Moderately Active Ulcerative ColitisPhase 1/2NCT00729872
A Phase 2a Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011 in Ulcerative Colitis
A Phase 1/2 study testing AG011 in people with Moderately Active Ulcerative Colitis, run by ActoGeniX N.V. at 18 sites in 4 countries.
Trial summary
The purpose of this study is to verify the safety and tolerability of AG011 (genetically modified L. lactis that has been engineered to secrete human Interleukin-10), and to determine whether AG011 can successfully treat the symptoms of moderately active Ulcerative Colitis (UC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderately Active Ulcerative Colitis
- What is being tested?
- AG011
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 18 sitesin 4 countries
- Study dates
- Jul 2008to Sep 2009
- Phase
- Phase 1/2
- 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
- Male or non-pregnant, non-lactating females, 18 years of age or older. Females of child bearing potential must have negative serum or urine pregnancy tests at the screening visit and throughout the study, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the case report form (i.e. tubal ligation, hysterectomy, or post menopausal [defined as a minimum of one year since the last menstrual period]).
- Documented diagnosis of UC with a minimum disease extent of 15 cm from the anal verge.
- Presence of friability on endoscopy, with minimum of Grade 2 (modified Baron score) changes at approximately 15 cm or more from the anal verge.
- Minimum Mayo Clinic Disease Activity Score of 5, with a score of at least 1 on both the stool frequency and rectal bleeding components.
- Receiving 5-ASA treatment for at least two months and a stable dose of oral 5 ASA for at least two weeks prior to randomization. Concurrent treatment with prednisone, or equivalent glucocorticoid ≤ 20 mg/day is acceptable as follows: minimum dosing of 4 weeks prior to screening AND stable dose for 2 weeks prior to screening AND expected to remain on a constant dose during the trial. Use of 5-ASA compounds is not required for those subjects who have failed treatment with 5-ASA compounds, or are allergic or intolerant.
- Hepatic function (AST, ALT, total bilirubin, alkaline phosphatase, LDH) ≤ 2 times the upper limit of the normal range.
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- Adequate renal function, as evidenced by serum creatinine ≤ 1.5 times the upper limit of the normal range.
- Hemoglobin ≥ 10 g/dL.
- ANC ≥ 1.5 x 10E9/L (1,500 mm3).
- Lymphocyte count ≥ 0.1 x 10E3/μL.
- Platelet count ≥ 100 x 10E9/L (100,000/mm3).
- Ability of subject to participate fully in all aspects of this clinical trial.
- Written informed consent must be obtained and documented.
Who cannot join
- Exhibiting severe ulcerative colitis as defined by the following criteria: ≥ 6 bloody stools daily with one or more of the following: oral temperature > 37.8 °C or > 100.0 °F, pulse > 90/min, hemoglobin < 10 g/dL.
- Crohn's disease.
- History of colectomy or partial colectomy.
- Clostridium (C.) difficile positive at screening visit or treated for C. difficile within the 4 weeks prior to randomization
- Treatment with antibiotics or probiotics at screening
- Treatment with cyclosporine, methotrexate, azathioprine, 6-MP, infliximab, adalimumab or other immunosuppressants/biologics within 4 weeks prior to randomization
Show all 17Show fewer
- Use of rectal steroids or 5-ASA enemas within 2 weeks prior to randomization.
- Clinically significant active infection.
- Known chronic liver disease.
- Serious underlying disease other than UC in the opinion of the investigator.
- Alcohol or illicit drug consumption, which in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures
- Active psychiatric problems, which in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.
- History of malignancy other than basal or squamous cell cancer of the skin that has been removed, or carcinoma in situ of the cervix that has been adequately treated.
- History of dysplasia in colonic biopsies.
- Receiving any investigational therapy or any approved therapy for investigational use within 30 days or 5 half-lives prior to randomization (whichever is longer).
- Pregnant or lactating women.
- Prior enrollment in the current study and had received study treatment.
