Alpha1-Antitrypsin DeficiencyPhase 1/2NCT02870309
Safety and Pharmacokinetics of Alpha-1 MP (Alpha1-proteinase Inhibitor (Human), Modified Process) in Participants With Alpha1-Antitrypsin Deficiency
A Phase 1/2 study testing Alpha-1 MP in people with Alpha1-Antitrypsin Deficiency, run by Grifols Therapeutics LLC at 2 sites in Japan.
Trial summary
This study is a multicenter, open-label trial to evaluate the safety and pharmacokinetics of weekly intravenous infusions of 60 mg/kg of Alpha-1 MP (alpha1-proteinase inhibitor (human), modified process) for 8 weeks. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Alpha1-Antitrypsin Deficiency
- What is being tested?
- Alpha-1 MP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesJapan
- Study dates
- 29 Jul 2016to 15 Mar 2017
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged ≥20 years at the time of providing informed consent.
- Participants with clinically apparent pulmonary emphysema diagnosed by Computed Tomography (CT) scan.
- AATD participants with documented serum alpha1-PI levels of <50 mg/dL (i.e., 11 µM) as measured by nephelometry. In participants with no previously documented serum alpha1-PI levels, their serum alpha1-PI levels measured by nephelometry during the screening period must be <50 mg/dL.
- Participants whose percentage of forced expired volume in 1 second/forced vital capacity forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) after inhalation of a bronchodilator is <70% during the screening period [equivalent to the criterion for the diagnosis of chronic obstructive pulmonary disease (COPD)].
- Participants who are willing to and able to provide signed written informed consent.
Who cannot join
- Participants with moderately or severely deteriorated lung function in the 4 weeks before the Week 1 (baseline) visit.
- Participants whose percentage of forced expired volume in 1 second/forced vital capacity (%FEV1 after inhalation of a bronchodilator is <30% during the screening period.
- Participants who have undergone lung transplantation or liver transplantation.
- Participants who have undergone any lung surgery (excluding lung biopsy) in the past 2 years.
- Participants with increased liver enzymes aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase (AST, ALT, and ALP) ≥2.5 times the upper limit of normal.
- Participants with severe complications including but not limited to congestive heart failure and liver cirrhosis.
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- Participants who have developed any malignant tumor (including malignant melanoma; however, other forms of skin cancer are excluded) in the past 5 years.
- Pregnant women, breastfeeding women, or women of childbearing potential who do not intend to use effective contraceptive methods (use of oral, injection, or implant hormonal contraceptives; placement of an intrauterine device (IUD) or intrauterine contraceptive system; concomitant use of spermatocidal foam, gel, film, cream, suppository and condoms or cervical caps; male sterilization; or abstinence) throughout the trial period or male participants who have a partner who is of childbearing potential and is unwilling to use effective contraceptive methods throughout the trial period.
- Participants with a past history of hepatitis A virus, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HAV, HBV, HCV, or HIV) infection, or participants currently presenting with clinical signs or symptoms suggestive of such infection.
- Participants with a smoking history in the past 6 months, or participants tested positive for urinary cotinine levels at the screening visit.
- Participants participating in another clinical trial within 4 weeks before the Week 1 (baseline) visit.
- Participants with a history of anaphylactic or severe systemic reactions to any plasma derived alpha1-PI product or other blood products.
- Participants who have continuously received any systemic steroid therapy at a prednisone-equivalent dose >5 mg/day within 4 weeks before the Week 1 (baseline) visit (Note: inhaled steroids are not regarded as systemic steroids).
- Participants who have used any systemic or aerosolized antibiotic drug for the treatment of COPD exacerbation within 4 weeks before the Week 1(baseline) visit.
- Participants with a previous or current diagnosis of selective, severe Immunoglobulin A (IgA) deficiency.
- Participants who are mentally challenged and cannot independently give consent.
- Participants who have difficulty in adhering to the protocol or its procedures in the opinion of the investigator.
- Participants who have medical conditions that may confound the results of this clinical trial or may endanger other participants during the participation in this clinical trial in the opinion of the investigator.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Hokkaido University Hospital
Sapporo, 060-8648
Juntendo University Hospital
Tokyo, 113-8431
About this study
Official title: Phase I/II Multicenter, Open-label Trial to Evaluate the Safety and Pharmacokinetics of Alpha-1 MP in Patients With Alpha1-Antitrypsin Deficiency
This study is a multicenter, open-label trial to evaluate the safety and pharmacokinetics of weekly intravenous infusions of 60 mg/kg of Alpha-1 MP (alpha1-proteinase inhibitor (human), modified process) for 8 weeks.
