NASH - Nonalcoholic SteatohepatitisPhase 2NCT03291249
Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With NASH and T2DM
A Phase 2 study testing Foralumab and Omeprazole 20mg in people with NASH - Nonalcoholic Steatohepatitis and NAFLD, run by Tiziana Life Sciences LTD.
Trial summary
This is a randomized, placebo-controlled, four-arm, double-blind study. Subjects will be randomized (1:1:1:1) to receive either a daily oral placebo solution or a daily oral dose of 0.5 mg, 2.5 mg or 5.0 mg Foralumab Solution for 30 consecutive days. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis, NAFLD, T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- Foralumab and Omeprazole 20mg
- 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
- 1 Dec 2017to 1 Jun 2019
- 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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Provision of written informed consent
- Diagnosis of T2DM
- HbA1c < 9.0 while on standard of care
- Historical histology-based confirmation of NASH within 12 months prior to screening OR
- Diagnosis of NAFLD based on all the following:
Show all 11Show fewer
- Presentation of at least one other parameter of the metabolic syndrome from the following list of three:
- hypertension [≥130/85 mmHg or regularly taking an antihypertensive], (ii) dyslipidemia with high serum triglycerides [≥150 mg/dL or regularly taking medicines to lower high triglyceride levels] or low serum HDL [<50 mg/dL for women and <40 mg/dL for men], (iii) obesity (BMI > 30 kg/m2) or central obesity [waistline measurement ≥ 89 cm for women and ≥ 102 cm for men])
- ALT > 40 IU
- Fat fraction >10% in MRI performed during screening or up to 3 months prior to screening.
- Agree to the use of effective contraceptive measures, as defined in the protocol, if either male or female with child-bearing potential.
Who cannot join
- Subject with cirrhosis per biopsy (fibrosis staging score >= 4) or Fibroscan® >14 kPa within 12 months of screening.
- Presence of vascular liver disease
- Any history or evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites or hepatic encephalopathy
- Known history of chronic alcoholic liver disease, chronic hepatitis B or C infection, drug-induced liver injury (DILI), hemochromatosis, Wilson's disease, 1-antitrypsin deficiency, primary biliary cirrhosis or secondary sclerosing cholangitis, autoimmune hepatitis
- Known HIV antibody-positive
- History of liver transplantation
Show all 48Show fewer
- BMI <25kg/m2
- Clinically significant alcohol use
- Score of ≥ 2 on the CAGE questionnaire, OR
- Any subject with current significant alcohol consumption or a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 1 year prior to screening, as determined by medical history (medical chart review and/or interview). Significant alcohol consumption is defined as: females: >20 g/day; males: >30 g/day, with a standard drink in the US averaging 14 g alcohol.
- Type 1 diabetes
- Bariatric surgery within the last 5 years
- Weight loss or gain of ≥5 kg in the past 6 months or >10% change in bodyweight in the past 12 months
- Inadequate vascular access on physical examination
- Lactating/breastfeeding/pregnant at screening
- On an elemental diet or parenteral nutrition
- Concurrent conditions
- Inflammatory bowel disease
- Unstable angina, myocardial infarction, transient ischemic events, or stroke within 24 weeks of screening
- Ongoing infectious disease, excluding recurrent urinary tract infection treated with long-term antibiotic prophylaxis
- Any type of immune-mediated and/or malignant disease
- Any other concurrent condition which, in the opinion of the investigator, could impact adversely on the participating subject or on the interpretation of the study data
- Concurrent medications including:
- Amiodarone taken within 30 days of Day 1 (MBT contraindication)
- Beta-blockers: must be on a stable dose for at least 30 days prior to Day 1 (MBT contraindication)
- Statins: must be on a stable dose for at least 30 days prior to Day 1 (MBT contraindication)
- The following medications taken every day for more than 1 week over the last three months: S-adenosyl methionine (SAM-e), betaine, milk thistle and probiotic supplements (other than yoghurt) with the exception of vitamin E or gemfibrozil, which are allowed
- If >= 400 IU vitamin E on a regular basis or gemfibrozil, at any dose, are used, the dose must be stable for more than 3 months;
