UlcerPhase 2NCT02973893
Study of VF001-DP in Patients With Chronic Venous Leg Ulcers
A Phase 2 study testing VF001-DP LD and VF001-DP HD in people with Ulcer and Leg Ulcer, run by Factor Therapeutics Ltd. at 17 sites in United States.
Trial summary
The purpose of this study is to determine if VF001-DP improves wound healing in chronic venous leg ulcers compared to standard care only. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcer, Leg Ulcer, Varicose Ulcer
- What is being tested?
- VF001-DP LD and VF001-DP HD
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 17 sitesUnited States
- Study dates
- Nov 2016to Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- Ankle-Brachial Pressure Index (ABI) ≥0.80. (Calculations will be made using measurements from both posterior tibial and dorsalis pedis arteries as well as both arms).
- Presence of VLUs extending through the full thickness of the skin but not down to muscle, tendon or bone. In the case of more than one ulcer, the largest ulcer (compliant with study criteria) will be chosen as the study ulcer and treated in the study. Other ulcerations, if present on the same leg must be at least 2 cm apart from the study ulcer.
- Venous disease confirmed by Doppler ultrasonography to demonstrate reflux of >0.5 seconds in saphenous (great or small), calf perforators or the deep venous system. Patients with prior venous surgery (i.e., varicose vein stripping, endovenous ablation) may be included if they still demonstrate significant reflux in a remaining venous segment and the ulcer continues to suffer poor healing because of venous hypertension.
- Ulcer which has been present and treated with standard care (moisture retentive ulcer dressings and compression bandaging not limited to Mepitel® and Coban2®) for at least one month prior to the initial Screening Visit.
- Moderate severity ulcer at the T1 visit (post-debridement) complying with the following requirements of the Margolis Predictive Score Baseline Wound Area and Wound Duration:
Show all 12Show fewer
- 1(a) 2.5 cm2 to not-more-than 5 cm2 and not-less-than 6 months or;
- 1(b) Not-less-than 5 cm2 to not-more-than 15 cm2 and not-more-than 6 months
- Ulcer with a clean, granulating base free of adherent slough at the T1 visit (post-debridement).
- Female patients of childbearing potential, willing to use acceptable methods of contraception (birth control pills, barriers, or sexual abstinence). A urine pregnancy test must be performed, and negative at the T1 visit.
- Patient able to understand the study procedures and willing to participate in the clinical study and able to comply with study visit schedule.
- Provide signed informed consent.
Who cannot join
- Ulcer(s) deemed by the Investigator to be caused by a medical condition other than venous insufficiency. These may include, but are not limited to: fungal ulcerations, malignant ulcerations, diabetic (neuropathic) ulcerations, and ulcerations due to arterial insufficiency.
- Increase or decrease by >30% in the study ulcer surface area at the T1 visit post-debridement as compared to the S1 visit study ulcer surface area post-debridement.
- Ulcer exhibits clinical signs and symptoms of infection at S1to T1 in which case infection should be treated and the patient may after treatment be re-assessed for eligibility to enter into the study.
- Known allergy to any of the protocol-stipulated treatment procedures, or non-tolerance of multi-layer compression therapy.
- Ulcer which has undergone continuing high level of compression therapy for ≥12 months
- Ulcer, which in the opinion of the Investigator is suspicious for cancer.
Show all 26Show fewer
- A history of more than 2 weeks' treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to initial screening, or treatments with such medications during the screening period, or anticipated requirement of such medications during the course of the study.
- IGF-1 treatment or treatment with a product containing IGF-1.
- Treatment with Pentoxifylline (Trental®) within 30-days of S1 visit.
- Treatment with any investigational drug(s) or therapeutic device(s) within 30 days preceding screening (i.e., S1); or anticipated (patient or physician anticipates) use of any of these therapies during the course of the study.
- Malignant disease not in remission for 5 years or more, other than basal cell carcinoma, squamous cell carcinoma of the skin or cervical carcinoma in situ, that have been successfully treated without evidence of recurrence or metastases.
- History of radiation at the ulcer site.
- As determined by medical history, presence of one or more medical conditions including renal, hepatic, hematologic, active auto-immune or immune diseases that, in the opinion of the Investigator, would make the patient an inappropriate candidate for this ulcer healing study.
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history of known infection with Human Immunodeficiency Virus (HIV).
- Previous participation in any VF001-DP study within the past 6 months.
- Ulcer has been previously treated with tissue engineered materials (e.g., Apligraf® or Dermagraft®) or other scaffold materials (e.g., Oasis®, Matristem®) within the last 30 days prior to S1.