Trial locations and contacts
18 sites in 4 countries.
18 sites in 4 countries
Canada8 sites
Hotel Dieu Hospital
Kingston, Ontario
LHSC - South Street Campus
London, Ontario, N6A 4G5
LHSC - University Campus
London, Ontario, N6A 5A5
Ottawa Hospital General Campus
Ottawa, Ontario
Hôpital St-Sacrement
Québec, Quebec, G1S 4L8
Mount Sinai Hospital
Toronto, Ontario
GI Research Institute
Vancouver, British Columbia, V6Z 2K5
The office of Dr. Donald Daly
Victoria, British Columbia
Belgium6 sites
Imelda Bonheiden
Bonheiden, B-2820
UCL St. Luc
Brussels
UZ Antwerpen
Edegem, B-2650
UZ Gent
Ghent, B-9000
AZ Groeninge Campus St.-Niklaas
Kortrijk
UZ Leuven
Leuven, B-3000
Sweden3 sites
Lund University Hospital
Lund, SE-221 85
Orebro University Hospital
Örebro, SE-701 85
Sophiahemmet
Stockholm, SE- 114 86
About this study
Official title: A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects With Moderately Active Ulcerative Colitis
The purpose of this study is to verify the safety and tolerability of AG011 (genetically modified L. lactis that has been engineered to secrete human Interleukin-10), and to determine whether AG011 can successfully treat the symptoms of moderately active Ulcerative Colitis (UC).
Read the detailed description
The purpose of this study is to verify the safety and tolerability of AG011 and to determine whether AG011 can successfully treat the symptoms of Ulcerative Colitis (UC). Three different dosages will be used in reference to a placebo.
AG011 is an experimental medication. It has been developed as potential treatment for moderately active UC.
AG011 is the clinical formulation of a genetically modified L. lactis that has been engineered to secrete human Interleukin-10 (hIL-10). By delivering hIL-10 locally at inflamed tissue in the intestine, it is believed that, compared to hIL-10 given by injection, the effectiveness may be increased, with fewer adverse effects.
Study medication will be provided in capsule and enema (topical rectal application) forms by ActoGeniX NV.
Subjects will be entered sequentially into one of three dose groups, starting from the lowest dose group. Within each of the first two dose groups, 15 subjects will be entered. Within the highest dose group, 30 subjects will be entered. Within each dose group, subjects will be randomly assigned in a 2:1 ratio to receive either AG011 or placebo for 28 days.
Timely monitoring of safety data is planned for the study, such that subject enrollment can continue without interruption for the purpose of data collection between dose groups. Safety and tolerability will be closely monitored by the Clinical Safety Specialist (CSS) assigned to the study. The CSS will review adverse events and laboratory safety data and report any safety concerns to the Sponsor and a Data Safety Monitoring Committee (DSMC).
At least 8 subjects must have safely completed study treatment for 28 days at a specific dose level, prior to escalation to the next dose group. The DSMC will convene to assess safety data when 8 subjects have completed study treatment for 28 days at the specific dose level. The role of the DSMC for the study will be complete when all subjects in the study have completed study treatment.
For those patients randomized within the active group, UC symptoms could improve. As a result of the information gathered by this study, the knowledge and understanding of UC could improve.
- Conditions
- Moderately Active Ulcerative Colitis
- Being tested
- AG011, Placebo
- Keywords
- AG011, Ulcerative Colitis, human Interleukin-10
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG011Biological
Capsules (low, mid or high dose), twice daily for 28 days, combined with Enema (low, mid or high dose respectively), once daily for 28 days.
