Study of Pharmacokinetic-guided dosing of clottiing factor in Hemophilia.

"OPTI-CLOT": Peri-Operative PharmacokineTIc-guided dosing of CLOTting factor in Hemophilia. - OPTICLOT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-000909-24-NL

Enrollment

Registered

2013-05-24

Start date

2013-08-29

Completion date

Unknown

Last updated

2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemophillia MedDRA version: 20.0 Level: LLT Classification code 10066439 Term: Hemophilia System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10060613 Term: Hemophilia A (Factor VIII) System Organ Class: 100000004850 MedDRA version: 20.0 Level: LLT Classification code 10060614 Term: Hemophilia B (Factor IX) System Organ Class: 100000004850

Interventions

Trade Name: Advate Pharmaceutical Form: Powder and solvent for solution for injection Trade Name: Kogenate Pharmaceutical Form: Powder and solvent for solution for injection Trade Name: Helixate Nex

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: - Severe and moderate hemophilia A or B (FVIII/FIX plasma level = 5%) - Elective and low or medium risk surgery as defined by surgical risk score (form B) - = 12 years of age at inclusion date for the randomized controlled trial; - =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Patients with other congenital or acquired hemostatic abnormalities. - Withdrawal of (parental) informed consent. - Detectable FVIII/FIX inhibiting antibodies (>0.02 BU) at inclusion in study. - General medical conditions which may interfere with participation in the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To investigate whether peri-operative dosing using a population-based pharmacokinetic model (non-linear mixed effect modelling) in hemophilia patients leads to a significant reduction in clotting factor consumption in comparison to the standard dosing procedure, without an increase in bleeding risk. ;Secondary Objective: 1. Peri-operative hemostasis as quantified by hemoglobin values pre- and postoperative, blood loss and classification of expected blood loss during surgical procedure as documented by standardized form. 2. Achieved FVIII/FIX levels after recombinant FVIII/FIX infusion (IU ml-1) 3. Length of hospitalization (days). 4. Effect of baseline VWF antigen, propeptide values and blood type on FVIII/FIX clearance. 5. Economic evaluation. ;Primary end point(s): 1. Amount of infused FVIII/FIX concentrate per kilogram during peri-operative period per postoperative day (0-14 days after day of surgery). ;Timepoint(s) of evaluation of this end point: After 14 days	—

Measure

Time frame

Main Objective: 1. To investigate whether peri-operative dosing using a population-based pharmacokinetic model (non-linear mixed effect modelling) in hemophilia patients leads to a significant reduction in clotting factor consumption in comparison to the standard dosing procedure, without an increase in bleeding risk. ;Secondary Objective: 1. Peri-operative hemostasis as quantified by hemoglobin values pre- and postoperative, blood loss and classification of expected blood loss during surgical procedure as documented by standardized form. 2. Achieved FVIII/FIX levels after recombinant FVIII/FIX infusion (IU ml-1) 3. Length of hospitalization (days). 4. Effect of baseline VWF antigen, propeptide values and blood type on FVIII/FIX clearance. 5. Economic evaluation. ;Primary end point(s): 1. Amount of infused FVIII/FIX concentrate per kilogram during peri-operative period per postoperative day (0-14 days after day of surgery). ;Timepoint(s) of evaluation of this end point: After 14 days

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Secondary

Measure	Time frame
Secondary end point(s): 1. Peri-operative hemostasis quantified by standardized form (form A). 2. Achieved FVIII/FIX levels (IU ml-1) after recombinant FVIII/FIX infusion. 3. Duration of hospitalization(day of release – day of surgery/ start of continuous or bolus FVIII/FIX infusion). 4. Effect of baseline VWF antigen, propeptide values and blood type on FVIII/FIX clearance. 5. Economic analysis of costs in both treatment arms, differentiation between bolus and continuous infusion. ;Timepoint(s) of evaluation of this end point: Within 6 months of last patient last visit	—

Measure

Time frame

Secondary end point(s): 1. Peri-operative hemostasis quantified by standardized form (form A). 2. Achieved FVIII/FIX levels (IU ml-1) after recombinant FVIII/FIX infusion. 3. Duration of hospitalization(day of release – day of surgery/ start of continuous or bolus FVIII/FIX infusion). 4. Effect of baseline VWF antigen, propeptide values and blood type on FVIII/FIX clearance. 5. Economic analysis of costs in both treatment arms, differentiation between bolus and continuous infusion. ;Timepoint(s) of evaluation of this end point: Within 6 months of last patient last visit

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Countries

Netherlands

Contacts

Public ContactI. van Vliet

Erasmus MC

i.vanvliet@erasmusmmc.nl0031107036140

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026