- Ulcer which in the opinion of the Investigator might require negative pressure ulcer therapy or hyperbaric oxygen during the course of the study.
- New York Heart Association Class III and IV congestive heart failure, as defined by the following criteria:
- Class III: Symptoms with moderate exertion
- Class IV: Symptoms at rest
- Uncontrolled diabetes mellitus, defined as Hemoglobin A1C >10% confirmed by the Investigator.
- Ulcer on the dorsum of the foot or with more than 50% of the ulcer below the malleolus is excluded.
- Known history of acromegaly.
- Any other medical or psychological condition (including relevant laboratory abnormalities at screening) that, in the opinion of the Investigator, may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient as a result of his/her participation in this clinical trial, may make patient's participation unreliable, or may interfere with study assessments. The specific justification for patients excluded under this criterion will be noted in study documents (chart notes, CRFs, etc).
- Women unwilling to use adequate birth control, if of reproductive potential and sexually active. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study.
- Pregnancy or breast-feeding.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
ILD Research Center
Carlsbad, California, 92130
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599
Limb Preservation Platform, Inc.
Fresno, California, 93721
Alliance Research Centers
Laguna Hills, California, 24012
Advanced Foot and Ankle Center
Las Vegas, Nevada, 89119
Foot and Ankle Clinic
Los Angeles, California, 90057
Center for Clinical Research
Martinez, California, 94553
University of Miami Hospital
Miami, Florida, 33136
Doctor Research Network (Dr Hanft)
Miami, Florida, 33143
Miami Dade Medical Research Center (Dr Oliva)
Miami, Florida, 33176
Spotlight Research Centre
Miami, Florida, 33176
Barry University School of Podiatric Medicine
North Miami Beach, Florida, 33169
Sacramento Foot Ankle Cente
Sacramento, California, 95628
Bay Area Foot Care
San Francisco, California, 94115
Bay Area Foot Care
San Francisco, California, 94705
NorthBay Center for Wound Care
Vacaville, California, 95687
Center for Advanced Wound Care PC
Wyomissing, Pennsylvania, 19610
About this study
Official title: A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial Comparing Two Doses of VF001-DP to Placebo as an Adjunct to Standard Care in Patients With Chronic Venous Leg Ulcers
The purpose of this study is to determine if VF001-DP improves wound healing in chronic venous leg ulcers compared to standard care only.
Read the detailed description
Objective: The objective of this study is to demonstrate the effectiveness and safety of VF001-DP as an adjunct to standard care (SC) in the treatment of chronic venous leg ulcers (VLUs) compared to Placebo with SC over the course of the 12-week Treatment Phase.
Design: This study is a multi-center, randomized, double-blind, placebo-controlled dose-response study designed to evaluate VF-001-DP as an adjunct to SC, versus Placebo and SC in the treatment of chronic VLUs. The SC therapy for VLUs is a moisture retentive ulcer dressing and multi-layer compression therapy. Mepitel® and Coban2® have been chosen to be used as SC in this trial.
The study will have three (3) phases: Screening (2 weeks), Treatment Phase (12 weeks) and Follow-Up (12 weeks).
Only patients whose study ulcer does not exhibit more than 30% change (increase or decrease) in ulcer size post-debridement between Screening Phase Visit (S1) and Treatment Phase Visit (T1) and who continue to meet eligibility criteria at T1 will be randomized to receive either the Active Treatment group (VF001-DP low or high dose plus SC) or the Control Treatment group (Placebo plus SC) in a ratio of 1:1:1.
Treatment: Eligible patients will be assigned to one of the following treatment groups:
- Placebo and SC
- VF001-DP (14 micrograms per treatment) and SC (low dose [LD])
- VF001-DP (140 micrograms per treatment) and SC (high dose [HD]).
The investigational product (IP), i.e., VF001-DP and placebo, will be supplied in 1 mL syringes each containing 0.5 mL of either VF001-DP or Placebo.
The IP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein (vitronectin, amino acids 1-64 of the human sequence and IGF-I amino acids 1-70 of the human sequence), 14 μg or 140 μg protein in 0.5 mL of Phosphate Buffered Saline, pH 7.2. VF001-DP is manufactured utilizing an expression vector system in yeast to Good Manufacturing Practice (GMP) and is not made with and does not include any products of human or animal origin.
Number of Patients: It is planned to recruit 168 patients (56 per treatment group) at 26 centres in USA for this study.
