Unresectable Hepatocellular Carcinoma (HCC)Phase 1NCT02953743
Pharmacokinetic Study of E7080/Lenvatinib in Chinese Patients With Unresectable Hepatocellular Carcinoma (HCC)
A Phase 1 study testing Lenvatinib in people with Unresectable Hepatocellular Carcinoma (HCC), run by Eisai Co., Ltd. at 3 sites in China.
Trial summary
The primary purpose of this study is to assess the single- and multiple-dose pharmacokinetic (PK) profile of lenvatinib in Chinese participants with unresectable Hepatocellular Carcinoma (HCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma (HCC)
- What is being tested?
- Lenvatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2016to 28 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have confirmed diagnosis of unresectable Hepatocellular Carcinoma (HCC) with any of the following criteria:
- Histologically or cytologically confirmed diagnosis of HCC
- Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria, including cirrhosis of any etiology or with chronic hepatitis B or C infection criteria
- Participants categorized to stage B (not applicable for transarterial chemoembolization [TACE]) or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
- Adequate bone marrow function, defined as:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10^9/Liter (L)
Show all 25Show fewer
- Hemoglobin (Hb) ≥ 8.5 gram per deciliter (g/dL)
- Platelet count ≥ 75 × 10^9/L
- Adequate liver function, defined as:
- Albumin ≥ 2.8 g/dL
- Bilirubin ≤ 3.0 milligram per deciliter (mg/dL)
- Aspartate aminotransferase (AST), alkaline phosphatase (ALP), and alanine aminotransferase (ALT) ≤ 5 × the upper limit of normal (ULN)
- Adequate blood coagulation function, defined as international normalized ratio (INR) ≤ 2.3
- Adequate renal function defined as creatinine clearance > 40 milliliter per min (mL/min) calculated per the Cockcroft-Gault formula
- Adequately controlled blood pressure (BP) with up to 3 antihypertensive agents, defined as systolic BP ≤ 150 millimeter of mercury (mm Hg) and diastolic BP ≤ 90 mm Hg at screening and no change in antihypertensive therapy within 1 week prior to the registration.
- Child-Pugh A (score 5-6)
- Eastern Cooperative Oncology Group (ECOG)- performance status (PS) 0 or 1
- Survival expectation of 12 weeks or longer after starting study drug
- Males or females aged at least 18 years at the time of informed consent.
- Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta-human chorionic gonadotropin [Beta-hCG] test with a minimum sensitivity of 25 International Unit/Liter [IU/L] or equivalent units of beta-hCG). A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
- All females will be considered to be of childbearing potential unless they are postmenopausal (amenorrheic for at least 12 consecutive months, in the appropriate age group and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy or bilateral oophorectomy, all with surgery at least one month before dosing).
- Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 30 days after study drug discontinuation. If currently abstinent, the participant must agree to use a double barrier method as described above if she becomes sexually active during the study period or for 30 days after study drug discontinuation. Females who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.
- Male participants must have had a successful vasectomy (confirmed azoospermia) or they and their female partners must meet the criteria above (ie, not of childbearing potential or practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation). No sperm donation is allowed during the study period and for 30 days after study drug discontinuation.
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol as judged by the Investigator.
Who cannot join
- Imaging findings for HCC corresponding to any of the following:
- HCC with ≥50% liver occupation
- Clear invasion into the bile duct
- Portal vein invasion at the main portal branch (Vp4)
- Participants who have received lenvatinib
- Participants who have received any anti-cancer therapy (including surgery, percutaneous ethanol injection, radio frequency ablation, transarterial [chemo] embolization, hepatic intra-arterial chemotherapy, biological, immunotherapy, hormonal, any investigational drugs or radiotherapy) or any blood enhancing treatment (including blood transfusion, blood products, or agents that stimulate blood cell production, eg, granulocyte colony-stimulating factor [G-CSF]) within 28 days prior to registration.
