Trial · NCT00930176

A Study Investigating Treatment Factor X in People With Factor X Deficiency

NCT00930176, Phase 3, Completed, Bio Products Laboratory; results first posted 2014-12-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Study Investigating Treatment Factor X in People With Factor X Deficiency. Trials, record NCT00930176. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00930176

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study Investigating Treatment Factor X in People With Factor X Deficiency
NCT number: NCT00930176
Status: Completed
Phases: Phase 3
Enrollment: 16 participants, actual
Lead sponsor: Bio Products Laboratory
Conditions: Factor X Deficiency
Interventions: Human Coagulation FACTOR X
First posted: 2009-06-30
Last updated: 2014-12-12
Results first posted: 2014-12-12

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	FX:C Incremental Recovery	At Baseline (during first 60 minutes post-dose) and at 6 months post-Baseline (during first 60 minutes post-dose)	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
Primary	FX:C Half-life	At Baseline and at 6 months post-Baseline	Value given is the mean of 31 results: 16 for Baseline Visit + 15 for Repeat PK assessment

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	FX:C Incremental Recovery	At Baseline (during first 60 minutes post-dose) and at 6 months post-Baseline (during first 60 minutes post-dose)		IU/dL per IU/kg	GEOMETRIC_MEAN
PRIMARY	FX:C Half-life	At Baseline and at 6 months post-Baseline		hours	GEOMETRIC_MEAN

Source ClinicalTrials.gov

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
FX:C Incremental Recovery	Human Coagulation FACTOR X		2.07	Geometric Coefficient of Variation 21.01	IU/dL per IU/kg
FX:C Half-life	Human Coagulation FACTOR X		29.36	Geometric Coefficient of Variation 22.89	hours

Source ClinicalTrials.gov

Participant flow3

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Human Coagulation FACTOR X	16
Overall Study	COMPLETED	Human Coagulation FACTOR X	15
Overall Study	NOT COMPLETED	Human Coagulation FACTOR X	1

Source ClinicalTrials.gov

Adverse events77

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Haematoma	Vascular disorders	Human Coagulation FACTOR X	1	16	2
other	Hypotension	Vascular disorders	Human Coagulation FACTOR X	4	16	4
other	Urticaria	Immune system disorders	Human Coagulation FACTOR X	1	16	2
other	Fatigue	General disorders	Human Coagulation FACTOR X	1	16	2
other	Infusion site erytema	General disorders	Human Coagulation FACTOR X	1	16	2
other	Infusion site pain	General disorders	Human Coagulation FACTOR X	1	16	1
other	Malaise	General disorders	Human Coagulation FACTOR X	1	16	2
other	Non-cardiac chest pain	General disorders	Human Coagulation FACTOR X	1	16	1
other	Oedema peripheral	General disorders	Human Coagulation FACTOR X	1	16	2
other	Pyrexia	General disorders	Human Coagulation FACTOR X	1	16	2

1 to 10 of 77Source ClinicalTrials.gov

See all 77 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Human Coagulation FACTOR X
Total, other adverse events	Human Coagulation FACTOR X	15	16
Total, serious adverse events	Human Coagulation FACTOR X	6	16

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29545231	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00930176

GET https://conductscience.org/api/trials/v1/NCT00930176/events?page=2

API reference For AI assistants