HemorrhagePhase 1NCT01955720

Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran

A Phase 1 study testing BI 655075 in people with Hemorrhage, run by Boehringer Ingelheim at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075 dose(s) effective to reverse prolongation of blood coagulation time by dabigatran Read more about this study

Who is it for?: Ages 45 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Hemorrhage
What is being tested?: BI 655075
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 1 siteBelgium
Study dates: Sep 2013to Aug 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy midage male and female volunteers, age =45 and =64 years, BMI range: =18.5 and =29.9 kg/m2
Healthy elderly male and female volunteers, age =65 and =80 years, BMI range: =18.5 and = 32 kg/m2
Male and female volunteers with mild renal impairment (CLcrd 60-90 (mL/min)) in relatively good health, age =45 and =80 years, BMI range: =18.5 and =32 kg/m2 Moderate renal impaired (CLcrd =30 to <60 mL/min according Cockcroft\&Gault formula in relatively good health, age =45 and =80 years, BMI range: =18.5 and =32 kg/m2

Who cannot join

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease (other than mild renal impairment in the respective group) A significant disease is defined as a disease which in the opinion of the investigator
put the volunteer at risk because of participation in the study
may influence the results of the study
may influence the volunteer¿s ability to participate in the study
is not in a stable condition Diabetic, hypercholesterolemia or hypertensive subjects can be entered in this trial if the disease is not significant according to these criteria

Show all 11Show fewer

Surgery of the gastrointestinal tract (except appendectomy)
Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
History of relevant orthostatic hypotension, fainting spells or blackouts.
Chronic or relevant acute infections
History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)

Trial locations and contacts

1 site in 1 country.

Belgium1 site

1321.2.1 Boehringer Ingelheim Investigational Site
Antwerp

Other trials in Belgium

About this study

Official title: Randomised, Double-blind, Placebo-controlled, Two-way Cross-over Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655075 and to Establish the Efficacy of BI 655075 in Reversal of Dabigatran Anticoagulant Activity in Volunteers

To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075 dose(s) effective to reverse prolongation of blood coagulation time by dabigatran

Conditions: Hemorrhage
Being tested: BI 655075, Placebo
Medical subject headings: Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 655075Drug
BI 655075Drug
PlaceboDrug
BI 655075Drug
PlaceboDrug
PlaceboDrug
PlaceboDrug
BI 655075Drug

Study groups in NCT01955720
Study group	Role	What they receive
healthy subjects aged 45-64	Experimental	Sequential Crossover to Placebo or BI 655075 Receives: Drug: BI 655075; Drug: Placebo
healthy elderly subjects aged 65-80 year	Experimental	Sequential Crossover to Placebo or BI 655075 Receives: Drug: BI 655075; Drug: Placebo
mild renal impairment aged 45-80 years	Experimental	Sequential Crossover to Placebo or BI 655075 Receives: Drug: BI 655075; Drug: Placebo
mod renal impairment aged 45-80 years	Experimental	Sequential Crossover to Placebo or BI 655075 Receives: Drug: Placebo; Drug: BI 655075

What is being measured

The primary outcome is the main question the study is designed to answer.

Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time
Percentage of subjects with at least one assay value from diluted thrombin time (dTT) or ecarin clotting time (ECT) reversed within 10min after completion of infusion. Reversal was defined as return to baseline, where the threshold for reversal to baseline was determined using PK/PD correlation between unbound sum dabigatran and the clotting parameters ECT and dTT. Measured at the end of the infusion and 10 min later.
Measured: End of last infusion and 10 minutes after completion of last infusion of BI 655075
The Percentage of Subjects With Drug-related Adverse Events
The percentage of subjects with possibly drug-related AEs (as defined by the investigator) during the treatment period.
Measured: From baseline up to the start of follow-up period (from Day 1 to Day 35)

Secondary outcomes (5)