- immunomodulatory agents including In the last 4 weeks
- oral or parenteral antibiotics
- daily treatment with non-steroidal anti-inflammatory drugs (e.g., aspirin (>100 mg/day), ibuprofen, naproxen, imeloxicam, celecoxib)
- In the last 3 months
- systemic steroids
- daily treatment with non-steroidal anti-inflammatory drugs (e.g., aspirin (>100mg/day), ibuprofen, naproxen, meloxicam, celecoxib) over 4 or more weeks in the last 3 months
- variable dose of antilipidemic agents (HMG Co-A reductase inhibitors - "statins"). Subjects on stable dose of statins are eligible if missed no more than one week of dosing over the last 3 months
- In the last 12 months
- o azathioprine, 6-mercaptopurine, methotrexate, cyclosporin, anti-TNF alpha therapies (infliximab, adalimumab, etanercept) or anti-integrin therapies
- Any of the following laboratory abnormalities:
- Neutrophil count ≤1.0 x 109/L
- Platelets <100 x 109/L
- Hemoglobin <10g/dL
- Albumin <3.5g
- International Normalized Ratio (INR) >1.5
- Total bilirubin >1.5 x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
- Either creatinine clearance ≤60mL/minute, calculated by Cockroft Gault, or creatinine >1.5x upper limit of reference range
- Regular use of marijuana or marijuana-related products, or use of cocaine, or street drugs, as determined by medical history (medical chart review and/or interview).
- Subjects with symptoms of significant mental illness, inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to provide informed consent.
- Hypersensitivity to methacetin and/or its metabolites (i.e., paracetamol, acetaminophen)
About this study
Official title: A Randomized, Placebo-controlled ,Double-blind, Phase IIa Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
This is a randomized, placebo-controlled, four-arm, double-blind study. Subjects will be randomized (1:1:1:1) to receive either a daily oral placebo solution or a daily oral dose of 0.5 mg, 2.5 mg or 5.0 mg Foralumab Solution for 30 consecutive days. Subjects will record adverse events and daily administration of study medication in a subject diary. This will serve as a measure of compliance and record of safety and tolerability. Subjects will be followed up for 30 days following completion of treatment.
Study visits performed on Days 14, 30 and 60 of the study, will monitor metabolic parameters (body mass index [BMI] and waist circumference), serum lipid profiles, immunological markers (c-reactive protein [CRP] and an array of cytokines), hepatic enzymes and functions (13C-methacetin breath test [MBT]) and liver steatosis/fibrosis, which will be compared to baseline levels (Day 1).
The safety and tolerability of the treatment regimen will be determined by monitoring vital signs, laboratory values, adverse events and physical findings throughout the study. In addition, its efficacy will be established upon either reduced Day 30 serum alanine aminotransferase (ALT) levels, reduced hemoglobin A1c (HbA1c) or improved homeostasis model assessment (HOMA) or HOMA of insulin resistance (HOMA-IR) scores as compared to baseline (Day 1). In addition, to assess the efficacy of the tested Foralumab Solution regimen in improving overall subject status, a battery of exploratory metabolic, immunologic and hepatic markers will be evaluated on Days 30 and 60.
Read the detailed description
A randomized, placebo-controlled, double-blind, phase IIa study for assessment of the safety of Foralumab, an oral anti-CD3 antibody, in patients with nonalcoholic steatohepatitis (NASH) and type 2 diabetes mellitus (T2DM).
This is a randomized, placebo-controlled, four-arm, double-blind study. Subjects will be randomized (1:1:1:1) to receive either a daily oral placebo solution or a daily oral dose of 0.5 mg, 2.5 mg or 5.0 mg Foralumab Solution for 30 consecutive days. Subjects will record adverse events and daily administration of study medication in a subject diary. This will serve as a measure of compliance and record of safety and tolerability. Subjects will be followed up for 30 days following completion of treatment.
Study visits performed on Days 14, 30 and 60 of the study, will monitor metabolic parameters (body mass index [BMI] and waist circumference), serum lipid profiles, immunological markers (c-reactive protein [CRP] and an array of cytokines), hepatic enzymes and functions (13C-methacetin breath test [MBT]) and liver steatosis/fibrosis, which will be compared to baseline levels (Day 1).
