HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia (HORNBILL)

April 25, 2024 updated by: Boehringer Ingelheim

A First-in Human Trial to Study Safety and Tolerability of Single Rising Intravitreal dOses (Open Label, Non-randomized, Uncontrolled) and in Addition the Early Biological Response of Multiple intravitReal Dosing (Single-masked, raNdomized, Sham-controlled) of BI 764524 in panretinaL Photocoagulation (PRP) Treated proLiferative Diabetic Retinopathy (PDR) Patients With Diabetic Macular Ischemia (DMI) - the HORNBILL Study

This is a study in people with a type of diabetic eye disease called diabetic retinopathy with diabetic macular ischemia. People who have had laser treatment for their diabetic retinopathy can participate in the study. The laser treatment is called panretinal photocoagulation.

The purpose of the study is to find out how well different doses of a medicine called BI 764524 are tolerated. BI 764524 is injected into the eye. The study has 2 parts. In the first part, participants get different doses of BI 764524 only once. Participants are in the first part for about 5 months and visit the study site about 8 times. In the second part, participants are put into different groups by chance. Some participants get BI 764524 injections every 4 weeks. Other participants get sham injections every 4 weeks. A sham injection means that it is not a real injection and contains no medicine. Participants cannot tell whether they get the real injection or a sham injection. For the second part, participants are in the study for about 7 months. During this time, they visit the study site about 7 times. In this study, BI 764524 is given to humans for the first time.

The doctors compare how well people tolerate the BI 764524 injections and the sham injections.

The doctors also regularly check the general health of the participants.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
      • Bristol, United Kingdom, BS1 2LX
        • Bristol Eye Hospital
      • Essex, United Kingdom, SS0 0RY
        • Southend University Hospital
      • Gloucester, United Kingdom, GL1 3NN
        • Gloucestershire Royal Hospital
      • London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital
      • Sunderland, United Kingdom, SR2 9HP
        • Sunderland Eye Infirmary
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Trinity Research
    • California
      • Beverly Hills, California, United States, 90211
        • Retina-Vitreous Associates Medical Group
      • Palo Alto, California, United States, 94303
        • Stanford University Medical Center
    • Florida
      • Orlando, Florida, United States, 32806
        • Florida Retina Institute
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Raj K. Maturi, MD PC
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Joslin Diabetes Center
    • New York
      • Great Neck, New York, United States, 11021
        • Long Island Vitreoretinal Consultants
      • New York, New York, United States, 10003
        • New York Eye and Ear Infirmary of Mount Sinai
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Texas
      • Austin, Texas, United States, 78705
        • Austin Research Center for Retina, PLLC
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute, PA
      • The Woodlands, Texas, United States, 77384
        • Retina Consultants of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Single rising dose (SRD) and multiple dosing (MD) part:

  • Pan-retinal photo coagulation treated proliferative diabetic retinopathy (PDR) participants with either no or inactive retinal neovascularization per investigator judgement in the study eye
  • Male or female participants of age ≥ 18 years
  • HbA1c of ≤ 12.0%

  • Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use two methods of contraception with at least one of them being a highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information and in the clinical trial protocol.

    --A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 2 years without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 2 years of menorrhea, a single FSH measurement is sufficient.

  • Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH GCP) and local legislation prior to admission to the trial

SRD part only:

  • Evidence of diabetic macular ischemia (DMI) per investigator´s judgement, defined as any degree of disruption of retinal vascularity in superficial and/or deep retinal plexus in OCTA
  • Best-corrected Visual activity (VA) in the non-study eye better than best-corrected VA in the study-eye, if both eyes are eligible and have identical VA the investigator may select the study eye.
  • Best-corrected VA ≤55 letters (20/80) or worse

MD part only:

  • Presence of significant DMI: large foveal avascular zone defined as those with ≥0.5mm2 area in superficial vascular complex (SVC) present on optical coherence tomography angiography. If FAZ is <0.5mm2 then enlarged peri-foveal inter-capillary space in at least 1 quadrant will be sufficient.
  • If both eyes are eligible, the investigator may select either eye to be the study eye.
  • Best-corrected VA ≤ 85 letters (20/20) or worse

Exclusion Criteria:

SRD part only:

