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Trial record 8 of 13 for:    Idarucizumab OR praxbind

PraxbindTM India PMS Program

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ClinicalTrials.gov Identifier: NCT03359889
Recruitment Status : Recruiting
First Posted : December 2, 2017
Last Update Posted : June 11, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease Intervention/treatment
Thromboembolism Drug: PraxbindTM

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Post Marketing Surveillance Program of Praxbind Use in India.
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : February 2, 2020
Estimated Study Completion Date : February 9, 2020

Group/Cohort Intervention/treatment
patients administered with PraxbindTM Drug: PraxbindTM
Drug
Other Name: PRAXBIND, Praxbind, Prizbind




Primary Outcome Measures :
  1. Any suspected Adverse Drug Reactions [ Time Frame: within 7 days ]
    with special focus on hypersensitivity and thrombotic event

  2. fatal Adverse events [ Time Frame: within 7 days ]
    with special focus on hypersensitivity and thrombotic event


Secondary Outcome Measures :
  1. patients who either received PraxbindTM for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding [ Time Frame: at the end of 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients, who receive PraxbindTM prescribed as per the approved label
Criteria

Inclusion Criteria:

- Patients treated with Pradaxa (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran: For emergency surgery/urgent procedures (or) In life-threatening or uncontrolled bleeding

- Written informed consent in accordance with International Conference on Harmonization Good Clinical Practice (GCP) guidelines and local legislation and/or regulations

Exclusion Criteria:

-Participation in a PraxbindTM clinical trial


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03359889


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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India
Mazumdar Shaw Medical centre Recruiting
Bangalore, India, 560099
Contact: Vikram Huded    +91-9900002101    drvikramhuded@gmail.com   
Batra Hospital and Medical Research Centre Recruiting
New Delhi, India, 110 062
Contact: Upendra Kaul    +91-1147135138    kaul.upendra@gmail.com   
Sponsors and Collaborators
Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03359889     History of Changes
Other Study ID Numbers: 1321-0023
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: June 11, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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). Requestors can use the following link http://trials.boehringer-ingelheim.com/ to:

  1. find information in order to request access to clinical study data, for listed studies.
  2. request access to clinical study documents that meet criteria, and upon a signed 'Document Sharing Agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases