Antithrombin III DeficiencyPhase 2/3NCT00319228
Safety, Pharmacokinetics and Efficacy of an ATIII Concentrate
A Phase 2/3 study testing Plasma-derived AT-III concentrate in people with Antithrombin III Deficiency, run by Instituto Grifols, S.A..
Trial summary
To assess the safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in the treatment of subjects with congenital AT-III deficiency. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Antithrombin III Deficiency
- What is being tested?
- Plasma-derived AT-III concentrate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2008to 16 Dec 2011
- Phase
- Phase 2/3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Congenital ATIII deficiency documented by determination of plasma levels of ATIII off all therapies. Specifically, the baseline levels of ATIII activity should have been equal to or less than 60%.
- Age >12 years with a body weight of no less than 30 kg.
- Subject must not have participated in another investigational study for at least 30 days.
- For Segment II, enrollment required a pregnancy/delivery or a surgical procedure (it should have been a major surgery although data from a minor surgery would also have been collected).
- For Segment II only, documented personal history of major thromboembolic or thrombotic event.
- HIV, HBV, HCV, HAV and PARVO B19 status known prior to entry.
Show all 10Show fewer
- The subject must have been willing to comply with all aspects of the protocol, including blood sampling, for the duration of the study.
- The subject signed an informed consent form (if at least 18 years old), or the subject's parent or legal guardian signed the informed consent form. Subjects below the age of 18 years were asked to sign an assent form. All consent and assent forms must have been approved in advance by the Institutional Review Board of the investigator's institution.
- Patients with heparin-associated thrombocytopenia who required anticoagulation with non-heparin containing drugs were eligible if they could be safely transitioned during the washout period for the Segment I PK study.
- If pregnant, a woman must have been Parvo B19 IgG antibody positive.
Who cannot join
- Acquired deficiency of ATIII.
- Subject who received concomitant treatment for thrombophilic disorders other than ATIII deficiency.
- History of anaphylactic reaction(s) to blood or blood components.
- Allergies to excipients.
- Liver function tests >/= 2.5 X ULN
- Serum creatinine >1.2 X ULN.
Show all 10Show fewer
- Urine >/= 2+ protein with urine dipstick test.
- The subject was known to have abused alcohol or illicit drugs within the past 12 months.
- The subject was unlikely to adhere to the protocol requirements of the study or was likely to be uncooperative or unable to provide a storage serum sample at the screening visit.
- Patients on heparin-treatment who, for clinical reasons, could not safely be discontinued from heparin therapy during the PK segment.
About this study
Official title: A Phase II/III Pivotal Trial Evaluating the Safety, Pharmacokinetic Properties and Efficacy of a Plasma-Derived Anti-thrombin III Concentrate With Administration in Surgery, Pregnancy and Thromboembolic or Thrombotic Events
To assess the safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in the treatment of subjects with congenital AT-III deficiency.
Read the detailed description
This study was a prospective, unblinded, non-randomized, open-label, multi-center Phase II/III study with 2 segments, i.e. a PK evaluation (Segment I), and an assessment of prophylaxis in surgical interventions and pregnancy/delivery, (Segment II). During the PK segment (Segment I), the subjects were to be remained on their current anticoagulation therapy except for subjects on heparin therapy where a wash-out period of at least 5 half-lives was to be required. In total, 15 subjects with congenital ATIII Deficiency were to be enrolled for the PK assessment (Segment I).
For Segment II, fifteen episodes were to be treated. Recruitment of individual subjects with high risk for venous thrombosis for Segment II of this study was necessary because of the rarity of Antithrombin deficiency in the population.
- Conditions
- Antithrombin III Deficiency
- Being tested
- Plasma-derived AT-III concentrate
- Keywords
- AT-III deficiency, AT-III concentrate, Bleeding disorders, Blood disorders
- Medical subject headings
- Antithrombin III Deficiency, Hemostatic Disorders, Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma-derived AT-III concentrateDrug
Segment I: A single dose IV infusion of 50 IU/kg of ATIII-DAF/DI was administered to each patient.