The safety and tolerability of the treatment regimen will be determined by monitoring vital signs, laboratory values, adverse events and physical findings throughout the study. In addition, its efficacy will be established upon either reduced Day 30 serum alanine aminotransferase (ALT) levels, reduced hemoglobin A1c (HbA1c) or improved homeostasis model assessment (HOMA) or HOMA of insulin resistance (HOMA-IR) scores as compared to baseline (Day 1). In addition, to assess the efficacy of the tested Foralumab Solution regimen in improving overall subject status, a battery of exploratory metabolic, immunologic and hepatic markers will be evaluated on Days 30 and 60.
Primary: To assess the safety and tolerability of the tested Foralumab Solution regimen in subjects with both T2DM and NASH/NAFLD Secondary: To assess the efficacy of the tested Foralumab Solution regimen in improving serum ALT levels, HbA1c, HOMA or HOMA-IR scores in subjects with both T2DM and NASH/NAFLD.
Exploratory: To assess the efficacy of the tested Foralumab Solution regimen in improving overall subject status, as measured by a battery of metabolic, immunologic and hepatic markers.
48 adult subjects (≥18 years) with T2DM and who meet the inclusion criteria for NASH or NAFLD 2a Up to 25 Foralumab (TZLS-0401) is a fully human IgG1 monoclonal antibody directed against the CD3-epsilon (or CD3ε) antigen expressed on the surface of a type of white blood cell called T-cells, or T-lymphocytes. The Fc region of the antibody is mutated to reduce the cytokine release syndrome associated with parenteral administration of anti CD3. When administered orally, Foralumab is not absorbed and induces a signal at the level of the gut immune system to promote regulatory T cells systemically.
A once-daily oral dose of Foralumab solution (0.5, 2.5 or 5.0 mg) or placebo solution will be taken in the morning on an empty stomach for 30 consecutive days.
Group A will receive placebo solution for 30 days (n=12) Group B will receive 0.5 mg Foralumab Solution daily for 30 days (n=12) Group C will receive 2.5 mg Foralumab Solution daily for 30 days (n=12) Group D will receive 5.0 mg Foralumab Solution daily for 30 days (n=12)
A single 20 mg omeprazole pill will be concomitantly administered daily.
- Being tested
- Foralumab, placebo, Omeprazole 20mg
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ForalumabDrug
Also called Anti CD3
Anti CD3 mAb
placeboOther
Placebo oral solution
Omeprazole 20mgDrug
Omeprazole is a proton pump inhibitor used to neutralize stomach PH
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Group A will receive placebo solution for 30 consecutive days Receives: Other: placebo; Drug: Omeprazole 20mg |
| Group B | Experimental | Group B will receive 0.5 mg Foralumab Solution daily for 30 consecutive days Receives: Drug: Foralumab; Drug: Omeprazole 20mg |
| Group C | Experimental | Group B will receive 2.5 mg Foralumab Solution daily for 30 consecutive days Receives: Drug: Foralumab; Drug: Omeprazole 20mg |
| Group D | Experimental | Group B will receive 5.0 mg Foralumab Solution daily for 30 consecutive days Receives: Drug: Foralumab; Drug: Omeprazole 20mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity and duration for all adverse events
Incidence, severity, and duration for all adverse events (AEs), and abnormal laboratory and physical findings up until 30 days after last dose
Measured: 30 days after last dose
Abnormal laboratory findings
Incidence, severity, and duration for all adverse events (AEs), and abnormal laboratory and physical findings up until 30 days after last dose
Measured: 30 days after last dose
Abnormal physical findings
Incidence, severity, and duration for all adverse events (AEs), and abnormal laboratory and physical findings up until 30 days after last dose
Measured: 30 days after last dose
Secondary outcomes (3)
Change ALT levels
Day 30 versus Day 1 serum ALT levels
Measured: Day 30 versus Day 1 serum ALT levels
Change in HbA1c levels
HbA1c levels
Measured: Day 30 versus Day 1
change in HOMA/HOMA-IR scores
Day 30 versus Day 1 change in HOMA/HOMA-IR scores. Insulin and fasting plasma glucose will be measured to calculate HOMA/HOMA-IR
Measured: Day 30 versus Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Jun 2019 (estimated)
Why it stopped: Due to MOH request.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tiziana Life Sciences LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03291249
- Sponsor's protocol ID
- TZLS-0401-001
- Status last verified
- Aug 2017
- First submitted
- 21 Aug 2017
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled ,Double-blind, Phase IIa Assessment of the Safety of Foralumab, an Oral Anti-CD3 Antibody, in Patients With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
- ClinicalTrials.gov ID
- NCT03291249
- Acronym / sponsor ID
- TZLS-0401-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to MOH request.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tiziana Life Sciences LTDIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 25 Sep 2017 (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 randomized, placebo-controlled, four-arm, double-blind study. Subjects will be randomized (1:1:1:1) to receive either a daily oral placebo solution or a daily oral dose of 0.5 mg, 2.5 mg or 5.0 mg Foralumab Solution for 30 consecutive days. Subjects will record adverse events and daily administration of study medication in a subject diary. This will serve as a measure of compliance and record of safety and tolerability. Subjects will be followed up for 30 days following completion of treatment.