AUC0-infinity (Area Under the Concentration-time Curve of Idarucizumab (Ida) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
AUC0-infinity. PK/PD sampling time: (p=predose, D=day)
1. single medium or high dose, healthy subjects(HS) mid-age (45-64 yrs): D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00p, 21:00. D6: 9:00.
2. single low or high dose, HS elderly or mild renal impaired: D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for renal impaired: D8: 9:00;D9: 9:00.
3. high 2 doses, moderate renal impaired: D4: 8:55p, 9:00, 9:10,9:30,9:55p, 10:00,10:10,10:30,11:00, 13:00, 15:00, 19:00, 21:00, 01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for renal impaired: D8:9:00; D9:9:00.
Measured: From Day 4 to Day 9 (details in description)
AUC2-12, ss (Area Under the Concentration-time Curve of Unbound Sum Dabigatran (DE) in Plasma at Steady State Over the Time Interval From 2 to 12h)
PK/PD sampling time:(d=dose,D=Day,p=predose)
1. single medium or high dose,healthy, mid-age (45-64 yrs): D4: 7:00p,8:55p,9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00, 01:00; D5:9:00p,11:00,21:00p; D6:9:00p, 21:00p; D7:9:00p, 11:00.
2. single low or high dose,healthy elder or mild renal impaired: D4:7:00p,8:55p,9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00;D5:9:00;D6:9:00;D7:9:00; additional sampling for renal impaired: D8:9:00;D9:9:00.
3. high 2 doses, moderate renal impaired: D4:7:00p,8:55p,9:00,9:10,9:30,9:55p,10:00,10:10,10:30,11:00,13:00,15:00,19:00,21:00,01:00;D5:9:00;D6:9:00; D7:9:00; additional sampling for renal impaired: D8:9:00;D9:9:00.
Measured: from 2h to12h of post DE dose at steady state (details in description)
Aet1-t2, ss (Amount of DE Eliminated in Urine From the Time Point t1 to Time Point t2)
Urinary excretion of sum dabigatran from the time point t1 to t2 at steady state.
PK Urine sampling time:
Urine sampling relative to first DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h.
Ae0-26,ss was not measured in Period 3 (re-exposure period). Ae0-74,ss was not measured in healthy subjects aged 45 to 64 years.
Measured: From 0 to 74h post of last DE dose (details in description)
Cmax (Maximum Measured Concentration of the Ida in Plasma)
Cmax. PK/PD sampling time: (p=predose, D=day)
1. single medium or high dose, HS mid-age (45-64 yrs): D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00p, 21:00. D6: 9:00.
2. single low or high dose, healthy elderly or mild RI: D4: 8:55p, 9:00,9:10,9:30,10:00,11:00,13:00,15:00,19:00,21:00,01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for RI: D8: 9:00;D9: 9:00.
3. high 2 doses, moderate RI: D4: 8:55p, 9:00, 9:10,9:30,9:55p, 10:00,10:10,10:30,11:00, 13:00, 15:00, 19:00, 21:00, 01:00; D5: 9:00; D6: 9:00; D7: 9:00; additional sampling for RI: D8:9:00; D9:9:00.
Measured: From Ida administration to 4 days post dose (details in description)
Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time Point 6 h)
Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time point 6 h).
PK Urine sampling time:
Urine sampling relative to DE administration: Planned times 72:00 - 73:55h, 73:55 - 80:00h, 80:00 - 86:00h, 86:00 - 98:00h, 98:00 - 122:00h, 122:00 - 146:00h; additional sampling for renal impaired: 146:00 - 170:00; 170:00 - 194:00h.
Measured: from 0 to 6 hours of post Ida dose (details in description)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Aug 2014

First posted7 Oct 2013 (estimated)
Study startSep 2013
Primary completionMay 2014
Study completionAug 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for HemorrhageStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
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: Randomised
Intervention model: Crossover
Masking: Double blind
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01955720
Sponsor's protocol ID: 1321.2
Other IDs: 2013-003616-52
Status last verified: Jan 2016
First submitted: 30 Sep 2013
Last updated: 11 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

Publications

Norris S, Ramael S, Ikushima I, Haazen W, Harada A, Moschetti V, Imazu S, Reilly PA, Lang B, Stangier J, Glund S. Evaluation of the immunogenicity of the dabigatran reversal agent idarucizumab during Phase I studies. Br J Clin Pharmacol. 2017 Aug;83(8):1815-1825. doi: 10.1111/bcp.13269. Epub 2017 Apr 6.
PubMed 28230262
Glund S, Stangier J, van Ryn J, Schmohl M, Moschetti V, Haazen W, De Smet M, Gansser D, Norris S, Lang B, Reilly P, Kreuzer J. Effect of Age and Renal Function on Idarucizumab Pharmacokinetics and Idarucizumab-Mediated Reversal of Dabigatran Anticoagulant Activity in a Randomized, Double-Blind, Crossover Phase Ib Study. Clin Pharmacokinet. 2017 Jan;56(1):41-54. doi: 10.1007/s40262-016-0417-0.
PubMed 27317414
Glund S, Stangier J, van Ryn J, Schmohl M, Moschetti V, Haazen W, De Smet M, Gansser D, Norris S, Lang B, Reilly P, Kreuzer J. Restarting Dabigatran Etexilate 24 h After Reversal With Idarucizumab and Redosing Idarucizumab in Healthy Volunteers. J Am Coll Cardiol. 2016 Apr 5;67(13):1654-1656. doi: 10.1016/j.jacc.2016.01.043. No abstract available.
PubMed 27150693

