A Phase 3 interventional study of Human Coagulation FACTOR X in Factor X Deficiency, sponsored by Bio Products Laboratory. Completed at 14 sites in 5 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2014-12-12.
Sponsored by Bio Products Laboratory · Phase 3, Interventional, and Treatment
The main objective of the study is to assess the pharmacokinetics of FACTOR X after a single dose of 25IU/kg.
The secondary objectives of the study are to assess efficacy and safety of FACTOR X in the treatment of bleeding episodes over at least 6 months.
Bio Products Laboratory is the lead sponsor of 27 studies on the registry; none are 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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: Human Coagulation FACTOR X
Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
FX:C Incremental Recovery
Incremental recovery is defined as the peak rise in plasma FX levels (IU/dL), as measured at 15, 30 and 60 minutes post-dose, divided by the dose (IU/kg). Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment
Time frame: At Baseline (during first 60 minutes post-dose) and at 6 months post-Baseline (during first 60 minutes post-dose)
FX:C Half-life
Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment
Time frame: At Baseline and at 6 months post-Baseline
| Milestone | Human Coagulation FACTOR X |
|---|---|
| Started | 16 |
| Completed | 15 |
| Not completed | 1 |
| Withdrew: Death | 1 |
Incremental recovery is defined as the peak rise in plasma FX levels (IU/dL), as measured at 15, 30 and 60 minutes post-dose, divided by the dose (IU/kg). Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment
| IU/dL per IU/kg | Human Coagulation FACTOR X |
|---|---|
| FX:C Incremental Recovery | 2.07 ± 21.01 |
Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment
| hours | Human Coagulation FACTOR X |
|---|---|
| FX:C Half-life | 29.36 ± 22.89 |
Collected over From signing of informed consent form until 28 days post-last dose.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Human Coagulation FACTOR X | — | 6/16 (37.5%) | 15/16 (93.8%) |
| Event | Human Coagulation FACTOR X |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 2/16 |
| Post procedural haemorrhageInjury, poisoning and procedural complications | 1/16 |
| DysmenorrhoeaReproductive system and breast disorders | 1/16 |
| MenorrhagiaReproductive system and breast disorders | 1/16 |
| Back painMusculoskeletal and connective tissue disorders | 1/16 |
| Muscle haemorrhageMusculoskeletal and connective tissue disorders | 1/16 |
| PneumoniaInfections and infestations | 1/16 |
| Nosocomial infectionInfections and infestations | 1/16 |
| Tooth abscessInfections and infestations | 1/16 |
| GastritisGastrointestinal disorders | 1/16 |
| Event | Human Coagulation FACTOR X |
|---|---|
| HeadacheNervous system disorders | 8/16 |
| NasopharyngitisInfections and infestations | 7/16 |
| Back painMusculoskeletal and connective tissue disorders | 6/16 |
| Pain in extremityMusculoskeletal and connective tissue disorders | 6/16 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/16 |
| HypotensionVascular disorders | 4/16 |
| Upper respiratory tract infectionInfections and infestations | 4/16 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 3/16 |
| UlcerGeneral disorders | 2/16 |
| Joint injuryInjury, poisoning and procedural complications | 2/16 |
| Age, Categorical(Participants) | Human Coagulation FACTOR X |
|---|---|
| <=18 years | 6 |
| Between 18 and 65 years | 10 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Human Coagulation FACTOR X |
|---|---|
| Female | 10 |
| Male | 6 |
| Region of Enrollment(participants) | Human Coagulation FACTOR X |
|---|---|
| United States | 2 |
| Spain | 4 |
| Turkey | 6 |
| Germany | 1 |
| United Kingdom | 3 |
The record gives a start of Jan 2010, a primary completion of Nov 2013 and a completion of Nov 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Dec 2014, 1 year 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Factor X
Factor X Deficiency
Bio Products Laboratory