HealthyPhase 1NCT04419493

A Study in Healthy Men to Compare 2 Different Formulations of Alteplase

A Phase 1 study testing Alteplase (from modified manufacturing process), Alteplase (from current manufacturing process) and Heparin-Natrium-5000-ratiopharm (unfractionated heparin) in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

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

Official record

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Trial summary

To establish the bioequivalence of alteplase derived from two different manufacturing processes. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Alteplase (from modified manufacturing process), Alteplase (from current manufacturing process) and Heparin-Natrium-5000-ratiopharm (unfractionated heparin)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteGermany
Study dates: 23 Jun 2020to 21 Jun 2021
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 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 45 years (inclusive)
Body mass index (weight divided by height squared) (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
Body weight of 65 - 100 kg (inclusive) at screening
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Who cannot join

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, e.g. thrombotic predisposition according to thrombophilic testing
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

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History of relevant orthostatic hypotension, fainting spells, or blackouts
Chronic or relevant acute infections
History of relevant allergy or hypersensitivity
During COVID-19 pandemic: laboratory test indicative of an ongoing SARS-CoV-2 infection Further exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

Germany1 site

Humanpharmakologisches Zentrum Biberach
Biberach, 88397

Other trials in Germany

About this study

Official title: Bioequivalence of Alteplase Derived From Two Different Manufacturing Processes Following Intravenous Administration in Healthy Male Volunteers

To establish the bioequivalence of alteplase derived from two different manufacturing processes.

Conditions: Healthy
Being tested: Alteplase (from modified manufacturing process), Alteplase (from current manufacturing process), Heparin-Natrium-5000-ratiopharm (unfractionated heparin)

What participants receive

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

Alteplase (from modified manufacturing process)Drug
Alteplase, TPA-05
Alteplase (from current manufacturing process)Drug
Alteplase, TPA-02
Heparin-Natrium-5000-ratiopharm (unfractionated heparin)Drug
Heparin-Natrium-5000-ratiopharm (unfractionated heparin)

Study groups in NCT04419493
Study group	Role	What they receive
Part B: Alteplase, TPA-02 then Alteplase, TPA-05	Experimental	Not described Receives: Drug: Alteplase (from modified manufacturing process); Drug: Heparin-Natrium-5000-ratiopharm (unfractionated heparin)
Part B: Alteplase, TPA-05 then Alteplase, TPA-02	Active comparator	Not described Receives: Drug: Alteplase (from current manufacturing process); Drug: Heparin-Natrium-5000-ratiopharm (unfractionated heparin)
Part A: Alteplase, TPA-05 then Alteplase, TPA-02	Experimental	Open-label Receives: Drug: Alteplase (from modified manufacturing process); Drug: Heparin-Natrium-5000-ratiopharm (unfractionated heparin)
Part A: Alteplase, TPA-02 then Alteplase, TPA-05	Active comparator	Not described Receives: Drug: Alteplase (from current manufacturing process); Drug: Heparin-Natrium-5000-ratiopharm (unfractionated heparin)

What is being measured

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

Part A: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz)
The area under the concentration-time curve of alteplase in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.
Measured: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz)
The area under the concentration-time curve of Alteplase in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.
Measured: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
Part A: Maximum Measured Concentration of Alteplase in Plasma (Cmax)
Maximum measured concentration of alteplase in plasma is reported.
Measured: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
Part B: Maximum Measured Concentration of Alteplase in Plasma (Cmax)
Maximum measured concentration of Alteplase in plasma (Cmax) is reported.
Measured: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.

Secondary outcomes (2)

Part A: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of alteplase in plasma over interval from 0 extrapolated to infinity is reported.
Measured: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Interval From 0 Extrapolated to Infinity (AUC0-∞)
Area under the concentration-time curve of alteplase in plasma over the interval from 0 extrapolated to infinity is reported.
Measured: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.

