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Safety, Pharmacokinetics and Efficacy of an ATIII Concentrate

StatusTerminated
PhasePhase 2/3
Started2008-04-15
View on ClinicalTrials.gov ↗

Amendment history

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
2026-09-15
Active, Not Recruiting→Terminated
Trial terminated: Due to recruitment challenges during the trial, this study was terminated early by the Sponsor.
Primary endpoint(s) modified4 to 10 entries
WasAssess the pharmacokinetic (PK) profile of AT-III in congenital AT-III deficient patients, The primary objectives of this clinical study are to:, To assess the clinical safety and tolerability of AT-III-DAF/DI., To measure the in vivo recovery and half-life of AT-III.
NowAssess the Pharmacokinetic Profile (AUC) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study., Assess the Pharmacokinetic Profile (AUC) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study., Assess the Pharmacokinetic Profile (CL) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study., Assess the Pharmacokinetic Profile (CL) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study., Assess the Pharmacokinetic Profile (MRT) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study., Assess the Pharmacokinetic Profile (MRT) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study., Assess the Pharmacokinetic Profile (T1/2) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study., 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 (Vdss) of Anbinex® Using Chromogenic Methods for Subjects Enrolled in Segment 1 of the Study., Assess the Pharmacokinetic Profile (Vdss) of Anbinex® Using Radial Immunodiffusion Methods for Subjects Enrolled in Segment 1 of the Study.
Final enrollment: 3 participants (planned 30)
Sponsor changed: Grifols Biologicals, LLC → Instituto Grifols, S.A.-1 characters
WasGrifols Biologicals, LLC
NowInstituto Grifols, S.A.
Primary completion confirmed: December 2011 (last estimated December 2028)
Results posted: 2026-10-07
Trial statusActive, Not Recruiting→Terminated
Primary completion dateestimated 2028-12→confirmed 2011-12
Completion dateestimated 2029-03→confirmed 2011-12-16
Start date2006-01→2008-04-15
Enrollment targetestimated 30→confirmed 3
Eligibility criteria+43 characters
Inclusion Criteria: * Congenital ATIII deficiency documented by determination of p [...] Specifically, the baseline levels of ATIII activity should behave been equal to or less than 60%. * Age \>12 years with a body weight of no less than 30 kg. Have* Subject must not have participated in another investigational study for at least 30 days. * For Segment II, enrollment requiresrequired a pregnancy/delivery or a surgical procedure (it should behave been a major surgery although data from a minor surgery willwould also behave been collected). Documented* For Segment II only, documented personal history [...] [...]
Secondary endpoints-227 characters
To assess clinical efficacy by preventing thromboembolic or thrombotic events (prophylaxis) in individuals with congenital AT-III deficiency who are undergoing surgical procedures or who are pregnant and undergoing parturition.
Study description+11 characters
This study will bewas a prospective, unblinded, non-randomized, open-label, multi [...] egment II). During the PK segment (Segment I), the subjects wouldwere remainto be remained on their current anticoagulation therapy except for subject [...] in therapy where a wash-out period of at least 5 half-lives wouldwas to be required. In total, 15 subjects with congenital ATIII Deficiency willwere to be enrolled for the PK assessment (Segment I). For Segment II, fifteen episodes willwere to be treated. Recruitment of individual subjects with high risk for venous thrombosis for Segment II of this study iswas necess [...]
2023-08-24
Study Status v17
Re-verified, no change to tracked fields
2022-05-05
Study Identification, Study Status, Study Description, Eligibility, Contacts/Locations v16
Eligibility criteria+5 characters
[...] ipated in another investigational study for at least 30 days. For Segment II, enrollment requires a pregnancy/delivery or [...] y positive. Exclusion Criteria: Acquired deficiency of ATIII. Receiving concomitant treatment for thrombophilic disorders other than ATIII deficiency. Inability or unwillingness to comply with the protocol requirements. 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. Urine >/= 2+ protein with urine dipstick test. The subject [...]
Study description+12 characters
[...] and pregnancy/delivery, (Segment II). During the PK segment (Segment I), the subjects would remain on their current anticoagulation [...] n heparin therapy where a wash-out period of at least 5 half-lives would be required. In total, 15 subjects with congenit [...]
Study title-2 characters
Safety, Pharmacokinetics and Efficacy of an AT-IIIATIII Concentrate.
2021-01-04
2 amendments v14-v15
2 re-verifications since 2019-04-09, no change to tracked fields
2018-03-08
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v13
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2018-12→2028-12
Completion date2019-03→2029-03
Study sites2→0
Show 11 earlier versions
2017-01-20
Study Status v12
Re-verified, no change to tracked fields
2014-02-17
Study Status v11
Primary completion date2017-12→2018-12
Completion date2018-03→2019-03
2013-03-18
Study Status, Contacts/Locations v10
Study sites3→2
2012-08-30
3 amendments v7-v9
3 re-verifications since 2011-09-06, no change to tracked fields
2011-02-16
Study Status, Contacts/Locations v6
Primary completion date2012-12→2017-12
Completion date2013-01→2018-03
Study sites5→3
2010-04-26
Study Status, Sponsor/Collaborators, Contacts/Locations v5
Re-verified, no change to tracked fields
2010-03-15
Study Identification, Study Status, Arms and Interventions, Contacts/Locations v4
Primary completion date2010-12→2012-12
Completion date2010-12→2013-01
Study arms0→1
2008-05-12
Study Status, Contacts/Locations v3
Study sites1→5
2008-02-04
Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Outcome Measures, Contacts/Locations v2
Primary completion datenot stated→2010-12
Completion date2007-12→2010-12
Secondary endpointsdetails revised at 1 of 1 entry
2006-04-26
Original filing
To assess the safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in the treatment of subjects with congenital AT-III deficiency.
Trial Details
NCT Number NCT00319228
Lead Sponsor Instituto Grifols, S.A.
Conditions Antithrombin III Deficiency
Enrollment 3 participants
Start Date 2008-04-15
Primary Completion 2011-12 (estimated)
Study Completion 2011-12-16 (estimated)
Updated on ClinicalTrials.gov 2026-10-07