TIBOHCA: A phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-Iminobiotin (2-IB) after out of hospital cardiac arrest

TIBOHCA: A phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-Iminobiotin (2-IB) after out of hospital cardiac arrest - TIBOHCA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47307

Enrollment

Registered

2016-03-15

Start date

2016-05-17

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

postanoxic encephalopathy

Interventions

The first cohort of eight patients will receive 2-IB in a dose of 0,055 mg/kg/dose every 4 h iv, 6 times (part A). In part B the second cohort of eight patients will receive a dose based on the kidn

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Admission to the ICU after OHCA and successful CPR due to a cardiac cause * Duration of resuscitation no longer than 30 minutes * Shockable rhythm as presenting rhythm * Post anoxic coma on admission * Ability to start study medication within 6 hours after cardiac arrest * Age 18 years or older * Eligible for treatment with a target temperature management of 36° C

Exclusion criteria

Exclusion criteria: * No informed consent * Known co-morbidity with a life expectancy of

Design outcomes

Primary

Measure	Time frame
The main study parameters used for evaluating the short term safety and tolerability will be vital signs ((heart frequency and blood pressure) before and until 15 minutes after administration of the study drug and the need for intervention), biochemistry and haematology taken as part of the clinical protocol, and the occurrence of (Serious) Adverse Events ((S)AEs) until a maximum of 7 days on the ICU or until discharge from the ICU, whichever occurs earlier. For evaluation of the pharmacokinetics profile of 2-IB six plasma samples will be taken and analysed. Pharmacokinetic parameters to be determined will include Cmax, AUC, Tmax, t1/2, clearance (Cl), and volume of distribution (Vd).	—

Measure

Time frame

The main study parameters used for evaluating the short term safety and tolerability will be vital signs ((heart frequency and blood pressure) before and until 15 minutes after administration of the study drug and the need for intervention), biochemistry and haematology taken as part of the clinical protocol, and the occurrence of (Serious) Adverse Events ((S)AEs) until a maximum of 7 days on the ICU or until discharge from the ICU, whichever occurs earlier. For evaluation of the pharmacokinetics profile of 2-IB six plasma samples will be taken and analysed. Pharmacokinetic parameters to be determined will include Cmax, AUC, Tmax, t1/2, clearance (Cl), and volume of distribution (Vd).

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Secondary

Measure	Time frame
Secondary parameters that will be evaluated: 1. Short term efficacy as determined by biochemical markers NSE and s100b at 24h and 48h after OHCA. 2. Longer term safety as determined by the occurrence of SAEs until 30 days after OHCA including death. 3. Longer term efficacy as determined by the Cerebral Performance Category (CPC) and IQCODE at 30 days after OHCA or alternatively the Adult Lifestyles and Function Interview (ALFI) scale (by telephone).	—

Measure

Time frame

Secondary parameters that will be evaluated: 1. Short term efficacy as determined by biochemical markers NSE and s100b at 24h and 48h after OHCA. 2. Longer term safety as determined by the occurrence of SAEs until 30 days after OHCA including death. 3. Longer term efficacy as determined by the Cerebral Performance Category (CPC) and IQCODE at 30 days after OHCA or alternatively the Adult Lifestyles and Function Interview (ALFI) scale (by telephone).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)