Timeline

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

23 Jun 202021 Jun 2021

First posted5 Jun 2020
Study start23 Jun 2020
Primary completion21 Jun 2021
Study completion21 Jun 2021

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 (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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
Model description: Part A: Open label Part B: Adaptive two-stage group-sequential design
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04419493
Sponsor's protocol ID: 0135-0340
Other IDs: 2019-004932-40, 2019
Status last verified: Apr 2023
First submitted: 4 Jun 2020
Last updated: 26 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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

Publications

Glund S, Hoefler J, Lang B, Cafiero S, Panova-Noeva M, Place C, Wolff M. Bioequivalence of Intravenous Alteplase from Two Different Manufacturing Processes in Healthy Male Volunteers: Results from a Two-Stage, Adaptive-Design Study. Clin Pharmacokinet. 2023 Jul;62(7):1023-1030. doi: 10.1007/s40262-023-01253-3. Epub 2023 May 30.
PubMed 37248330

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 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Bioequivalence of Alteplase Derived From Two Different Manufacturing Processes Following Intravenous Administration in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT04419493
Acronym / sponsor ID: 0135-0340
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 23 Jun 2020 (actual)
Primary completion: 21 Jun 2021 (actual)
Study completion: 21 Jun 2021 (actual)
First posted: 5 Jun 2020 (actual)
Results: Posted 26 Apr 2023

Clinical summary

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

To establish the bioequivalence of alteplase derived from two different manufacturing processes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4
Model description: Part A: Open label Part B: Adaptive two-stage group-sequential design

Arm	Type	Receives
Part B: Alteplase, TPA-02 then Alteplase, TPA-05	Experimental	Drug: Alteplase (from modified manufacturing process), Drug: Heparin-Natrium-5000-ratiopharm (unfractionated heparin)
Part B: Alteplase, TPA-05 then Alteplase, TPA-02	Active comparator	Drug: Alteplase (from current manufacturing process), Drug: Heparin-Natrium-5000-ratiopharm (unfractionated heparin)
Part A: Alteplase, TPA-05 then Alteplase, TPA-02	Experimental	Drug: Alteplase (from modified manufacturing process), Drug: Heparin-Natrium-5000-ratiopharm (unfractionated heparin)Open-label
Part A: Alteplase, TPA-02 then Alteplase, TPA-05	Active comparator	Drug: Alteplase (from current manufacturing process), Drug: Heparin-Natrium-5000-ratiopharm (unfractionated heparin)

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
Age of 18 to 45 years (inclusive)
Body mass index (weight divided by height squared) (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
Body weight of 65 - 100 kg (inclusive) at screening
Signed and dated written informed consent prior to admission to the study, in accordance with Good Clinical Practice (GCP) and local legislation

Key exclusion criteria (10 listed)

Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, e.g. thrombotic predisposition according to thrombophilic testing
Any evidence of a concomitant disease assessed as clinically relevant by the investigator
Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders

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
Alteplase (from modified manufacturing process)Alteplase, TPA-05	Drug	Part A: Alteplase, TPA-05 then Alteplase, TPA-02, Part B: Alteplase, TPA-02 then Alteplase, TPA-05
Alteplase (from current manufacturing process)Alteplase, TPA-02	Drug	Part A: Alteplase, TPA-02 then Alteplase, TPA-05, Part B: Alteplase, TPA-05 then Alteplase, TPA-02
Heparin-Natrium-5000-ratiopharm (unfractionated heparin)Heparin-Natrium-5000-ratiopharm (unfractionated heparin)	Drug	Part A: Alteplase, TPA-02 then Alteplase, TPA-05, Part A: Alteplase, TPA-05 then Alteplase, TPA-02, Part B: Alteplase, TPA-02 then Alteplase, TPA-05, Part B: Alteplase, TPA-05 then Alteplase, TPA-02

Primary outcome

Part A: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
The area under the concentration-time curve of alteplase in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.
Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz)
Time frame: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
The area under the concentration-time curve of Alteplase in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) is reported.
Part A: Maximum Measured Concentration of Alteplase in Plasma (Cmax)
Time frame: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
Maximum measured concentration of alteplase in plasma is reported.
Part B: Maximum Measured Concentration of Alteplase in Plasma (Cmax)
Time frame: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
Maximum measured concentration of Alteplase in plasma (Cmax) is reported.

