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Trials |  |
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- || simoctocog alpha/von Willebrand Factor (OCTA101) / Octapharma
PK/PD data, Journal: Safety, pharmacokinetics and efficacy of a subcutaneous recombinant FVIII (OCTA101) in adult patients with severe haemophilia A. (Pubmed Central) - Nov 17, 2023
P1/2
Despite promising PK and efficacy results, the trial was terminated due to the incidence of FVIII inhibitors. The occurrence of inhibitors at two dose levels suggests that their development may be related to the subcutaneous route of administration.
- simoctocog alpha/von Willebrand Factor (OCTA101) / Octapharma
Safety and pharmacokinetics of a subcutaneous recombinant FVIII (OCTA101) in adult patients with severe haemophilia A (Exhibition) - May 13, 2022 - Abstract #ISTH2022ISTH_1531;
P1/2
Half-life and recovery were as expected from pre-clinical studies, and trough plasma FVIII levels ≥10% were achieved. Two patients developed inhibitory antibodies to OCTA101, and the trial was put on hold during discussion with the DMC.
- ||| simoctocog alpha/von Willebrand Factor (OCTA101) / Octapharma
Trial completion date, Trial termination, Trial primary completion date: Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A (clinicaltrials.gov) - Apr 8, 2022
P1/2, N=30, Terminated, Sponsor: Octapharma
Two patients developed inhibitory antibodies to OCTA101, and the trial was put on hold during discussion with the DMC. Trial completion date: Sep 2022 --> Feb 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2022 --> Feb 2022; Study was terminated due to SADRs
- | simoctocog alpha/von Willebrand Factor (OCTA101) / Octapharma
Enrollment closed: Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A (clinicaltrials.gov) - Aug 4, 2021
P1/2, N=36, Active, not recruiting, Sponsor: Octapharma
Trial completion date: Sep 2022 --> Feb 2022 | Active, not recruiting --> Terminated | Trial primary completion date: Sep 2022 --> Feb 2022; Study was terminated due to SADRs Recruiting --> Active, not recruiting
- || simoctocog alpha/von Willebrand Factor (OCTA101) / Octapharma
Enrollment open, Trial completion date, Trial primary completion date: Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A (clinicaltrials.gov) - Jan 22, 2021
P1/2, N=36, Recruiting, Sponsor: Octapharma
Recruiting --> Active, not recruiting Active, not recruiting --> Recruiting | Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Sep 2021 --> Sep 2022
- | simoctocog alpha/von Willebrand Factor (OCTA101) / Octapharma
Enrollment closed, Trial completion date, Trial primary completion date: Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A (clinicaltrials.gov) - Apr 2, 2020
P1/2, N=28, Active, not recruiting, Sponsor: Octapharma
Active, not recruiting --> Recruiting | Trial completion date: Sep 2021 --> Sep 2022 | Trial primary completion date: Sep 2021 --> Sep 2022 Recruiting --> Active, not recruiting | Trial completion date: Mar 2020 --> Sep 2021 | Trial primary completion date: Mar 2020 --> Sep 2021
- | simoctocog alpha/von Willebrand Factor (OCTA101) / Octapharma
New P1/2 trial: Safety and Pharmacokinetics of Subcutaneous Injection of OCTA101 in Adult Patients With Severe Hemophilia A (clinicaltrials.gov) - Aug 5, 2019
P1/2, N=28, Recruiting, Sponsor: Octapharma