Read the detailed description
This study is a multicenter, open-label trial to evaluate the safety and pharmacokinetics of weekly intravenous (IV) infusions of 60 mg/kg of the investigational drug in participants with alpha1-antitrypsin deficiency (AATD). The trial will be conducted at approximately 5 medical institutions in Japan, aiming to enroll a minimum of 3 adult participants or more. The trial will consist of a screening period scheduled within 3 weeks before trial entry, an open-label treatment period for 8 weeks, and a pharmacokinetic (PK) evaluation period for 1 week. At the Week 9 visit when the PK evaluation period is completed, participant will be asked whether they would like to participate in an extension trial (GTI1401-OLE). For participants not intending to participate in the extension trial, the date of follow-up/study completion visit (30 days [4 weeks] after the last dose of the investigational drug) will be arranged. Participants will participate in this trial for approximately 14 weeks from the start of the screening period through the completion of the trial.
At the screening visit (scheduled within 3 weeks before trial entry), after providing informed consent (agreement based on adequate explanation and understanding of the treatment plan), participants will be evaluated for eligibility for participation during the screening period. Participants considered eligible will enter the 8-week treatment period to receive a total of 8 weekly IV infusions of 60 mg/kg of Alpha-1 MP. The initial IV infusion will be given at the Week 1 (baseline) visit. During the treatment period, participants will receive weekly IV infusions of Alpha-1 MP at the Weeks 1 (baseline), 2, 3, 4, 5, 6, 7, and 8 visits. After the last IV infusion of Alpha-1 MP at the Week 8 visit, participants will enter the 1-week PK evaluation period. During this PK evaluation period, participants will visit the study center to undergo blood sampling for PK evaluation at the PK1 visit (the next day of the Week 8 visit), the PK2 visit (2 days after the Week 8 visit), the PK5 visit (5 days after the Week 8 visit), and at the Week 9 visit. At 30 days after the last dose (Week 8), participants will visit the study center for follow-up/study completion (Week 12). All participants will undergo blood sampling for the measurement of alpha1-PI trough concentrations at the Weeks 1 (baseline), 7, and 8 visits (blood samples will be collected before dosing) as well as at the Week 9 visit.
Blood samples for the evaluation of PK parameters will be collected from Week 8 to Week 9. The blood sample collected before the infusion of Alpha-1 MP at the Week 8 visit and the blood sample for PK evaluation collected at the Week 9 visit (7 days after the infusion at the Week 8 visit) will be also used for the measurement of alpha1-PI trough concentrations for Weeks 8 and 9.
At the Week 9 visit, participants will be asked whether they would like to participate in the extension trial (GTI1401-OLE). Participants intending to participate in the extension trial will be able to continue the treatment with IV infusions of 60 mg/kg of Alpha-1 MP for at least another year (participants will be further asked whether they would like to continue the treatment at yearly intervals) for the purpose of evaluation of the safety of long-term Alpha-1 MP treatment. Participants not intending to enter the extension trial will visit the study center for follow-up/study completion at 30 days (4 weeks) after the last dose of Alpha-1 MP (Week 12).
- Conditions
- Alpha1-Antitrypsin Deficiency
- Being tested
- Alpha-1 MP
- Medical subject headings
- alpha 1-Antitrypsin Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha-1 MPBiological
Also called Prolastin-C
Alpha-1 MP is a stable, sterile, lyophilized preparation of human alpha1-PI, also known as α1-antitrypsin
| Study group | Role | What they receive |
|---|---|---|
| Alpha-1 MP | Experimental | Participants received 8 IV infusions of 60 mg/kg Alpha-1 MP administered weekly at an infusion rate not exceeding 0.08 mL/kg/min over approximately 15 minutes, up to Week 8. Receives: Biological: Alpha-1 MP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether considered related to the medicinal product. TEAEs were defined as any AE occurring after or on the first Alpha-1 MP infusion until the final visit of study.
Measured: Up to Week 12
Number of Participants With Adverse Drug Reaction (ADRs)
ADRs were defined as adverse events (AEs) which were in the investigator's opinion of causal relationship to the study treatment. AE was defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product.
Measured: Up to Week 12
Number of Participants With Serious Adverse Events (SAEs)
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to Week 12
Number of Discontinuations Due to Adverse Events (AEs) or Serious Adverse Events (SAEs)
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether considered related to the medicinal product. TEAEs were defined as any AE occurring after or on the first Alpha-1 MP infusion until the final visit of study. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Up to Week 12
Number of Participants With Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
COPD exacerbation was defined as an increase in respiratory symptoms (dyspnea, increased cough, and/or production of sputum) over baseline that usually requires medical intervention.