2 secondary outcomes

Part A: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.
Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Interval From 0 Extrapolated to Infinity (AUC0-∞)
Time frame: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.

Results and safety

Results posted to the registry on 26 Apr 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Alteplase, TPA-02 Then Alteplase, TPA-05	6	6
Part A: Alteplase, TPA-05 Then Alteplase, TPA-02	6	6
Part B: Alteplase, TPA-02 Then Alteplase, TPA-05	9	9
Part B: Alteplase, TPA-05 Then Alteplase, TPA-02	9	9

Primary outcome: Part A: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz)

Population analysed: Pharmacokinetic parameter analysis set - part A (PKS-A): Includes all subjects in the treated set - part A (TS-A) who provide at least one PK endpoint that was defined as primary or secondary and was not excluded due to a protocol violation to the evaluation of PK or due to PK non-evaluability. PK data for Part A were not used for the final assessment of bioequivalence according to protocol amendment after obtaining unreliable PK results.

Primary outcome: Part B: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz)

Time frame: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.. Geometric least squares mean (Standard Error). Unit: hour * nanogram / milliliter (h*ng/mL)

Measure	Part B: Alteplase, TPA -02 n = 16	Part B: Alteplase, TPA-05 n = 16
Value	369.21 (NA)	377.35 (NA)

Part B: Alteplase, TPA -02 vs Part B: Alteplase, TPA-05: Geometric Least Squares Mean ratio (%): 102.20 (92.83% CI 94.87 to 110.10)

Population analysed: Pharmacokinetic parameter analysis set - part B(PKS-B): This set includes all subjects in the treated set - part B (TS-B) who provide at least one Pharmacokinetic (PK) endpoint that was defined as primary or secondary and was not excluded due to a protocol violation relevant to the evaluation of PK or due to PK non-evaluability.

Primary outcome: Part A: Maximum Measured Concentration of Alteplase in Plasma (Cmax)

Primary outcome: Part B: Maximum Measured Concentration of Alteplase in Plasma (Cmax)

Measure	Part B: Alteplase, TPA -02 n = 16	Part B: Alteplase, TPA-05 n = 16
Value	738.35 (NA)	781.24 (NA)

Part B: Alteplase, TPA -02 vs Part B: Alteplase, TPA-05: Geometric Least Squares Mean ratio (%): 105.81 (92.83% CI 99.18 to 112.88)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 22 days after the last administration of alteplase.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Alteplase, TPA-02	0 of 10 (0%)	1 of 10 (10%)	0 of 10
Part B: Alteplase, TPA-02	0 of 18 (0%)	7 of 18 (38.9%)	0 of 18
Part A: Alteplase, TPA-05	0 of 11 (0%)	4 of 11 (36.4%)	0 of 11
Part B: Alteplase, TPA-05	0 of 17 (0%)	6 of 17 (35.3%)	0 of 17

Limitations and caveats (from the sponsor): For study Part A three subjects underwent only one treatment period, thereafter the trial was put on-hold. Trial Part B was performed as planned. There were no important protocol deviations (IPDs). Each entered subject met all of the inclusion criteria and none of the exclusion criteria.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37248330Glund S, Hoefler J, Lang B, Cafiero S, Panova-Noeva M, Place C, Wolff M. Bioequivalence of Intravenous Alteplase from Two Different Manufacturing Processes in Healthy Male Volunteers: Results from a Two-Stage, Adaptive-Design Study. Clin Pharmacokinet. 2023 Jul;62(7):1023-1030. doi: 10.1007/s40262-023-01253-3. Epub 2023 May 30.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. 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

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 10 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 26 Apr 2023. 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 Germany. 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 26 Apr 2023). 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?

Part A: Area Under the Concentration-time Curve of Alteplase in Plasma Over the Time Interval From 0 up to the Last Quantifiable Data Point (AUC0-tz) (time frame: Within 3 hours (h) before and 5 minutes (min), 10min, 15min, 20min, 25min, 30min, 32min, 34min, 36min, 40min, 45min, 50min, 1h, 1.33h, 1.67h, 2h, 3h, 4h and 6h after start of alteplase infusion.). The study lists 4 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 NCT04419493, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.