Study visits performed on Days 14, 30 and 60 of the study, will monitor metabolic parameters (body mass index [BMI] and waist circumference), serum lipid profiles, immunological markers (c-reactive protein [CRP] and an array of cytokines), hepatic enzymes and functions (13C-methacetin breath test [MBT]) and liver steatosis/fibrosis, which will be compared to baseline levels (Day 1).
The safety and tolerability of the treatment regimen will be determined by monitoring vital signs, laboratory values, adverse events and physical findings throughout the study. In addition, its efficacy will be established upon either reduced Day 30 serum alanine aminotransferase (ALT) levels, reduced hemoglobin A1c (HbA1c) or improved homeostasis model assessment (HOMA) or HOMA of insulin resistance (HOMA-IR) scores as compared to baseline (Day 1). In addition, to assess the efficacy of the tested Foralumab Solution regimen in improving overall subject status, a battery of exploratory metabolic, immunologic and hepatic markers will be evaluated on Days 30 and 60.
Detailed description
A randomized, placebo-controlled, double-blind, phase IIa study for assessment of the safety of Foralumab, an oral anti-CD3 antibody, in patients with nonalcoholic steatohepatitis (NASH) and type 2 diabetes mellitus (T2DM).
This is a randomized, placebo-controlled, four-arm, double-blind study. Subjects will be randomized (1:1:1:1) to receive either a daily oral placebo solution or a daily oral dose of 0.5 mg, 2.5 mg or 5.0 mg Foralumab Solution for 30 consecutive days. Subjects will record adverse events and daily administration of study medication in a subject diary. This will serve as a measure of compliance and record of safety and tolerability. Subjects will be followed up for 30 days following completion of treatment.
Study visits performed on Days 14, 30 and 60 of the study, will monitor metabolic parameters (body mass index [BMI] and waist circumference), serum lipid profiles, immunological markers (c-reactive protein [CRP] and an array of cytokines), hepatic enzymes and functions (13C-methacetin breath test [MBT]) and liver steatosis/fibrosis, which will be compared to baseline levels (Day 1).
The safety and tolerability of the treatment regimen will be determined by monitoring vital signs, laboratory values, adverse events and physical findings throughout the study. In addition, its efficacy will be established upon either reduced Day 30 serum alanine aminotransferase (ALT) levels, reduced hemoglobin A1c (HbA1c) or improved homeostasis model assessment (HOMA) or HOMA of insulin resistance (HOMA-IR) scores as compared to baseline (Day 1). In addition, to assess the efficacy of the tested Foralumab Solution regimen in improving overall subject status, a battery of exploratory metabolic, immunologic and hepatic markers will be evaluated on Days 30 and 60.
Primary: To assess the safety and tolerability of the tested Foralumab Solution regimen in subjects with both T2DM and NASH/NAFLD Secondary: To assess the efficacy of the tested Foralumab Solution regimen in improving serum ALT levels, HbA1c, HOMA or HOMA-IR scores in subjects with both T2DM and NASH/NAFLD.