Segment II: A single dose or multiple doses depending on the subject's ATIII plasma levels and patient's specific treatment plan.
| Study group | Role | What they receive |
|---|---|---|
| Antithrombin III | Experimental | Not described Receives: Drug: Plasma-derived AT-III concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the Pharmacokinetic Profile (T1/2) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study.
Assess the pharmacokinetic profile of parameters T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL] of AT-III in congenital AT-III deficient patients.
AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Chromogenic assay data reported in % was used for pharmacokinetic parameter estimation.
Pharmacokinetic parameters were estimated using noncompartmental analysis of antithrombin concentration-time data collected from Day 1 through Day 16. Reported values are derived estimates based on the concentration-time profile and may include extrapolation beyond the last measurable concentration, where applicable.
Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Measured: 30 minutes before the first infusion on Day 1 through Day 16 (pharmacokinetic parameters estimated using concentration-time data collected during this period)
Assess the Pharmacokinetic Profile (AUC) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study.
Assess the pharmacokinetic profile of parameters T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL] of AT-III in congenital AT-III deficient patients.
AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Chromogenic assay data reported in % was used for pharmacokinetic parameter estimation.
Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Measured: 30 minutes before the first infusion on Day 1 to Day 16.
Assess the Pharmacokinetic Profile (MRT) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study.
Assess the pharmacokinetic profile of parameters T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL] of AT-III in congenital AT-III deficient patients.
AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Chromogenic assay data reported in % was used for pharmacokinetic parameter estimation.
Pharmacokinetic parameters were estimated using noncompartmental analysis of antithrombin concentration-time data collected from Day 1 through Day 16. Reported values are derived estimates based on the concentration-time profile and may include extrapolation beyond the last measurable concentration, where applicable.
Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Measured: 30 minutes before the first infusion on Day 1 through Day 16 (pharmacokinetic parameters estimated using concentration-time data collected during this period)
Assess the Pharmacokinetic Profile (Vdss) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study.
Assess the pharmacokinetic profile of parameters T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL] of AT-III in congenital AT-III deficient patients.
AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Chromogenic assay data reported in % was used for pharmacokinetic parameter estimation.
Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Measured: 30 minutes before the first infusion on Day 1 to Day 16.
Assess the Pharmacokinetic Profile (CL) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study.
Assess the pharmacokinetic profile of parameters T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL] of AT-III in congenital AT-III deficient patients.
AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Chromogenic assay data reported in % was used for pharmacokinetic parameter estimation.
Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Measured: 30 minutes before the first infusion on Day 1 to Day 16.
Assess the Pharmacokinetic Profile (T1/2) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study.
Assess the pharmacokinetic profile of T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL]) of AT-III in congenital AT-III deficient patients.
AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT.
Pharmacokinetic parameters were estimated using noncompartmental analysis of antithrombin concentration-time data collected from Day 1 through Day 16. Reported values are derived estimates based on the concentration-time profile and may include extrapolation beyond the last measurable concentration, where applicable.
Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Measured: 30 minutes before the first infusion on Day 1 through Day 16 (pharmacokinetic parameters estimated using concentration-time data collected during this period)
Assess the Pharmacokinetic Profile (AUC) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study.
Assess the pharmacokinetic profile of T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL]) of AT-III in congenital AT-III deficient patients.
AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT.
Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Measured: 30 minutes before the first infusion on Day 1 to Day 16.
Assess the Pharmacokinetic Profile (MRT) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study.
Assess the pharmacokinetic profile of T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL]) of AT-III in congenital AT-III deficient patients.
AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT.
Pharmacokinetic parameters were estimated using noncompartmental analysis of antithrombin concentration-time data collected from Day 1 through Day 16. Reported values are derived estimates based on the concentration-time profile and may include extrapolation beyond the last measurable concentration, where applicable.
Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Measured: 30 minutes before the first infusion on Day 1 through Day 16 (pharmacokinetic parameters estimated using concentration-time data collected during this period)
Assess the Pharmacokinetic Profile (Vdss) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study.
Assess the pharmacokinetic profile of T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL]) of AT-III in congenital AT-III deficient patients.
AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT.
Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Measured: 30 minutes before the first infusion on Day 1 to Day 16.
Assess the Pharmacokinetic Profile (CL) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study.