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomised, Double-blind, Placebo-controlled, Two-way Cross-over Phase Ib Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655075 and to Establish the Efficacy of BI 655075 in Reversal of Dabigatran Anticoagulant Activity in Volunteers
ClinicalTrials.gov ID: NCT01955720
Acronym / sponsor ID: 1321.2
Conditions: Hemorrhage
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 46 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: May 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 7 Oct 2013 (estimated)
Results: Posted 11 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To investigate safety, tolerability, PK and PD of BI 655075 and to establish the BI 655075 dose(s) effective to reverse prolongation of blood coagulation time by dabigatran

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Number of arms: 4

Arm	Type	Receives
healthy subjects aged 45-64	Experimental	Drug: BI 655075, Drug: PlaceboSequential Crossover to Placebo or BI 655075
healthy elderly subjects aged 65-80 year	Experimental	Drug: BI 655075, Drug: PlaceboSequential Crossover to Placebo or BI 655075
mild renal impairment aged 45-80 years	Experimental	Drug: BI 655075, Drug: PlaceboSequential Crossover to Placebo or BI 655075
mod renal impairment aged 45-80 years	Experimental	Drug: Placebo, Drug: BI 655075Sequential Crossover to Placebo or BI 655075

Who may qualify

Ages: 45 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Healthy midage male and female volunteers, age =45 and =64 years, BMI range: =18.5 and =29.9 kg/m2
Healthy elderly male and female volunteers, age =65 and =80 years, BMI range: =18.5 and = 32 kg/m2
Male and female volunteers with mild renal impairment (CLcrd 60-90 (mL/min)) in relatively good health, age =45 and =80 years, BMI range: =18.5 and =32 kg/m2 Moderate renal impaired (CLcrd =30 to <60 mL/min according Cockcroft\&Gault formula in relatively good health, age =45 and =80 years, BMI range: =18.5 and =32 kg/m2

Key exclusion criteria (11 listed)

Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
Any evidence of a clinically relevant concomitant disease (other than mild renal impairment in the respective group) A significant disease is defined as a disease which in the opinion of the investigator
put the volunteer at risk because of participation in the study
may influence the results of the study
may influence the volunteer¿s ability to participate in the study

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
BI 655075	Drug	mild renal impairment aged 45-80 years
BI 655075	Drug	healthy subjects aged 45-64
Placebo	Drug	mod renal impairment aged 45-80 years
BI 655075	Drug	healthy elderly subjects aged 65-80 year
Placebo	Drug	healthy subjects aged 45-64
Placebo	Drug	healthy elderly subjects aged 65-80 year
Placebo	Drug	mild renal impairment aged 45-80 years
BI 655075	Drug	mod renal impairment aged 45-80 years

Primary outcome

Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time
Time frame: End of last infusion and 10 minutes after completion of last infusion of BI 655075
Percentage of subjects with at least one assay value from diluted thrombin time (dTT) or ecarin clotting time (ECT) reversed within 10min after completion of infusion. Reversal was defined as return to baseline, where the threshold for reversal to baseline was determined using PK/PD correlation between unbound sum dabigatran and the clotting parameters ECT and dTT. Measured at the end of the infusion and 10 min later.
The Percentage of Subjects With Drug-related Adverse Events
Time frame: From baseline up to the start of follow-up period (from Day 1 to Day 35)
The percentage of subjects with possibly drug-related AEs (as defined by the investigator) during the treatment period.