PlaceboOther
Capsules (matching placebo for low, mid or high dose), twice daily for 28 days, combined with Enema (matching placebo for low, mid or high dose respectively), once daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AG011: low dose Receives: Biological: AG011 |
| 2 | Placebo comparator | Placebo: low dose Receives: Other: Placebo |
| 3 | Experimental | AG011: mid dose Receives: Biological: AG011 |
| 4 | Placebo comparator | Placebo: mid dose Receives: Other: Placebo |
| 5 | Experimental | AG011: high dose Receives: Biological: AG011 |
| 6 | Placebo comparator | Placebo: high dose Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAFETY: Adverse Events
Measured: day 1, 8 15, 22, 29, 57
SAFETY: Physical Examination (complete or brief)
Measured: day -7, 1, 8, 15, 22, 29
SAFETY: Vital signs
Measured: day -7, 1, 8, 15, 22, 29, 57
SAFETY: Clinical Laboratory Tests (hematology, serum chemistry, urinalysis)
Measured: day -7, 1, 8, 15, 22, 29, 57
SAFETY: Analysis of hIL-10 (systemic exposure) and anti-hIL-10 antibodies (immunogenicity) in plasma
Measured: day 1, day 29
SAFETY: Stool Diary
Measured: From day -7 until day 29
SAFETY: Other Safety Measures (Stool samples for culture, ova and parasite evaluation and Clostridium difficile assay.
Measured: day -7
BIOLOGICAL CONTAINMENT: Evaluation of living, genetically modified micro-organisms in stool samples
Measured: day 1, 8, 36
PHARMACODYNAMICS: Biomarkers in blood and colon biopsy samples
Measured: day -7, 29
Secondary outcomes (4)
EFFICACY: Flexible sigmoidoscopy (assessment of inflammation)
Measured: Day -7, 29
EFFICACY: Histological assessment of inflammation (biopsy samples)
Measured: Day -7, 29
EFFICACY: Disease activity assessments (MCDAS, UCCS, Investigator and Subject Global Ratings)
Measured: Day -7, 1, 8, 15, 22, 29, 57
EFFICACY: Laboratory assessments (CRP and fecal calprotectin)
Measured: Day 1, 15, 29, 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Moderately Active Ulcerative ColitisStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ActoGeniX N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bernard Coulie, MD PhD, Study chair, Chief Medical Officer ActoGeniX NVAnnegret Van der Aa, PhD, Study director, Project Manager ActoGeniX NVSeverine Vermeire, MD PhD, Principal investigator, UZ Leuven, BelgiumGeert D'Haens, MD PhD, Principal investigator, Imelda Bonheiden, BelgiumMartine De Vos, MD PhD, Principal investigator, University Hospital, GhentTom Moreels, MD PhD, Principal investigator, UZ Antwerpen, BelgiumDaan Hommes, MD PhD, Principal investigator, Leiden University Medical CenterErik Hertervig, MD PhD, Principal investigator, Lund University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00729872
- Sponsor's protocol ID
- AG011-MDUC-201
- Status last verified
- Sep 2009
- First submitted
- 4 Aug 2008
- Last updated
- 10 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Braat H, Rottiers P, Hommes DW, Huyghebaert N, Remaut E, Remon JP, van Deventer SJ, Neirynck S, Peppelenbosch MP, Steidler L. A phase I trial with transgenic bacteria expressing interleukin-10 in Crohn's disease. Clin Gastroenterol Hepatol. 2006 Jun;4(6):754-9. doi: 10.1016/j.cgh.2006.03.028. Epub 2006 May 22.
PubMed 16716759Robert S, Steidler L. Recombinant Lactococcus lactis can make the difference in antigen-specific immune tolerance induction, the Type 1 Diabetes case. Microb Cell Fact. 2014 Aug 29;13 Suppl 1(Suppl 1):S11. doi: 10.1186/1475-2859-13-S1-S11. Epub 2014 Aug 29.