Measured: Up to Week 12
Secondary outcomes (1)
Trough Level of Total alpha1-PI for Weekly IV Infusions of 60 mg/kg Alpha-1 MP
Measured: Baseline (Week 1), Weeks 7, 8 (prior to the start of infusions of Alpha-1 MP) and Week 9 (168 hours post infusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study start29 Jul 2016
- Primary completion15 Mar 2017
- Study completion15 Mar 2017
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 Alpha1-Antitrypsin DeficiencyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grifols Therapeutics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grifols Japan K.K.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02870309
- Sponsor's protocol ID
- GTI1401
- Other IDs
- JapicCTI-163160
- Status last verified
- Oct 2021
- First submitted
- 12 Aug 2016
- Last updated
- 28 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Seyama K, Nukiwa T, Sato T, Suzuki M, Konno S, Takahashi K, Nishimura M, Steinmann K, Sorrells S, Chen J, Hayashi KI. Safety and pharmacokinetics of Alpha-1 MP (Prolastin(R)-C) in Japanese patients with alpha1-antitrypsin (AAT) deficiency. Respir Investig. 2019 Jan;57(1):89-96. doi: 10.1016/j.resinv.2018.09.006. Epub 2018 Nov 8.
PubMed 30416054
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Multicenter, Open-label Trial to Evaluate the Safety and Pharmacokinetics of Alpha-1 MP in Patients With Alpha1-Antitrypsin Deficiency
- ClinicalTrials.gov ID
- NCT02870309
- Acronym / sponsor ID
- GTI1401
- Conditions
- Alpha1-Antitrypsin Deficiency
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Grifols Therapeutics LLCIndustry (pharma, biotech, devices)
- Collaborators
- Grifols Japan K.K.
- Study start
- 29 Jul 2016 (actual)
- Primary completion
- 15 Mar 2017 (actual)
- Study completion
- 15 Mar 2017 (actual)
- First posted
- 17 Aug 2016 (estimated)
- Results
- Posted 18 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a multicenter, open-label trial to evaluate the safety and pharmacokinetics of weekly intravenous infusions of 60 mg/kg of Alpha-1 MP (alpha1-proteinase inhibitor (human), modified process) for 8 weeks.
Detailed description
This study is a multicenter, open-label trial to evaluate the safety and pharmacokinetics of weekly intravenous (IV) infusions of 60 mg/kg of the investigational drug in participants with alpha1-antitrypsin deficiency (AATD). The trial will be conducted at approximately 5 medical institutions in Japan, aiming to enroll a minimum of 3 adult participants or more. The trial will consist of a screening period scheduled within 3 weeks before trial entry, an open-label treatment period for 8 weeks, and a pharmacokinetic (PK) evaluation period for 1 week. At the Week 9 visit when the PK evaluation period is completed, participant will be asked whether they would like to participate in an extension trial (GTI1401-OLE). For participants not intending to participate in the extension trial, the date of follow-up/study completion visit (30 days [4 weeks] after the last dose of the investigational drug) will be arranged. Participants will participate in this trial for approximately 14 weeks from the start of the screening period through the completion of the trial.
At the screening visit (scheduled within 3 weeks before trial entry), after providing informed consent (agreement based on adequate explanation and understanding of the treatment plan), participants will be evaluated for eligibility for participation during the screening period. Participants considered eligible will enter the 8-week treatment period to receive a total of 8 weekly IV infusions of 60 mg/kg of Alpha-1 MP. The initial IV infusion will be given at the Week 1 (baseline) visit. During the treatment period, participants will receive weekly IV infusions of Alpha-1 MP at the Weeks 1 (baseline), 2, 3, 4, 5, 6, 7, and 8 visits. After the last IV infusion of Alpha-1 MP at the Week 8 visit, participants will enter the 1-week PK evaluation period. During this PK evaluation period, participants will visit the study center to undergo blood sampling for PK evaluation at the PK1 visit (the next day of the Week 8 visit), the PK2 visit (2 days after the Week 8 visit), the PK5 visit (5 days after the Week 8 visit), and at the Week 9 visit. At 30 days after the last dose (Week 8), participants will visit the study center for follow-up/study completion (Week 12). All participants will undergo blood sampling for the measurement of alpha1-PI trough concentrations at the Weeks 1 (baseline), 7, and 8 visits (blood samples will be collected before dosing) as well as at the Week 9 visit.