5 secondary outcomes

AUC0-infinity (Area Under the Concentration-time Curve of Idarucizumab (Ida) in Plasma Over the Time Interval From 0 Extrapolated to Infinity)
Time frame: From Day 4 to Day 9 (details in description)
AUC2-12, ss (Area Under the Concentration-time Curve of Unbound Sum Dabigatran (DE) in Plasma at Steady State Over the Time Interval From 2 to 12h)
Time frame: from 2h to12h of post DE dose at steady state (details in description)
Aet1-t2, ss (Amount of DE Eliminated in Urine From the Time Point t1 to Time Point t2)
Time frame: From 0 to 74h post of last DE dose (details in description)
Cmax (Maximum Measured Concentration of the Ida in Plasma)
Time frame: From Ida administration to 4 days post dose (details in description)
Ae0-6 (Amount of Ida Eliminated in Urine From the Time Point 0 to Time Point 6 h)
Time frame: from 0 to 6 hours of post Ida dose (details in description)

Results and safety

Results posted to the registry on 11 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
5 Ida / Placebo	13	13
Placebo / 5 Ida	13	13
2.5 Ida / Placebo	3	3
Placebo / 2.5 Ida	3	3
1 Ida / Placebo	7	7
Placebo / 1 Ida	7	7

Primary outcome: Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time

Time frame: End of last infusion and 10 minutes after completion of last infusion of BI 655075. Number. Unit: percentage of participants

Measure	Placebo n = 46	Idarucizumab (Ida) n = 46
at least one time point, dTT	0.0	100.0
both time points, dTT	0.0	100.0
at least one time point, ECT	0.0	100.0
both time points, ECT	0.0	100.0

Population analysed: PD Set (PDS): The PDS included all subjects from the TS who had at least 1 evaluable predose and on-treatment coagulation test measurement value for at least 1 coagulation test and who did not have important protocol violation relevant to the evaluation of PD.

Primary outcome: The Percentage of Subjects With Drug-related Adverse Events

Time frame: From baseline up to the start of follow-up period (from Day 1 to Day 35). Number. Unit: percentage of participants

Measure	On Treatment Group n = 46
Value	13.0

Population analysed: Treated Set (TS): All randomised subjects who received at least 1 dose of trial medication were included in the treated set.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the study drug administration up to start of follow-up period (from Day 1 to Day 35).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dabigatran Etexilate (DE)	0 of 46 (0%)	13 of 46 (28.3%)	Not reported
Low (1g) Idarucizumab Dose	0 of 14 (0%)	4 of 14 (28.6%)	Not reported
Medium (2.5g) Idarucizumab Dose	0 of 12 (0%)	1 of 12 (8.3%)	Not reported
High (5g) Idarucizumab Dose	0 of 26 (0%)	2 of 26 (7.7%)	Not reported
Low (1g) Placebo Dose	0 of 14 (0%)	3 of 14 (21.4%)	Not reported
Medium (2.5g) Placebo Dose	0 of 12 (0%)	3 of 12 (25%)	Not reported
High (5g) Placebo Dose	0 of 26 (0%)	0 of 26 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28230262Norris S, Ramael S, Ikushima I, Haazen W, Harada A, Moschetti V, Imazu S, Reilly PA, Lang B, Stangier J, Glund S. Evaluation of the immunogenicity of the dabigatran reversal agent idarucizumab during Phase I studies. Br J Clin Pharmacol. 2017 Aug;83(8):1815-1825. doi: 10.1111/bcp.13269. Epub 2017 Apr 6.
Derived from this study: PubMed 27317414Glund S, Stangier J, van Ryn J, Schmohl M, Moschetti V, Haazen W, De Smet M, Gansser D, Norris S, Lang B, Reilly P, Kreuzer J. Effect of Age and Renal Function on Idarucizumab Pharmacokinetics and Idarucizumab-Mediated Reversal of Dabigatran Anticoagulant Activity in a Randomized, Double-Blind, Crossover Phase Ib Study. Clin Pharmacokinet. 2017 Jan;56(1):41-54. doi: 10.1007/s40262-016-0417-0.
Derived from this study: PubMed 27150693Glund S, Stangier J, van Ryn J, Schmohl M, Moschetti V, Haazen W, De Smet M, Gansser D, Norris S, Lang B, Reilly P, Kreuzer J. Restarting Dabigatran Etexilate 24 h After Reversal With Idarucizumab and Redosing Idarucizumab in Healthy Volunteers. J Am Coll Cardiol. 2016 Apr 5;67(13):1654-1656. doi: 10.1016/j.jacc.2016.01.043. No abstract available.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BI 655075 in people with Hemorrhage, run by Boehringer Ingelheim at 1 site in Belgium.

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 3 inclusion and 11 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 11 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. 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?

Yes. Results are posted in the registry (first posted 11 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reversal of Dabigatran-induced Prolongation of Blood Coagulation Time (time frame: End of last infusion and 10 minutes after completion of last infusion of BI 655075). The study lists 2 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 NCT01955720, which also lists 3 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 11 Feb 2016.