PubMed 25185797
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Randomized, Placebo-Controlled, Double-Blind, Multi-Center Dose Escalation Study, to Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of AG011, in Subjects With Moderately Active Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00729872
- Acronym / sponsor ID
- AG011-MDUC-201
- Conditions
- Moderately Active Ulcerative Colitis
- Keywords
- AG011, Ulcerative Colitis, human Interleukin-10
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ActoGeniX N.V.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 8 Aug 2008 (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 verify the safety and tolerability of AG011 (genetically modified L. lactis that has been engineered to secrete human Interleukin-10), and to determine whether AG011 can successfully treat the symptoms of moderately active Ulcerative Colitis (UC).
Detailed description
The purpose of this study is to verify the safety and tolerability of AG011 and to determine whether AG011 can successfully treat the symptoms of Ulcerative Colitis (UC). Three different dosages will be used in reference to a placebo.
AG011 is an experimental medication. It has been developed as potential treatment for moderately active UC.
AG011 is the clinical formulation of a genetically modified L. lactis that has been engineered to secrete human Interleukin-10 (hIL-10). By delivering hIL-10 locally at inflamed tissue in the intestine, it is believed that, compared to hIL-10 given by injection, the effectiveness may be increased, with fewer adverse effects.
Study medication will be provided in capsule and enema (topical rectal application) forms by ActoGeniX NV.
Subjects will be entered sequentially into one of three dose groups, starting from the lowest dose group. Within each of the first two dose groups, 15 subjects will be entered. Within the highest dose group, 30 subjects will be entered. Within each dose group, subjects will be randomly assigned in a 2:1 ratio to receive either AG011 or placebo for 28 days.
Timely monitoring of safety data is planned for the study, such that subject enrollment can continue without interruption for the purpose of data collection between dose groups. Safety and tolerability will be closely monitored by the Clinical Safety Specialist (CSS) assigned to the study. The CSS will review adverse events and laboratory safety data and report any safety concerns to the Sponsor and a Data Safety Monitoring Committee (DSMC).
At least 8 subjects must have safely completed study treatment for 28 days at a specific dose level, prior to escalation to the next dose group. The DSMC will convene to assess safety data when 8 subjects have completed study treatment for 28 days at the specific dose level. The role of the DSMC for the study will be complete when all subjects in the study have completed study treatment.
For those patients randomized within the active group, UC symptoms could improve. As a result of the information gathered by this study, the knowledge and understanding of UC could improve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: AG011AG011: low dose |
| 2 | Placebo comparator | Other: PlaceboPlacebo: low dose |
| 3 | Experimental | Biological: AG011AG011: mid dose |
| 4 | Placebo comparator | Other: PlaceboPlacebo: mid dose |
| 5 | Experimental | Biological: AG011AG011: high dose |
| 6 | Placebo comparator | Other: PlaceboPlacebo: high dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or non-pregnant, non-lactating females, 18 years of age or older. Females of child bearing potential must have negative serum or urine pregnancy tests at the screening visit and throughout the study, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the case report form (i.e. tubal ligation, hysterectomy, or post menopausal [defined as a minimum of one year since the last menstrual period]).
- Documented diagnosis of UC with a minimum disease extent of 15 cm from the anal verge.
- Presence of friability on endoscopy, with minimum of Grade 2 (modified Baron score) changes at approximately 15 cm or more from the anal verge.
- Minimum Mayo Clinic Disease Activity Score of 5, with a score of at least 1 on both the stool frequency and rectal bleeding components.
- Receiving 5-ASA treatment for at least two months and a stable dose of oral 5 ASA for at least two weeks prior to randomization. Concurrent treatment with prednisone, or equivalent glucocorticoid ≤ 20 mg/day is acceptable as follows: minimum dosing of 4 weeks prior to screening AND stable dose for 2 weeks prior to screening AND expected to remain on a constant dose during the trial. Use of 5-ASA compounds is not required for those subjects who have failed treatment with 5-ASA compounds, or are allergic or intolerant.
Key exclusion criteria (17 listed)
- Exhibiting severe ulcerative colitis as defined by the following criteria: ≥ 6 bloody stools daily with one or more of the following: oral temperature > 37.8 °C or > 100.0 °F, pulse > 90/min, hemoglobin < 10 g/dL.
