An observational study in Thromboembolism, sponsored by Boehringer Ingelheim. Completed at 3 sites in India. Per ClinicalTrials.gov, last updated 2023-08-25.
Sponsored by Boehringer Ingelheim · Observational
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Among 12 studies in Thromboembolism by Boehringer Ingelheim — none open to participants now, none under way, none of them phase 3. Thromboembolism · Boehringer Ingelheim.
Among the 12 studies in Thromboembolism by Boehringer Ingelheim, this one is the only one that started in 2018, is one of 4 observational ones, and was the 12th registered.
288 studies on the registry are indexed under Thromboembolism; 42 are open to participants now.
Browse Thromboembolism studies →None of the 12 studies in Thromboembolism by Boehringer Ingelheim is open now. The open studies under Thromboembolism, anywhere →
Of the 32 Thromboembolism studies recruiting now, 23 (72%) set no upper age limit and 4 (13%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2018.
This study's enrollment of 5 is below the median of 440 across 121 observational studies indexed under Thromboembolism.
Median enrollment 2,577 across the 8 interventional studies, 239 across the 4 observational. Of the 12 that completed or were terminated, 12 (100%) have results posted.
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Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 61 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 123 (73%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Thromboembolism by Boehringer Ingelheim, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This program will be initiated after the commercial availability of PraxbindTM in India. It will include patients administered with PraxbindTM into the surveillance program after commercial availability in 2 years at selected centres approved by the regulatory authority.
All patients, who receive PraxbindTM prescribed as per the approved label
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
-Participation in a PraxbindTM clinical trial
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: PraxbindTM
Drug
Also known as: PRAXBIND, Praxbind, Prizbind
Number of Participants With Suspected Adverse Drug Reactions (ADRs) and Fatal Adverse Events (AEs)
Number of participants with suspected adverse drug reactions (ADRs) and fatal adverse events (AEs) occurring within 7 days after Praxbind® administration.
Time frame: Up to 7 days following treatment.
Percentage of Patients Who Received Praxbind® Either for Emergency Surgery/Urgent Procedures or for Life-threatening or Uncontrolled Bleeding
Percentage of patients who received Praxbind® either for emergency surgery/urgent procedures or for life-threatening or uncontrolled bleeding.
Time frame: Data collected from patients who had been treated with Praxbind® within 2 years of the commercial availability of Praxbind®.
This was a multicenter, non-interventional, drug administration surveillance program.
| Milestone | Praxbind® |
|---|---|
| Started | 5 |
| Completed | 5 |
| Not completed | 0 |
Number of participants with suspected adverse drug reactions (ADRs) and fatal adverse events (AEs) occurring within 7 days after Praxbind® administration.
| Participants | Praxbind® |
|---|---|
| Number of participants with ADRs | 0 |
| Number of participants with AEs | 0 |
Percentage of patients who received Praxbind® either for emergency surgery/urgent procedures or for life-threatening or uncontrolled bleeding.
| Percentage of participants | Praxbind® |
|---|---|
| For emergency surgery/urgent procedures | 20 |
| In life-threatening or uncontrolled bleeding | 80 |
Collected over Up to 7 days following treatment.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Praxbind® | 0/5 (0%) | 0/5 (0%) | 1/5 (20%) |
| Event | Praxbind® |
|---|---|
| Abdominal painGastrointestinal disorders | 1/5 |
| ProctalgiaGastrointestinal disorders | 1/5 |
Treated Set: Includes patients, who signed the ICF (Informed consent form), met the eligibility criteria and received Praxbind®.
| Age, Continuous(years) | Praxbind® |
|---|---|
| Mean | 64.8 ± 8.44 |
| Sex: Female, Male(Participants) | Praxbind® |
|---|---|
| Female | 2 |
| Male | 3 |
| Race and Ethnicity Not Collected(Participants) | Praxbind® |
|---|
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — 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). Requestors can use the following link http://trials.boehringer-ingelheim.com/ to: find information in order to request access to clinical study data, for listed studies. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.
Ran from Dec 2018 to primary completion in Jan 2020, 12 months.
Results were first posted in Feb 2021, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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