Show all 25Show fewer
- Participants who have not recovered from toxicities as a result of prior anticancer therapy except alopecia and infertility. Recovery is defined as < Grade 2 severity per Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
- Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at screening
- Prolongation of Q wave and T wave interval corrected by the Fridericia formula (QTcF) interval to > 480 milli second (msec)
- Gastrointestinal malabsorption, or any other condition in the opinion of the investigator that might affect the absorption of lenvatinib
- Bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic INR monitoring, eg, warfarin or similar agents. Treatment with low molecular weight heparin and factor X inhibitors which do not require INR monitoring is permitted. Antiplatelet agents are prohibited throughout the study.
- Gastrointestinal bleeding event within 28 days prior to registration
- Gastric or esophageal varices that require interventional treatment within 28 days prior to randomization. Prophylaxis with pharmacologic therapy (eg, nonselective beta-blocker) is permitted.
- Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 28 days prior to registration
- Active malignancy (except for HCC or definitively treated melanoma in-situ, basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 36 months from registration.
- Any history of or current brain or subdural metastases
- Participants having > 1+ proteinuria on urine dipstick testing will undergo 24h urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥ 1 gram (g)/24 hour (h) will be ineligible.
- Surgical arterial-portal venous shunt or arterial-venous shunt.
- Any medical or other condition that in the opinion of the investigator would preclude participation in a clinical study
- Human immunodeficiency virus (HIV) positive, or active infection requiring treatment (except for hepatitis virus)
- History of drug or alcohol dependency or abuse within approximately 2 years prior to registration.
- Any participant who cannot be evaluated by dynamic CT because of allergic reaction to contrast agent of CT.
- Major surgery within 3 weeks prior to registration or scheduled for surgery during the study
- Participant who has had a liver transplant.
- Participants whose only tumor lesion(s) is in bone will be excluded
Trial locations and contacts
3 sites in 1 country.
China3 sites
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Shanghai Cancer Hospital, Fudan University
Shanghai, Shanghai Municipality
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality
About this study
The primary purpose of this study is to assess the single- and multiple-dose pharmacokinetic (PK) profile of lenvatinib in Chinese participants with unresectable Hepatocellular Carcinoma (HCC).
- Being tested
- Lenvatinib
- Keywords
- E7080, Lenvatinib, Pharmacokinetic study, Chinese participants, Unresectable Hepatocellular Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenvatinibDrug
Lenvatinib 4 mg capsules will be administered orally, once daily continuously 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.
| Study group | Role | What they receive |
|---|---|---|
| Lenvatinib 12 mg | Experimental | Participants weighing ≥ 60 kg will be enrolled in this arm. Receives: Drug: Lenvatinib |
| Lenvatinib 8 mg | Experimental | Participants weighing < 60 kg will be enrolled in this arm. Receives: Drug: Lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean maximum observed concentration (Cmax)
Measured: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean time at which the highest drug concentration occurs (tmax)
Measured: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC(0-t))
Measured: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean maximum observed concentration at steady-state (Css,max )
Measured: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean minimum observed concentration at steady-state (Css,min)
Measured: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Average steady-state concentration (Css,av)
Measured: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean time at which the highest drug concentration occurs at steady-state (tss,max)
Measured: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean area under the concentration-time curve over the dosing interval on multiple dosing (AUC(0-τ))
Measured: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Secondary outcomes (1)
Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Measured: Up to 30 days after the administration of the last dose of study drug or up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study start1 Sep 2016
- Primary completion28 Jun 2017
- Study completion28 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unresectable Hepatocellular Carcinoma (HCC)Studies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953743
- Sponsor's protocol ID
- E7080-C086-107
- Status last verified
- Feb 2021
- First submitted
- 1 Nov 2016
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Bai Y, Hu X, Ren Z, Hisai T, Yusa W, Weng L, Shiba S, Takase T. A phase I pharmacokinetic study of lenvatinib in Chinese patients with unresectable hepatocellular carcinoma. Future Oncol. 2022 Jul;18(22):2413-2424. doi: 10.2217/fon-2022-0229. Epub 2022 Jun 8.