- Conditions
- Ulcer, Leg Ulcer, Varicose Ulcer, Pathologic Processes, Skin Ulcer, Skin Diseases
- Being tested
- Placebo, VF001-DP LD, VF001-DP HD
- Keywords
- Chronic Venous Leg Ulcer
- Medical subject headings
- Ulcer, Leg Ulcer, Varicose Ulcer, Pathologic Processes, Skin Ulcer, Skin Diseases, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Placebo
VF001-DP LDBiological
VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.
VF001-DP HDBiological
VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.
| Study group | Role | What they receive |
|---|---|---|
| Placebo plus Standard Care | Placebo comparator | Placebo plus Standard Care Receives: Biological: Placebo |
| VF001-DP LD plus Standard Care | Experimental | VF001-DP (14 micrograms per treatment) and Standard Care (low dose [LD]) Receives: Biological: VF001-DP LD |
| VF001-DP HD plus Standard Care | Experimental | VF001-DP (140 micrograms per treatment) and Standard Care (high dose [HD]) Receives: Biological: VF001-DP HD |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage reduction in the study ulcer area in each treatment group over the 12-week Treatment Phase.
Patient's ulcers healing rate
Measured: 12-weeks
Secondary outcomes (6)
The proportion of patients with complete study ulcer closure within the 12-week Treatment Phase
How many patient's ulcers healed?
Measured: 12-weeks
Time to complete study ulcer closure within the 12-week Treatment Phase
Time to Ulcer Healing
Measured: 12-weeks
Time to first instance of no study ulcer pain (i.e., pain score less than 5 mm on Visual Analog Scale [VAS]) within the 12-week Treatment Phase
Measure of pain reduction to no pain
Measured: 12-weeks
Time to clinically meaningful study ulcer pain reduction (33% reduction on VAS) within the 12-week Treatment Phase
Measure of meaningful pain reduction
Measured: 12-weeks
Change in Quality-of-Life metrics Euro Quality-of-Life Questionnaire EQ-5D-5L
Quality of life
Measured: Up to 24-weeks
Change in Quality-of-Life metrics Patient Benefit Index - wound version PBI-W
Quality of life - specific to chronic wounds
Measured: Up to 24-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UlcerStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Factor Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel, ARANZ Medical, ALMAC Clinical Services
- Responsible party
- Sponsor
- Investigators
- William Marston, MD, Principal investigator, UNC-Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973893
- Sponsor's protocol ID
- VF00102
- Status last verified
- Sep 2018
- First submitted
- 7 Nov 2016
- Last updated
- 25 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Trial Comparing Two Doses of VF001-DP to Placebo as an Adjunct to Standard Care in Patients With Chronic Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT02973893
- Acronym / sponsor ID
- VF00102
- Conditions
- Ulcer, Leg Ulcer, Varicose Ulcer, Pathologic Processes, Skin Ulcer, Skin Diseases
- Keywords
- Chronic Venous Leg Ulcer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Factor Therapeutics Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Parexel, ARANZ Medical, ALMAC Clinical Services
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 25 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 purpose of this study is to determine if VF001-DP improves wound healing in chronic venous leg ulcers compared to standard care only.
Detailed description
Objective: The objective of this study is to demonstrate the effectiveness and safety of VF001-DP as an adjunct to standard care (SC) in the treatment of chronic venous leg ulcers (VLUs) compared to Placebo with SC over the course of the 12-week Treatment Phase.
Design: This study is a multi-center, randomized, double-blind, placebo-controlled dose-response study designed to evaluate VF-001-DP as an adjunct to SC, versus Placebo and SC in the treatment of chronic VLUs. The SC therapy for VLUs is a moisture retentive ulcer dressing and multi-layer compression therapy. Mepitel® and Coban2® have been chosen to be used as SC in this trial.
The study will have three (3) phases: Screening (2 weeks), Treatment Phase (12 weeks) and Follow-Up (12 weeks).
Only patients whose study ulcer does not exhibit more than 30% change (increase or decrease) in ulcer size post-debridement between Screening Phase Visit (S1) and Treatment Phase Visit (T1) and who continue to meet eligibility criteria at T1 will be randomized to receive either the Active Treatment group (VF001-DP low or high dose plus SC) or the Control Treatment group (Placebo plus SC) in a ratio of 1:1:1.
Treatment: Eligible patients will be assigned to one of the following treatment groups:
- Placebo and SC
- VF001-DP (14 micrograms per treatment) and SC (low dose [LD])
- VF001-DP (140 micrograms per treatment) and SC (high dose [HD]).
The investigational product (IP), i.e., VF001-DP and placebo, will be supplied in 1 mL syringes each containing 0.5 mL of either VF001-DP or Placebo.