Assess the pharmacokinetic profile of T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL]) of AT-III in congenital AT-III deficient patients.
AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT.
Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Measured: 30 minutes before the first infusion on Day 1 to Day 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study start15 Apr 2008
- Primary completionDec 2011
- Study completion16 Dec 2011
Why it stopped: Due to recruitment challenges during the trial, this study was terminated early by the Sponsor.
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.
- Other trials for Antithrombin III 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 2/3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Grifols, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319228
- Sponsor's protocol ID
- IG-401
- Status last verified
- Sep 2026
- First submitted
- 26 Apr 2006
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Pivotal Trial Evaluating the Safety, Pharmacokinetic Properties and Efficacy of a Plasma-Derived Anti-thrombin III Concentrate With Administration in Surgery, Pregnancy and Thromboembolic or Thrombotic Events
- ClinicalTrials.gov ID
- NCT00319228
- Acronym / sponsor ID
- IG-401
- Conditions
- Antithrombin III Deficiency
- Keywords
- AT-III deficiency, AT-III concentrate, Bleeding disorders, Blood disorders
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to recruitment challenges during the trial, this study was terminated early by the Sponsor.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Instituto Grifols, S.A.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2008 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- 16 Dec 2011 (actual)
- First posted
- 27 Apr 2006 (estimated)
- Results
- Posted 7 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in the treatment of subjects with congenital AT-III deficiency.
Detailed description
This study was a prospective, unblinded, non-randomized, open-label, multi-center Phase II/III study with 2 segments, i.e. a PK evaluation (Segment I), and an assessment of prophylaxis in surgical interventions and pregnancy/delivery, (Segment II). During the PK segment (Segment I), the subjects were to be remained on their current anticoagulation therapy except for subjects on heparin therapy where a wash-out period of at least 5 half-lives was to be required. In total, 15 subjects with congenital ATIII Deficiency were to be enrolled for the PK assessment (Segment I).
For Segment II, fifteen episodes were to be treated. Recruitment of individual subjects with high risk for venous thrombosis for Segment II of this study was necessary because of the rarity of Antithrombin deficiency in the population.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antithrombin III | Experimental | Drug: Plasma-derived AT-III concentrate |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Congenital ATIII deficiency documented by determination of plasma levels of ATIII off all therapies. Specifically, the baseline levels of ATIII activity should have been equal to or less than 60%.
- Age >12 years with a body weight of no less than 30 kg.
- Subject must not have participated in another investigational study for at least 30 days.
- For Segment II, enrollment required a pregnancy/delivery or a surgical procedure (it should have been a major surgery although data from a minor surgery would also have been collected).
- For Segment II only, documented personal history of major thromboembolic or thrombotic event.
Key exclusion criteria (10 listed)
- Acquired deficiency of ATIII.
- Subject who received concomitant treatment for thrombophilic disorders other than ATIII deficiency.
- History of anaphylactic reaction(s) to blood or blood components.
- Allergies to excipients.
- Liver function tests >/= 2.5 X ULN
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 |
|---|---|---|
| Plasma-derived AT-III concentrateSegment I: A single dose IV infusion of 50 IU/kg of ATIII-DAF/DI was administered to each patient. Segment II: A single dose or multiple doses depending on the subject's ATIII plasma levels and patient's specific treatment plan. | Drug | Antithrombin III |
Primary outcome
Assess the Pharmacokinetic Profile (T1/2) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study.
Time frame: 30 minutes before the first infusion on Day 1 through Day 16 (pharmacokinetic parameters estimated using concentration-time data collected during this period)
Assess the pharmacokinetic profile of parameters T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL] of AT-III in congenital AT-III deficient patients. AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Chromogenic assay data reported in % was used for pharmacokinetic parameter estimation. Pharmacokinetic parameters were estimated using noncompartmental analysis of antithrombin concentration-time data collected from Day 1 through Day 16. Reported values are derived estimates based on the concentration-time profile and may include extrapolation beyond the last measurable concentration, where applicable. Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Assess the Pharmacokinetic Profile (AUC) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study.
Time frame: 30 minutes before the first infusion on Day 1 to Day 16.
