Prothrombin Complex Factor DeficiencyPhase 4NCT01159210
Efficacy and Safety of Prothromplex Total (Prothrombin Complex Concentrate) in Oral Anticoagulant Reversal
A Phase 4 study testing Prothrombin complex concentrate (coagulation factors IX, II, VII and X in combination) in people with Prothrombin Complex Factor Deficiency, run by Baxalta now part of Shire at 6 sites in 2 countries.
Trial summary
The purpose of the study is to assess the efficacy and safety of Prothromplex Total as a treatment for the immediate reversal of oral anticoagulant therapy with vitamin K antagonists in patients with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Prothrombin Complex Factor Deficiency
- What is being tested?
- Prothrombin complex concentrate (coagulation factors IX, II, VII and X in combination)
- Type of treatment
- Injection or infusion
- How many people
- 61 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 9 Jul 2010to 7 Apr 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject is at least 16 years or older at enrolment with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X), due to oral anticoagulation with vitamin K antagonists (e.g. coumarin, warfarin), requiring reversal of oral anticoagulation for urgent surgery, or invasive procedure or acute bleeding episode
- Subject or parent/legally authorised representative has provided written informed consent
- Subject has INR >= 2,0 at screening
- Subject is willing and able to comply with the requirements of the protocol
Who cannot join
- Subject has laboratory and/or clinical symptoms which are clearly indicative of overt disseminated intravascular coagulation (DIC)
- Subject has been treated with whole blood, fresh frozen plasma (FFP), or platelets within 6 hours prior to study enrolment
- Subject has a hypersensitivity to prothrombin complex concentrate (PCC) constituents (including heparin-induced thrombocytopenia)
- Subject has blood loss of >= 5 units of blood
- Subject has hereditary thrombophilia or bleeding disorder
- Subject has a life expectancy of < 3 months
Show all 11Show fewer
- Subject has been on oral anticoagulant treatment for a period of < 4 weeks for the treatment of a thrombotic event such as deep vein thrombosis or pulmonary embolism
- Subject has an acute ischemic cardiovascular disorder
- Subject has or is suspected to have sepsis
- Subject with acute or chronic liver failure (hepatic cirrhosis Child-PUGH score C)
- Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrolment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Austria3 sites
Landeskrankenhaus Feldkirch
Feldkirch, 6807
Universitätsklinik für Innere Medizin I (University Hospital for Internal Medicine I), Allgemeines Krankenhaus der Stadt Wien (General Hospital Vienna)
Vienna, 1090
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
Vienna, 1130
Hungary3 sites
DEOEC, University of Debrecen, Medical and Health Science Centre
Debrecen, 4032
Fejer Megyei Szent György Korhaz
Székesfehérvár, 8000
Veszprem Megyei Csolnoky Korhaz Nonprofit Zrt., Belgyógyászati Centrum, Haematológiai Részleg
Veszprém, 8200
About this study
Official title: An International, Multi-centre, Prospective, Open-Label, Non-Randomised, Uncontrolled Study to Assess the Efficacy and Safety of Prothromplex Total in Oral Anticoagulant Reversal in Patients With Acquired Deficiency of Prothrombin Complex Coagulation Factors (II, VII, IX, X)
The purpose of the study is to assess the efficacy and safety of Prothromplex Total as a treatment for the immediate reversal of oral anticoagulant therapy with vitamin K antagonists in patients with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X). Upon enrolment, subjects will receive Prothromplex Total for the treatment of acute bleeding due to oral anticoagulants or for the prevention of excessive bleeding during the interventional procedure (Day 1). Additional doses of Prothromplex Total may be administered at the discretion of the investigator. Efficacy and safety assessments will be performed during a period of 72 (± 4) hours after administration of the last dose of Prothromplex Total or until discharge from hospital, whichever occurs first.