- Crohn's disease.
- History of colectomy or partial colectomy.
- Clostridium (C.) difficile positive at screening visit or treated for C. difficile within the 4 weeks prior to randomization
- Treatment with antibiotics or probiotics 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 |
|---|---|---|
| AG011Capsules (low, mid or high dose), twice daily for 28 days, combined with Enema (low, mid or high dose respectively), once daily for 28 days. | Biological | 1, 3, 5 |
| PlaceboCapsules (matching placebo for low, mid or high dose), twice daily for 28 days, combined with Enema (matching placebo for low, mid or high dose respectively), once daily for 28 days. | Other | 2, 4, 6 |
Primary outcome
SAFETY: Adverse Events
Time frame: day 1, 8 15, 22, 29, 57
SAFETY: Physical Examination (complete or brief)
Time frame: day -7, 1, 8, 15, 22, 29
SAFETY: Vital signs
Time frame: day -7, 1, 8, 15, 22, 29, 57
SAFETY: Clinical Laboratory Tests (hematology, serum chemistry, urinalysis)
Time frame: day -7, 1, 8, 15, 22, 29, 57
SAFETY: Analysis of hIL-10 (systemic exposure) and anti-hIL-10 antibodies (immunogenicity) in plasma
Time frame: day 1, day 29
SAFETY: Stool Diary
Time frame: From day -7 until day 29
SAFETY: Other Safety Measures (Stool samples for culture, ova and parasite evaluation and Clostridium difficile assay.
Time frame: day -7
BIOLOGICAL CONTAINMENT: Evaluation of living, genetically modified micro-organisms in stool samples
Time frame: day 1, 8, 36
PHARMACODYNAMICS: Biomarkers in blood and colon biopsy samples
Time frame: day -7, 29
4 secondary outcomes
EFFICACY: Flexible sigmoidoscopy (assessment of inflammation)
Time frame: Day -7, 29
EFFICACY: Histological assessment of inflammation (biopsy samples)
Time frame: Day -7, 29
EFFICACY: Disease activity assessments (MCDAS, UCCS, Investigator and Subject Global Ratings)
Time frame: Day -7, 1, 8, 15, 22, 29, 57
EFFICACY: Laboratory assessments (CRP and fecal calprotectin)
Time frame: Day 1, 15, 29, 57
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 10 Sep 2009.
- Background: PubMed 16716759Braat H, Rottiers P, Hommes DW, Huyghebaert N, Remaut E, Remon JP, van Deventer SJ, Neirynck S, Peppelenbosch MP, Steidler L. A phase I trial with transgenic bacteria expressing interleukin-10 in Crohn's disease. Clin Gastroenterol Hepatol. 2006 Jun;4(6):754-9. doi: 10.1016/j.cgh.2006.03.028. Epub 2006 May 22.
- Derived from this study: PubMed 25185797Robert S, Steidler L. Recombinant Lactococcus lactis can make the difference in antigen-specific immune tolerance induction, the Type 1 Diabetes case. Microb Cell Fact. 2014 Aug 29;13 Suppl 1(Suppl 1):S11. doi: 10.1186/1475-2859-13-S1-S11. Epub 2014 Aug 29.
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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.
Bernard Coulie, MD PhD study chair
Chief Medical Officer ActoGeniX NV
Annegret Van der Aa, PhD study director
Project Manager ActoGeniX NV
Severine Vermeire, MD PhD principal investigator
UZ Leuven, Belgium
18 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AG011 in people with Moderately Active Ulcerative Colitis, run by ActoGeniX N.V. at 18 sites in 4 countries.
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 13 inclusion and 17 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 10 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Canada, Belgium, Sweden, Netherlands. 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 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?
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?
SAFETY: Adverse Events (time frame: day 1, 8 15, 22, 29, 57). The study lists 9 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 NCT00729872, which also lists 2 linked publications.
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 10 Sep 2009.