  • Participants receiving intravitreal (IVT) injections for active diabetic macular edema (DME, injections: anti-vascular endothelial growth factor (VEGF), steroids) and macular laser in the study eye in the previous 3 months prior to enrolment
  • Participants receiving anti-VEGF IVT injections for active PDR in the study eye in the previous 3 months prior to enrolment
  • Current or planned use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol)
  • Additional eye disease in the study eye that could compromise best corrected VA (BCVA) with visual field loss, uncontrolled glaucoma (IOP>24), age related macular degeneration, history of ischemic optic neuropathy or retinal vascular occlusion, symptomatic vitreomacular traction, or genetic disorders such as retinitis pigmentosa; history of high myopia > 8 diopters in the study eye. Anterior segment and vitreous abnormalities in the study eye that would preclude adequate observation with SD-OCT
  • Any intraocular surgery in the study eye within 3 months prior to screening
  • Aphakia or total absence of the posterior capsule. Yttrium aluminium garnet (YAG) laser capsulotomy in the study eye if performed less than 3 months prior to enrolment
  • Participants not expected to comply with the protocol requirements or not expected to complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other condition that, in the investigator´s opinion, makes the patient an unreliable trial participant)
  • Previous participation in this trial or in other trials with IVT injections administered within 3 months.

Further exclusion criteria apply.

MD part only:

  • DME, defined as a central subfield thickness (CST) ≥305 micrometer (μm) for men and ≥290 μm women measured with optovue (Optical coherent tomography) OCT in the study eye
  • Participants receiving IVT injections for active DME (anti-VEGF, steroids) and macular laser in the study eye in the previous 3 months prior to enrolment
  • Participants receiving anti-VEGF IVT injections for active PDR in the study eye in the previous 3 months prior to enrolment
  • Heavily lasered macula in the study eye per investigator's judgement
  • History of vitrectomy in the study eye
  • Epiretinal membrane with extended foveal contour distortion in the study eye per investigator's judgement
  • Current or planned use of medications known to be toxic to the retina, lens or optic nerve (e.g. desferoximine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, nicotinic acid, and ethambutol) Further exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single-rising dose part - low dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of low dose BI 764524.
Drug: BI 764524
BI 764524
Experimental: Single-rising dose part - medium dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of medium dose BI 764524.
Drug: BI 764524
BI 764524
Experimental: Single-rising dose part - high dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received one intravitreal injection of high dose BI 764524.
Drug: BI 764524
BI 764524
Sham Comparator: Multiple dosing part - Sham
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three sham intravitreal injections, each separated by 4 weeks.
Drug: Sham control of BI 764524
Sham control of BI 764524
Experimental: Multiple dosing part - high dose BI 764524
Pan-retinal photocoagulation (PRP)-treated proliferative diabetic retinopathy (PDR) patients with diabetic macular ischaemia (DMI) received three intravitreal injections of high dose BI 764524, each separated by 4 weeks.
Drug: BI 764524
BI 764524