The IP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein (vitronectin, amino acids 1-64 of the human sequence and IGF-I amino acids 1-70 of the human sequence), 14 μg or 140 μg protein in 0.5 mL of Phosphate Buffered Saline, pH 7.2. VF001-DP is manufactured utilizing an expression vector system in yeast to Good Manufacturing Practice (GMP) and is not made with and does not include any products of human or animal origin.
Number of Patients: It is planned to recruit 168 patients (56 per treatment group) at 26 centres in USA for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo plus Standard Care | Placebo comparator | Biological: PlaceboPlacebo plus Standard Care |
| VF001-DP LD plus Standard Care | Experimental | Biological: VF001-DP LDVF001-DP (14 micrograms per treatment) and Standard Care (low dose [LD]) |
| VF001-DP HD plus Standard Care | Experimental | Biological: VF001-DP HDVF001-DP (140 micrograms per treatment) and Standard Care (high dose [HD]) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- At least 18 years old.
- Ankle-Brachial Pressure Index (ABI) ≥0.80. (Calculations will be made using measurements from both posterior tibial and dorsalis pedis arteries as well as both arms).
- Presence of VLUs extending through the full thickness of the skin but not down to muscle, tendon or bone. In the case of more than one ulcer, the largest ulcer (compliant with study criteria) will be chosen as the study ulcer and treated in the study. Other ulcerations, if present on the same leg must be at least 2 cm apart from the study ulcer.
- Venous disease confirmed by Doppler ultrasonography to demonstrate reflux of >0.5 seconds in saphenous (great or small), calf perforators or the deep venous system. Patients with prior venous surgery (i.e., varicose vein stripping, endovenous ablation) may be included if they still demonstrate significant reflux in a remaining venous segment and the ulcer continues to suffer poor healing because of venous hypertension.
- Ulcer which has been present and treated with standard care (moisture retentive ulcer dressings and compression bandaging not limited to Mepitel® and Coban2®) for at least one month prior to the initial Screening Visit.
Key exclusion criteria (26 listed)
- Ulcer(s) deemed by the Investigator to be caused by a medical condition other than venous insufficiency. These may include, but are not limited to: fungal ulcerations, malignant ulcerations, diabetic (neuropathic) ulcerations, and ulcerations due to arterial insufficiency.
- Increase or decrease by >30% in the study ulcer surface area at the T1 visit post-debridement as compared to the S1 visit study ulcer surface area post-debridement.
- Ulcer exhibits clinical signs and symptoms of infection at S1to T1 in which case infection should be treated and the patient may after treatment be re-assessed for eligibility to enter into the study.
- Known allergy to any of the protocol-stipulated treatment procedures, or non-tolerance of multi-layer compression therapy.
- Ulcer which has undergone continuing high level of compression therapy for ≥12 months
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 |
|---|---|---|
| PlaceboPlacebo | Biological | Placebo plus Standard Care |
| VF001-DP LDVF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein. | Biological | VF001-DP LD plus Standard Care |
| VF001-DP HDVF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein. | Biological | VF001-DP HD plus Standard Care |
Primary outcome
The percentage reduction in the study ulcer area in each treatment group over the 12-week Treatment Phase.
Time frame: 12-weeks
Patient's ulcers healing rate
6 secondary outcomes
The proportion of patients with complete study ulcer closure within the 12-week Treatment Phase
Time frame: 12-weeks
Time to complete study ulcer closure within the 12-week Treatment Phase
Time frame: 12-weeks
Time to first instance of no study ulcer pain (i.e., pain score less than 5 mm on Visual Analog Scale [VAS]) within the 12-week Treatment Phase
Time frame: 12-weeks
Time to clinically meaningful study ulcer pain reduction (33% reduction on VAS) within the 12-week Treatment Phase
Time frame: 12-weeks
Change in Quality-of-Life metrics Euro Quality-of-Life Questionnaire EQ-5D-5L
Time frame: Up to 24-weeks
Change in Quality-of-Life metrics Patient Benefit Index - wound version PBI-W
Time frame: Up to 24-weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Individual participant dataSharing planned: Yes
Related trials for Ulcer
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruitingPhase 3
Study to Evaluate the Efficacy and Safety of Ilaprazole 10 mg in Prevention NSAIDs Associated Peptic Ulcer
Peptic Ulcer
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
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.
William Marston, MD principal investigator
UNC-Chapel Hill
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VF001-DP LD and VF001-DP HD in people with Ulcer and Leg Ulcer, run by Factor Therapeutics Ltd. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
Results are not available in the source record.
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?
The percentage reduction in the study ulcer area in each treatment group over the 12-week Treatment Phase. (time frame: 12-weeks). 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 25 Sep 2018.