Blood samples for the evaluation of PK parameters will be collected from Week 8 to Week 9. The blood sample collected before the infusion of Alpha-1 MP at the Week 8 visit and the blood sample for PK evaluation collected at the Week 9 visit (7 days after the infusion at the Week 8 visit) will be also used for the measurement of alpha1-PI trough concentrations for Weeks 8 and 9.
At the Week 9 visit, participants will be asked whether they would like to participate in the extension trial (GTI1401-OLE). Participants intending to participate in the extension trial will be able to continue the treatment with IV infusions of 60 mg/kg of Alpha-1 MP for at least another year (participants will be further asked whether they would like to continue the treatment at yearly intervals) for the purpose of evaluation of the safety of long-term Alpha-1 MP treatment. Participants not intending to enter the extension trial will visit the study center for follow-up/study completion at 30 days (4 weeks) after the last dose of Alpha-1 MP (Week 12).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alpha-1 MP | Experimental | Biological: Alpha-1 MPParticipants received 8 IV infusions of 60 mg/kg Alpha-1 MP administered weekly at an infusion rate not exceeding 0.08 mL/kg/min over approximately 15 minutes, up to Week 8. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants aged ≥20 years at the time of providing informed consent.
- Participants with clinically apparent pulmonary emphysema diagnosed by Computed Tomography (CT) scan.
- AATD participants with documented serum alpha1-PI levels of <50 mg/dL (i.e., 11 µM) as measured by nephelometry. In participants with no previously documented serum alpha1-PI levels, their serum alpha1-PI levels measured by nephelometry during the screening period must be <50 mg/dL.
- Participants whose percentage of forced expired volume in 1 second/forced vital capacity forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) after inhalation of a bronchodilator is <70% during the screening period [equivalent to the criterion for the diagnosis of chronic obstructive pulmonary disease (COPD)].
- Participants who are willing to and able to provide signed written informed consent.
Key exclusion criteria (18 listed)
- Participants with moderately or severely deteriorated lung function in the 4 weeks before the Week 1 (baseline) visit.
- Participants whose percentage of forced expired volume in 1 second/forced vital capacity (%FEV1 after inhalation of a bronchodilator is <30% during the screening period.
- Participants who have undergone lung transplantation or liver transplantation.
- Participants who have undergone any lung surgery (excluding lung biopsy) in the past 2 years.
- Participants with increased liver enzymes aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase (AST, ALT, and ALP) ≥2.5 times the upper limit of normal.
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 |
|---|---|---|
| Alpha-1 MPAlso: Prolastin-CAlpha-1 MP is a stable, sterile, lyophilized preparation of human alpha1-PI, also known as α1-antitrypsin | Biological | Alpha-1 MP |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Week 12
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether considered related to the medicinal product. TEAEs were defined as any AE occurring after or on the first Alpha-1 MP infusion until the final visit of study.
Number of Participants With Adverse Drug Reaction (ADRs)
Time frame: Up to Week 12
ADRs were defined as adverse events (AEs) which were in the investigator's opinion of causal relationship to the study treatment. AE was defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: Up to Week 12
A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Discontinuations Due to Adverse Events (AEs) or Serious Adverse Events (SAEs)
Time frame: Up to Week 12
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether considered related to the medicinal product. TEAEs were defined as any AE occurring after or on the first Alpha-1 MP infusion until the final visit of study. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With Chronic Obstructive Pulmonary Disease (COPD) Exacerbations
Time frame: Up to Week 12
COPD exacerbation was defined as an increase in respiratory symptoms (dyspnea, increased cough, and/or production of sputum) over baseline that usually requires medical intervention.
1 secondary outcome
Trough Level of Total alpha1-PI for Weekly IV Infusions of 60 mg/kg Alpha-1 MP
Time frame: Baseline (Week 1), Weeks 7, 8 (prior to the start of infusions of Alpha-1 MP) and Week 9 (168 hours post infusion)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30416054Seyama K, Nukiwa T, Sato T, Suzuki M, Konno S, Takahashi K, Nishimura M, Steinmann K, Sorrells S, Chen J, Hayashi KI. Safety and pharmacokinetics of Alpha-1 MP (Prolastin(R)-C) in Japanese patients with alpha1-antitrypsin (AAT) deficiency. Respir Investig. 2019 Jan;57(1):89-96. doi: 10.1016/j.resinv.2018.09.006. Epub 2018 Nov 8.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites 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 Alpha-1 MP in people with Alpha1-Antitrypsin Deficiency, run by Grifols Therapeutics LLC at 2 sites in Japan.
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 5 inclusion and 18 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 28 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 18 Feb 2021). 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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to Week 12). The study lists 5 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 NCT02870309, 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 28 Oct 2021.