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Single-rising Dose (SRD) Part - The Number of Patients With Dose Limiting Events (DLEs) From Drug Administration Until Day 8
Time Frame: From drug administration (day 1) till day 8, Up to 7±2 days.
Single-rising dose (SRD) part - The number of patients with dose limiting events (DLEs) from drug administration until Day 8 (7 days after treatment).
From drug administration (day 1) till day 8, Up to 7±2 days.
Multiple Dosing (MD) Part - the Number of Patients With Drug-related Adverse Events (AEs) From Drug Administration Until End of Trial.
Time Frame: From drug administration (day 1) till End of Trial, up to 23 weeks.
Multiple dosing (MD) part - the number of patients with drug-related Adverse Events (AEs) from drug administration until End of Trial.
From drug administration (day 1) till End of Trial, up to 23 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SRD Part - Number of Patients With Drug-related Adverse Events at End of Trial
Time Frame: From drug administration (day 1) till End of Trial, up to 15 weeks.
SRD part - Number of patients with drug-related Adverse Events at End of Trial.
From drug administration (day 1) till End of Trial, up to 15 weeks.
SRD Part - Number of Patients With Ocular Adverse Events (Eye Disorders) at End of Trial
Time Frame: From drug administration (day 1) till End of Trial, up to 15 weeks.
SRD part - Number of patients with ocular Adverse Events (eye disorders) at End of Trial.
From drug administration (day 1) till End of Trial, up to 15 weeks.
MD Part - Number of Patients With Ocular Adverse Events (Eye Disorders) at End of Trial
Time Frame: From drug administration (day 1) till End of Trial, up to 23 weeks.
MD part - Number of patients with ocular Adverse Events (eye disorders) at End of Trial.
From drug administration (day 1) till End of Trial, up to 23 weeks.
MD Part - Change From Baseline of the Size of the FAZ in FTR at Visit 5
Time Frame: Baseline (day 0) and Visit 5 (day 85±7).
MD part - Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in full thickness retina (FTR) at Visit 5. Results calculated as [Baseline data]-[Visit 5 data].
Baseline (day 0) and Visit 5 (day 85±7).
MD Part - Change From Baseline of the Size of the FAZ in SVC at Visit 5
Time Frame: Baseline (day 0) and Visit 5 (day 85±7).
MD part - Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in superficial vascular complex (SVC) at Visit 5. Results calculated as [Baseline data]-[Visit 5 data].
Baseline (day 0) and Visit 5 (day 85±7).
MD Part - Change From Baseline of the Size of the FAZ in FTR at Visit 7
Time Frame: Baseline (day 0) and Visit 7 (day 155±7).
MD part - Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in full thickness retina (FTR) at Visit 7. Results calculated as [Baseline data]-[Visit 7 data].
Baseline (day 0) and Visit 7 (day 155±7).
MD Part - Change From Baseline of the Size of the FAZ in SVC at Visit 7
Time Frame: Baseline (day 0) and Visit 7 (day 155±7).
MD part - Change from baseline of the size of the foveal avascular zone (FAZ) in optical coherence tomography angiography (OCTA) in superficial vascular complex (SVC) at Visit 7. Results calculated as [Baseline data]-[Visit 7 data].
Baseline (day 0) and Visit 7 (day 155±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 3
Time Frame: Baseline (day 0) and Visit 3 (day 29±7).
Change from baseline of best corrected visual acuity (BCVA) at Visit 3. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as [Baseline data]-[Visit 3 data].
Baseline (day 0) and Visit 3 (day 29±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 4
Time Frame: Baseline (day 0) and Visit 4 (day 57±7).
Change from baseline of best corrected visual acuity (BCVA) at Visit 4. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 4 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as [Baseline data]-[Visit 4 data].
Baseline (day 0) and Visit 4 (day 57±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 5
Time Frame: Baseline (day 0) and Visit 5 (day 85±7).
Change from baseline of best corrected visual acuity (BCVA) at Visit 5. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 5 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as [Baseline data]-[Visit 5 data].
Baseline (day 0) and Visit 5 (day 85±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 6
Time Frame: Baseline (day 0) and Visit 6 (day 113±7).
Change from baseline of best corrected visual acuity (BCVA) at Visit 6. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 6 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as [Baseline data]-[Visit 6 data].
Baseline (day 0) and Visit 6 (day 113±7).
MD Part - Change From Baseline of Best Corrected Visual Acuity (BCVA) at Visit 7
Time Frame: Baseline (day 0) and Visit 7 (day 155±7).
Change from baseline of best corrected visual acuity (BCVA) at Visit 7. BCVA was measured using the early treatment diabetic retinopathy study (ETDRS) visual acuity (VA) chart starting at a test distance of 7 meter. The BCVA score was the number of letters read correctly by the patient. Results calculated as [Baseline data]-[Visit 7 data].
Baseline (day 0) and Visit 7 (day 155±7).
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 3
Time Frame: Baseline (day 0) and Visit 3 (day 29±7).
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 3. Results calculated as [Baseline data]-[Visit 3 data].
Baseline (day 0) and Visit 3 (day 29±7).
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 4
Time Frame: Baseline (day 0) and Visit 4 (day 57±7)
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 4. Results calculated as [Baseline data]-[Visit 4 data].
Baseline (day 0) and Visit 4 (day 57±7)
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 5
Time Frame: Baseline (day 0) and Visit 5 (day 85±7).
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 5. Results calculated as [Baseline data]-[Visit 5 data].
Baseline (day 0) and Visit 5 (day 85±7).
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 6
Time Frame: Baseline (day 0) and Visit 6 (day 113±7).
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 6. Results calculated as [Baseline data]-[Visit 6 data].
Baseline (day 0) and Visit 6 (day 113±7).
MD Part - Change From Baseline of Central Retinal Thickness (CRT) at Visit 7
Time Frame: Baseline (day 0) and Visit 7 (day 155±7).
MD part - Change from baseline of central retinal thickness (CRT) in Spectral domain optical coherence tomography (SD-OCT) at Visit 7. Results calculated as [Baseline data]-[Visit 7 data].
Baseline (day 0) and Visit 7 (day 155±7).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 12, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1436-0001
  • 2019-004432-28 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions: 1. studies in products where Boehringer Ingelheim is not the license holder; 2. studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; 3. studies conducted in a single center or targeting rare diseases (because of limitations with anonymization).For more details refer to: https://www.mystudywindow.com/msw/datasharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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