PubMed 35674480
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of E7080/Lenvatinib in Chinese Patients With Unresectable Hepatocellular Carcinoma (HCC)
- ClinicalTrials.gov ID
- NCT02953743
- Acronym / sponsor ID
- E7080-C086-107
- Keywords
- E7080, Lenvatinib, Pharmacokinetic study, Chinese participants, Unresectable Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 28 Jun 2017 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 3 Nov 2016 (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.
The primary purpose of this study is to assess the single- and multiple-dose pharmacokinetic (PK) profile of lenvatinib in Chinese participants with unresectable Hepatocellular Carcinoma (HCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenvatinib 12 mg | Experimental | Drug: LenvatinibParticipants weighing ≥ 60 kg will be enrolled in this arm. |
| Lenvatinib 8 mg | Experimental | Drug: LenvatinibParticipants weighing < 60 kg will be enrolled in this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Participants must have confirmed diagnosis of unresectable Hepatocellular Carcinoma (HCC) with any of the following criteria:
- Participants categorized to stage B (not applicable for transarterial chemoembolization [TACE]) or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
- Adequate bone marrow function, defined as:
- Adequate liver function, defined as:
- Adequate blood coagulation function, defined as international normalized ratio (INR) ≤ 2.3
Key exclusion criteria (25 listed)
- Imaging findings for HCC corresponding to any of the following:
- Participants who have received lenvatinib
- Participants who have received any anti-cancer therapy (including surgery, percutaneous ethanol injection, radio frequency ablation, transarterial [chemo] embolization, hepatic intra-arterial chemotherapy, biological, immunotherapy, hormonal, any investigational drugs or radiotherapy) or any blood enhancing treatment (including blood transfusion, blood products, or agents that stimulate blood cell production, eg, granulocyte colony-stimulating factor [G-CSF]) within 28 days prior to registration.
- Participants who have not recovered from toxicities as a result of prior anticancer therapy except alopecia and infertility. Recovery is defined as < Grade 2 severity per Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
- Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of the first dose of study drug, or cardiac arrhythmia requiring medical treatment at screening
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 |
|---|---|---|
| LenvatinibLenvatinib 4 mg capsules will be administered orally, once daily continuously 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent. | Drug | Lenvatinib 12 mg, Lenvatinib 8 mg |
Primary outcome
Mean maximum observed concentration (Cmax)
Time frame: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean time at which the highest drug concentration occurs (tmax)
Time frame: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC(0-t))
Time frame: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean maximum observed concentration at steady-state (Css,max )
Time frame: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean minimum observed concentration at steady-state (Css,min)
Time frame: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Average steady-state concentration (Css,av)
Time frame: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean time at which the highest drug concentration occurs at steady-state (tss,max)
Time frame: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
Mean area under the concentration-time curve over the dosing interval on multiple dosing (AUC(0-τ))
Time frame: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose
1 secondary outcome
Number of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time frame: Up to 30 days after the administration of the last dose of study drug or up to approximately 1 year
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 1 Apr 2021.
- Derived from this study: PubMed 35674480Bai Y, Hu X, Ren Z, Hisai T, Yusa W, Weng L, Shiba S, Takase T. A phase I pharmacokinetic study of lenvatinib in Chinese patients with unresectable hepatocellular carcinoma. Future Oncol. 2022 Jul;18(22):2413-2424. doi: 10.2217/fon-2022-0229. Epub 2022 Jun 8.
Related trials for Unresectable Hepatocellular Carcinoma (HCC)
Not yet recruitingPhase 2
PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC
Hepatocellular Carcinoma
Active, not recruitingPhase 3
Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer
Recurrent Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v7
Active, not recruitingPhase 1/2
Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer
Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8
Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
Active, not recruiting
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma Non-resectable
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lenvatinib in people with Unresectable Hepatocellular Carcinoma (HCC), run by Eisai Co., Ltd. at 3 sites in China.
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 25 inclusion and 25 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 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China. 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 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?
Mean maximum observed concentration (Cmax) (time frame: Day 1 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 2 at pre-dose; Day 8 at pre-dose; Day 15 at pre-dose, 0.5, 1, 2, 4, 6, and 8 hours; Day 16 at pre-dose; and Day 22 at pre-dose). The study lists 8 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 NCT02953743, 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 1 Apr 2021.