Exploratory: To assess the efficacy of the tested Foralumab Solution regimen in improving overall subject status, as measured by a battery of metabolic, immunologic and hepatic markers.
48 adult subjects (≥18 years) with T2DM and who meet the inclusion criteria for NASH or NAFLD 2a Up to 25 Foralumab (TZLS-0401) is a fully human IgG1 monoclonal antibody directed against the CD3-epsilon (or CD3ε) antigen expressed on the surface of a type of white blood cell called T-cells, or T-lymphocytes. The Fc region of the antibody is mutated to reduce the cytokine release syndrome associated with parenteral administration of anti CD3. When administered orally, Foralumab is not absorbed and induces a signal at the level of the gut immune system to promote regulatory T cells systemically.
A once-daily oral dose of Foralumab solution (0.5, 2.5 or 5.0 mg) or placebo solution will be taken in the morning on an empty stomach for 30 consecutive days.
Group A will receive placebo solution for 30 days (n=12) Group B will receive 0.5 mg Foralumab Solution daily for 30 days (n=12) Group C will receive 2.5 mg Foralumab Solution daily for 30 days (n=12) Group D will receive 5.0 mg Foralumab Solution daily for 30 days (n=12)
A single 20 mg omeprazole pill will be concomitantly administered daily.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Other: placebo, Drug: Omeprazole 20mgGroup A will receive placebo solution for 30 consecutive days |
| Group B | Experimental | Drug: Foralumab, Drug: Omeprazole 20mgGroup B will receive 0.5 mg Foralumab Solution daily for 30 consecutive days |
| Group C | Experimental | Drug: Foralumab, Drug: Omeprazole 20mgGroup B will receive 2.5 mg Foralumab Solution daily for 30 consecutive days |
| Group D | Experimental | Drug: Foralumab, Drug: Omeprazole 20mgGroup B will receive 5.0 mg Foralumab Solution daily for 30 consecutive days |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years
- Provision of written informed consent
- Diagnosis of T2DM
- HbA1c < 9.0 while on standard of care
- Historical histology-based confirmation of NASH within 12 months prior to screening OR
Key exclusion criteria (48 listed)
- Subject with cirrhosis per biopsy (fibrosis staging score >= 4) or Fibroscan® >14 kPa within 12 months of screening.
- Presence of vascular liver disease
- Any history or evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites or hepatic encephalopathy
- Known history of chronic alcoholic liver disease, chronic hepatitis B or C infection, drug-induced liver injury (DILI), hemochromatosis, Wilson's disease, 1-antitrypsin deficiency, primary biliary cirrhosis or secondary sclerosing cholangitis, autoimmune hepatitis
- Known HIV antibody-positive
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 |
|---|---|---|
| ForalumabAlso: Anti CD3Anti CD3 mAb | Drug | Group B, Group C, Group D |
| placeboPlacebo oral solution | Other | Group A |
| Omeprazole 20mgOmeprazole is a proton pump inhibitor used to neutralize stomach PH | Drug | Group A, Group B, Group C, Group D |
Primary outcome
severity and duration for all adverse events
Time frame: 30 days after last dose
Incidence, severity, and duration for all adverse events (AEs), and abnormal laboratory and physical findings up until 30 days after last dose
Abnormal laboratory findings
Time frame: 30 days after last dose
Incidence, severity, and duration for all adverse events (AEs), and abnormal laboratory and physical findings up until 30 days after last dose
Abnormal physical findings
Time frame: 30 days after last dose
Incidence, severity, and duration for all adverse events (AEs), and abnormal laboratory and physical findings up until 30 days after last dose
3 secondary outcomes
Change ALT levels
Time frame: Day 30 versus Day 1 serum ALT levels
Change in HbA1c levels
Time frame: Day 30 versus Day 1
change in HOMA/HOMA-IR scores
Time frame: Day 30 versus Day 1
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 12 Sep 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Foralumab and Omeprazole 20mg in people with NASH - Nonalcoholic Steatohepatitis and NAFLD, run by Tiziana Life Sciences 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 11 inclusion and 48 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 12 Sep 2019. 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?
severity and duration for all adverse events (time frame: 30 days after last dose). 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 12 Sep 2019.