Assess the pharmacokinetic profile of parameters T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL] of AT-III in congenital AT-III deficient patients. AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Chromogenic assay data reported in % was used for pharmacokinetic parameter estimation. Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Assess the Pharmacokinetic Profile (MRT) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study.
Time frame: 30 minutes before the first infusion on Day 1 through Day 16 (pharmacokinetic parameters estimated using concentration-time data collected during this period)
Assess the pharmacokinetic profile of parameters T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL] of AT-III in congenital AT-III deficient patients. AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Chromogenic assay data reported in % was used for pharmacokinetic parameter estimation. Pharmacokinetic parameters were estimated using noncompartmental analysis of antithrombin concentration-time data collected from Day 1 through Day 16. Reported values are derived estimates based on the concentration-time profile and may include extrapolation beyond the last measurable concentration, where applicable. Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Assess the Pharmacokinetic Profile (Vdss) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study.
Time frame: 30 minutes before the first infusion on Day 1 to Day 16.
Assess the pharmacokinetic profile of parameters T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL] of AT-III in congenital AT-III deficient patients. AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Chromogenic assay data reported in % was used for pharmacokinetic parameter estimation. Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Assess the Pharmacokinetic Profile (CL) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study.
Time frame: 30 minutes before the first infusion on Day 1 to Day 16.
Assess the pharmacokinetic profile of parameters T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL] of AT-III in congenital AT-III deficient patients. AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Chromogenic assay data reported in % was used for pharmacokinetic parameter estimation. Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Assess the Pharmacokinetic Profile (T1/2) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study.
Time frame: 30 minutes before the first infusion on Day 1 through Day 16 (pharmacokinetic parameters estimated using concentration-time data collected during this period)
Assess the pharmacokinetic profile of T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL]) of AT-III in congenital AT-III deficient patients. AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Pharmacokinetic parameters were estimated using noncompartmental analysis of antithrombin concentration-time data collected from Day 1 through Day 16. Reported values are derived estimates based on the concentration-time profile and may include extrapolation beyond the last measurable concentration, where applicable. Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Assess the Pharmacokinetic Profile (AUC) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study.
Time frame: 30 minutes before the first infusion on Day 1 to Day 16.
Assess the pharmacokinetic profile of T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL]) of AT-III in congenital AT-III deficient patients. AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Assess the Pharmacokinetic Profile (MRT) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study.
Time frame: 30 minutes before the first infusion on Day 1 through Day 16 (pharmacokinetic parameters estimated using concentration-time data collected during this period)
Assess the pharmacokinetic profile of T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL]) of AT-III in congenital AT-III deficient patients. AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Pharmacokinetic parameters were estimated using noncompartmental analysis of antithrombin concentration-time data collected from Day 1 through Day 16. Reported values are derived estimates based on the concentration-time profile and may include extrapolation beyond the last measurable concentration, where applicable. Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Assess the Pharmacokinetic Profile (Vdss) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study.
Time frame: 30 minutes before the first infusion on Day 1 to Day 16.
Assess the pharmacokinetic profile of T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL]) of AT-III in congenital AT-III deficient patients. AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Assess the Pharmacokinetic Profile (CL) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study.
Time frame: 30 minutes before the first infusion on Day 1 to Day 16.
Assess the pharmacokinetic profile of T1/2, area under the curve [AUC], mean residence time [MRT], volume of distribution at steady-state [Vdss], and clearance of substrate [CL]) of AT-III in congenital AT-III deficient patients. AT PK parameters were determined by two methods: chromogenic to determine the activity of AT, and radial immunodiffusion to determine the antigen of AT. Due to the small number of subjects in Segment I, no data integration across the 2 subjects nor statistical analysis of these PK parameters were performed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Plasma-derived AT-III concentrate in people with Antithrombin III Deficiency, run by Instituto Grifols, S.A..
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 10 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: stopped early, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 7 Oct 2026). 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?
Assess the Pharmacokinetic Profile (T1/2) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study. (time frame: 30 minutes before the first infusion on Day 1 through Day 16 (pharmacokinetic parameters estimated using concentration-time data collected during this period)). The study lists 10 primary outcomes in all. 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 7 Oct 2026.