- Conditions
- Prothrombin Complex Factor Deficiency
- Being tested
- Prothrombin complex concentrate (coagulation factors IX, II, VII and X in combination)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prothrombin complex concentrate (coagulation factors IX, II, VII and X in combination)Biological
Also called Prothromplex Total
Intravenous infusion; regimen is guided by the pre-treatment international normalised ratio (INR); dosage and duration of replacement therapy depend on the severity of the disorder, on the location and extent of bleeding and on the patient´s clinical condition.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who achieve normalisation of International normalised ratio (INR) to <= 1.3 within 30 (±5) minutes post administration of Prothromplex Total
Measured: within 35 minutes after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study start9 Jul 2010
- Primary completion7 Apr 2012
- Study completion7 Apr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prothrombin Complex Factor DeficiencyStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159210
- Sponsor's protocol ID
- 220901
- Other IDs
- 2010-019250-41
- Status last verified
- Apr 2021
- First submitted
- 8 Jul 2010
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Multi-centre, Prospective, Open-Label, Non-Randomised, Uncontrolled Study to Assess the Efficacy and Safety of Prothromplex Total in Oral Anticoagulant Reversal in Patients With Acquired Deficiency of Prothrombin Complex Coagulation Factors (II, VII, IX, X)
- ClinicalTrials.gov ID
- NCT01159210
- Acronym / sponsor ID
- 220901
- Conditions
- Prothrombin Complex Factor Deficiency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2010 (actual)
- Primary completion
- 7 Apr 2012 (actual)
- Study completion
- 7 Apr 2012 (actual)
- First posted
- 9 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess the efficacy and safety of Prothromplex Total as a treatment for the immediate reversal of oral anticoagulant therapy with vitamin K antagonists in patients with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X). Upon enrolment, subjects will receive Prothromplex Total for the treatment of acute bleeding due to oral anticoagulants or for the prevention of excessive bleeding during the interventional procedure (Day 1). Additional doses of Prothromplex Total may be administered at the discretion of the investigator. Efficacy and safety assessments will be performed during a period of 72 (± 4) hours after administration of the last dose of Prothromplex Total or until discharge from hospital, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is at least 16 years or older at enrolment with acquired deficiency of prothrombin complex coagulation factors (II, VII, IX, X), due to oral anticoagulation with vitamin K antagonists (e.g. coumarin, warfarin), requiring reversal of oral anticoagulation for urgent surgery, or invasive procedure or acute bleeding episode
- Subject or parent/legally authorised representative has provided written informed consent
- Subject has INR >= 2,0 at screening
- Subject is willing and able to comply with the requirements of the protocol
Key exclusion criteria (11 listed)
- Subject has laboratory and/or clinical symptoms which are clearly indicative of overt disseminated intravascular coagulation (DIC)
- Subject has been treated with whole blood, fresh frozen plasma (FFP), or platelets within 6 hours prior to study enrolment
- Subject has a hypersensitivity to prothrombin complex concentrate (PCC) constituents (including heparin-induced thrombocytopenia)
- Subject has blood loss of >= 5 units of blood
- Subject has hereditary thrombophilia or bleeding disorder
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 |
|---|---|---|
| Prothrombin complex concentrate (coagulation factors IX, II, VII and X in combination)Also: Prothromplex TotalIntravenous infusion; regimen is guided by the pre-treatment international normalised ratio (INR); dosage and duration of replacement therapy depend on the severity of the disorder, on the location and extent of bleeding and on the patient´s clinical condition. | Biological | – |
Primary outcome
Proportion of subjects who achieve normalisation of International normalised ratio (INR) to <= 1.3 within 30 (±5) minutes post administration of Prothromplex Total
Time frame: within 35 minutes after administration of study drug
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
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Complex Cardiovascular Surgery With Cardiopulmonary Bypass
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.
Study Director study director
Takeda
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prothrombin complex concentrate (coagulation factors IX, II, VII and X in combination) in people with Prothrombin Complex Factor Deficiency, run by Baxalta now part of Shire at 6 sites in 2 countries.
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 4 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 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria, Hungary. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects who achieve normalisation of International normalised ratio (INR) to <= 1.3 within 30 (±5) minutes post administration of Prothromplex Total (time frame: within 35 minutes after administration of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 May 2021.