at even numbers of study medication dosing (Dose 2, 4, 6). Receives: Drug: 5-aminolevulinic acid hydrochloride (5-ALA HCl) 600 mg QD; Drug: Sodium ferrous citrate (SFC) 472 mg QD; Drug: Artemisinin-based combination (ACT); Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events
Number of patients with any adverse events or clinically significant abnormal laboratory parameters to investigate safety and tolerability of 5-ALA HCl and SFC in simultaneous administration with ACT.
Measured: From screening visit (Day -1) untill the Follow-up Visit (Day 98)
Cure rate on Day 28
Cure rate is defined as the proportion of patients with polymerase chain reaction (PCR)-corrected Adequate Clinical and Parasitological Response (ACPR). PCR-corrected ACPR is defined as patients with clearance of asexual parasites within 28 days of initiation of study medication and without recrudescence within 28 days. Cure rate to investigate the preliminary efficacy of 5-ALA HCl and SFC in simultaneous administration with ACT.
Measured: Day 28
Parasite Clearance Time
Time from first dosing to time of first of 4 consecutive readings with zero parasite count in blood. Calculated based on parasite count in blood every 4 hours after the start of study medication for 72 hours until there are 4 consecutive negative readings.
Measured: Every 4 hours for 72 hours from Day 1 to Day 7 until 4 consecutive negative readings
Fever Reduction Time
Time to Fever Reduction is defined as the time from first dosing to first normal reading of temperature (<37.5 °C) for two consecutive normal temperature reading plus confirmed normal temperature every 4 hours after the start of study medication for 72 hours
Measured: Every 4 hours for 72 hours from Day 1 to Day 7
Gametocyte Clearance Time
Time from the first dose until first total and continued disappearance of gametocytes which remains at least a further 24 hours
Measured: Day 1 to Day 7 + 24 hours
Change in inflammatory parameter: C-reactive protein
Change from baseline in C-reactive protein to investigate change in inflammatory parameters
Measured: Days 1, 3, 7, and 28
Change in inflammatory parameter: interleukin-6
Change from baseline in interleukin-6 to investigate change in inflammatory parameters
Measured: Days 1, 3, 7, and 28
Change in inflammatory parameter: tumor necrosis factor (TNF)-alpha
Change from baseline in tumor necrosis factor (TNF)-alpha to investigate change in inflammatory parameters
Measured: Days 1, 3, 7, and 28
Change in iron metabolism: Serum iron
Change from baseline in serum iron to investigate change in iron metabolism parameters
Measured: Days 1, 3, 7, 28, and 98
Change in iron metabolism: Hepcidin
Change from baseline in hepcidin to investigate change in iron metabolism parameters
Measured: Days 1, 3, 7, 28, and 98
Change in iron metabolism: total iron binding capacity (TIBC)
Change from baseline in total iron binding capacity (TIBC) to investigate change in iron metabolism parameters
Measured: Days 1, 3, 7, 28, and 98
Change in iron metabolism: unsaturated iron binding capacity (UIBC)
Change from baseline in unsaturated iron binding capacity (UIBC) to investigate change in iron metabolism parameters
Measured: Days 1, 3, 7, 28, and 98
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start6 Sep 2019 (estimated)
- Primary completion31 May 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Why it stopped: Considering the Thai FDA requirement, changes of Malaria cases in Thailand and EC recommendation, the decision to withdrawal the study was made.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neopharma Japan Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04020653
- Sponsor's protocol ID
- NPJ005-MAL-0122
- Status last verified
- Feb 2020
- First submitted
- 12 Jul 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Double-blind, Randomized, Parallel-group, Placebo-controlled, Exploratory Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy (ACT) in Adult Patients With Uncomplicated Malaria
- ClinicalTrials.gov ID
- NCT04020653
- Acronym / sponsor ID
- NPJ005-MAL-0122
- Conditions
- Malaria
- Keywords
- Uncomplicated malaria, sodium ferrous citrate (SFC), 5-aminolevulinic acid hydrochloride (5-ALA HCl), artemisinin-based combination therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Considering the Thai FDA requirement, changes of Malaria cases in Thailand and EC recommendation, the decision to withdrawal the study was made.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Neopharma Japan Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 6 Sep 2019 (estimated)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 16 Jul 2019 (actual)
- 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 is a pilot, double-blind, randomized, parallel-group, placebo-control, exploratory study to evaluate the efficacy and safety of 5-aminolevulinic acid hydrochloride (5-ALA HCl) and sodium ferrous citrate (SFC) added on artemisinin-based combination therapy (ACT) compared with ACT alone in the treatment of malaria. Patients who are suffering from uncomplicated malaria, are eligible for randomization.The study will be conducted in a total of 75 patients with uncomplicated malaria.
Detailed description
Approximately 75 patients will be randomized in a 1:2:2 ratio to 3 arms:
Arm 1: placebo+ACT group (15 patients)
Arm 2: 5 ALA/SFC+Placebo+ACT twice daily (BID) (30 patients)
Arm 3: 5-ALA/SFC+Placebo+ACT once daily (QD) (30 patients)
The study duration will be a maximum of 98 days with treatment period of 7 days and follow-up period of 91 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo + ACT | Placebo comparator | Drug: Artemisinin-based combination (ACT), Drug: PlaceboPatients will receive placebo for Day 1 to Day 7 and ACT (as per package instruction) for Day 1 to Day 3. |
| 5 ALA/SFC+placebo+ACT BID | Experimental | Drug: Artemisinin-based combination (ACT), Drug: Placebo, Drug: 5-aminolevulinic acid hydrochloride (5-ALA HCl) 300 mg BID, Drug: Sodium ferrous citrate (SFC) 236 mg BID5-ALA HCl 300 mg and SFC 236 mg will be administered BID for Day 1 to Day 7 and ACT (as per package instruction) for Day 1 to Day 3. Patients will receive 5-ALA HCl+Placebo and SFC+Placebo at odd number of study medication dosing (Dose 1, 3, 5, 7, 9, 11, 13) and only 5-ALA HCl and SFC at even numbers of study medication dosing (Dose 2, 4, 6, 8, 10,12, 14). |
| 5-ALA/SFC+placebo+ACT QD | Experimental | Drug: 5-aminolevulinic acid hydrochloride (5-ALA HCl) 600 mg QD, Drug: Sodium ferrous citrate (SFC) 472 mg QD, Drug: Artemisinin-based combination (ACT), Drug: Placebo5-ALA HCl 600 mg and SFC 472 mg will be administered QD in the morning or evening for Day 1 to Day 7 and ACT (as per package instruction) for Day 1 to Day 3. Patients will receive 5-ALA HCl and SFC at odd number of study medication dosing (Dose 1, 3, 5, 7) and placebo at even numbers of study medication dosing (Dose 2, 4, 6). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female patients of 18 to 60 years inclusive.
- Weighing 35 to 90 kg.
- Women with child bearing potential willing to give consent for pregnancy test.
- Presence of symptomatic uncomplicated malaria of all species inclusive with a diagnosis confirmed by:
- Patients must be willing and able to give written informed consent and comply with all study visits and procedures. If a patient cannot read informed consent and/or write a signature, an impartial witness who speaks the language of the patient must be present during the entire informed consent process and discussion with the patient.
Key exclusion criteria (14 listed)
- Patients with signs and symptoms of severe/complicated malaria requiring parenteral treatment according to the World Health Organization (WHO) Criteria 2010.
- Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study or inability to tolerate oral treatment.
- Known history of photo-hypersensitivity, porphyria, or hemochromatosis.
- Have taken any medication with antimalarial or antibiotic with antimalarial effect within 14 days before randomization.
- Received an investigational drug within the past 28 days.
