An Early Phase 1 interventional study of Eptacog alfa, activated in Hemophilia A With Inhibitor and Hemophilia B With Inhibitor, sponsored by AryoGen Pharmed Co.. Completed at 1 site in Iran, Islamic Republic of. Open to male participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2022-09-10.
Sponsored by AryoGen Pharmed Co. · Early Phase 1, Interventional, and Treatment
Randomized, double-blind, single-dose, 5 ways crossover, exploratory clinical trial evaluating four different doses of AryoSeven (eptacog alfa, activated) and NovoSeven on selected pharmacodynamic parameters in patients with hemophilia with inhibitors.
Randomized, double-blind, single dose, 5 ways crossover, clinical trial evaluating four different doses (10 µg/kg, 30 µg/kg, 90 µg/kg, and 270 µg/kg) of AryoSeven (recombinant human FVII activated or eptacog alfa, activated) and one dose of NovoSeven (30 µg/kg) on selected pharmacodynamic parameters (PD) [Primary: Thrombin Generation Assay (TGA)] in male adult and adolescent (>12 years) patients with hemophilia A or B, with an inhibitors titer >5 Bethesda Units [BU] and not in bleeding status. This will be an exploratory study to evaluate dose-response relationship of PD markers as surrogate efficacy endpoints.
844 studies on the registry are indexed under Hemophilia A; 138 are open to participants now.
This study's enrollment of 14 is below the median of 30 across 499 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →AryoGen Pharmed Co. is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single dose, intravenously
Biological: Eptacog alfa, activated
Single dose, intravenously
Biological: Eptacog alfa, activated
Single dose, intravenously
Biological: Eptacog alfa, activated
Single dose, intravenously
Biological: Eptacog alfa, activated
Single dose, intravenously
Biological: Eptacog alfa, activated
A dose sequence for each injection will be randomly selected from the following doses: 10 μg/kg, 30 μg/kg, 90 μg/kg, or 270 μg/kg, separated by a wash-out period of 3 days.
Lag time of the thrombin generation curve
Time to 16.7% of peak plasmatic concentration, in minutes.
Time frame: Up to 30 hours after AryoSeven and NovoSeven injection
Endogenous Thrombin Potential (PD parameter)
Area under the curve plasma levels of thrombin generation curve (in nmol/per minute)
Time frame: Up to 30 hours after AryoSeven and NovoSeven injection
Time to Peak (PD parameter)
Time to Peak of thrombin generation curve (in minutes)
Time frame: Up to 30 hours after AryoSeven and NovoSeven injection
Peak height (PD parameter)
Peak height of thrombin generation curve (in nmol/ml)
Time frame: Up to 30 hours after AryoSeven and NovoSeven injection
F1.2 prothrombin fragments (PD parameter)
Peak height (micg/L)
Time frame: Up to 30 hours after AryoSeven and NovoSeven injection
D-dimer (PD parameter)
Peak height (micg/L)
Time frame: Up to 30 hours after AryoSeven and NovoSeven injection
AUCinf (PK parameter)
Area under the plasma concentration time curve from time 0 to infinity, based on the last observed concentration;
Time frame: Up to 30 hours after AryoSeven and NovoSeven injection
Cmax (PK parameter)
Observed maximum plasma concentration
Time frame: Up to 30 hours after AryoSeven and NovoSeven injection
Time of Cmax (PK parameter)
Time of observed maximum plasma concentration
Time frame: Up to 30 hours after AryoSeven and NovoSeven injection
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2020 to primary completion in Aug 2021, 7 months.
Of 37 industry-sponsored phase 1 interventional studies under Hemophilia A, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's 7 months is below that.
Counting every sponsor, half of 46 studies reached it within 13 months; a quarter within 7 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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AryoGen Pharmed Co.