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 |
|---|---|---|
| 5-aminolevulinic acid hydrochloride (5-ALA HCl) 600 mg QD5-ALA HCl 150 mg capsules will be given to the patients as 600 mg QD | Drug | 5-ALA/SFC+placebo+ACT QD |
| Sodium ferrous citrate (SFC) 472 mg QDSFC 118 mg capsules will be given to the patients as 472 mg QD | Drug | 5-ALA/SFC+placebo+ACT QD |
| Artemisinin-based combination (ACT)Also: Artemether 20 mg and lumefantrine 120 mgTablets of ACT will be administered following Dosage and Administration in the package insert of ACT. ACT will be supplied as a combination tablet. | Drug | 5 ALA/SFC+placebo+ACT BID, 5-ALA/SFC+placebo+ACT QD, Placebo + ACT |
| PlaceboMatching placebo capsules to 5-ALA HCl and SFC will be administered to the patients | Drug | 5 ALA/SFC+placebo+ACT BID, 5-ALA/SFC+placebo+ACT QD, Placebo + ACT |
| 5-aminolevulinic acid hydrochloride (5-ALA HCl) 300 mg BID5-ALA HCl 150 mg capsules will be given to the patients as 300 mg BID | Drug | 5 ALA/SFC+placebo+ACT BID |
| Sodium ferrous citrate (SFC) 236 mg BIDSFC 118 mg capsules will be given to the patients as 236 mg BID | Drug | 5 ALA/SFC+placebo+ACT BID |
Primary outcome
Number of patients with adverse events
Time frame: From screening visit (Day -1) untill the Follow-up Visit (Day 98)
Number of patients with any adverse events or clinically significant abnormal laboratory parameters to investigate safety and tolerability of 5-ALA HCl and SFC in simultaneous administration with ACT.
Cure rate on Day 28
Time frame: Day 28
Cure rate is defined as the proportion of patients with polymerase chain reaction (PCR)-corrected Adequate Clinical and Parasitological Response (ACPR). PCR-corrected ACPR is defined as patients with clearance of asexual parasites within 28 days of initiation of study medication and without recrudescence within 28 days. Cure rate to investigate the preliminary efficacy of 5-ALA HCl and SFC in simultaneous administration with ACT.
Parasite Clearance Time
Time frame: Every 4 hours for 72 hours from Day 1 to Day 7 until 4 consecutive negative readings
Time from first dosing to time of first of 4 consecutive readings with zero parasite count in blood. Calculated based on parasite count in blood every 4 hours after the start of study medication for 72 hours until there are 4 consecutive negative readings.
Fever Reduction Time
Time frame: Every 4 hours for 72 hours from Day 1 to Day 7
Time to Fever Reduction is defined as the time from first dosing to first normal reading of temperature (<37.5 °C) for two consecutive normal temperature reading plus confirmed normal temperature every 4 hours after the start of study medication for 72 hours
Gametocyte Clearance Time
Time frame: Day 1 to Day 7 + 24 hours
Time from the first dose until first total and continued disappearance of gametocytes which remains at least a further 24 hours
Change in inflammatory parameter: C-reactive protein
Time frame: Days 1, 3, 7, and 28
Change from baseline in C-reactive protein to investigate change in inflammatory parameters
Change in inflammatory parameter: interleukin-6
Time frame: Days 1, 3, 7, and 28
Change from baseline in interleukin-6 to investigate change in inflammatory parameters
Change in inflammatory parameter: tumor necrosis factor (TNF)-alpha
Time frame: Days 1, 3, 7, and 28
Change from baseline in tumor necrosis factor (TNF)-alpha to investigate change in inflammatory parameters
Change in iron metabolism: Serum iron
Time frame: Days 1, 3, 7, 28, and 98
Change from baseline in serum iron to investigate change in iron metabolism parameters
Change in iron metabolism: Hepcidin
Time frame: Days 1, 3, 7, 28, and 98
Change from baseline in hepcidin to investigate change in iron metabolism parameters
Change in iron metabolism: total iron binding capacity (TIBC)
Time frame: Days 1, 3, 7, 28, and 98
Change from baseline in total iron binding capacity (TIBC) to investigate change in iron metabolism parameters
Change in iron metabolism: unsaturated iron binding capacity (UIBC)
Time frame: Days 1, 3, 7, 28, and 98
Change from baseline in unsaturated iron binding capacity (UIBC) to investigate change in iron metabolism parameters
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Evaluation, Treatment and Monitoring of Patients With a Known or Suspected Parasitic Infection
Malaria, Intestinal Worms
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-aminolevulinic acid hydrochloride (5-ALA HCl) 600 mg QD, Sodium ferrous citrate (SFC) 472 mg QD and Artemisinin-based combination (ACT) in people with Malaria, run by Neopharma Japan Co., Ltd..
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 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: withdrawn, as of the sponsor's last update on 3 Mar 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. 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of patients with adverse events (time frame: From screening visit (Day -1) untill the Follow-up Visit (Day 98)). The study lists 12 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 3 Mar 2020.