Trial · NCT00623480

Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment

NCT00623480, Phase 3, Completed, Bayer; results first posted 2013-08-07

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment. Trials, record NCT00623480. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00623480

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Trial

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

Title: Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment
NCT number: NCT00623480
Status: Completed
Phases: Phase 3
Enrollment: 84 participants, actual
Lead sponsor: Bayer
Conditions: Hemophilia A
Interventions: Recombinant Factor VIII (Kogenate FS, BAY14-2222), Recombinant Factor VIII (Kogenate FS, BAY14-2222)
First posted: 2008-02-26
Last updated: 2014-11-17
Other registries' IDs: eudract:2008-000985-21
Results first posted: 2013-08-07

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Bleeding Frequency (Number of Total Bleeds)	After the last enrolled patient has been in the study for 1 year. At the cut-off, the median follow-up duration was 616 days (minimum was 111 days and maximum was 1109 days)
Secondary	Change From Baseline to 3 Years in the MRI (Magnetic Resonance Imaging) Scale.	Baseline and 3 years	The Extended MRI Scale total score has a range between 0 (normal unaffected joint) to 45 (maximal joint damage) points. It is composed of 2 domains, the soft tissue domain with a maximum of 9 points and the osteochondral domain with a maximum of 36 points. A single score for each subject was to be calculated from the sum of both domains and the average over all joints for the Extended MRI endpoint. Higher MRI score denotes greater joint structure damage thus a positive change from baseline means worsening.
Secondary	Change From Baseline to 3 Years in the Colorado Adult Joint Assessment Scale	Baseline and 3 years	The total joint score is derived for each of six joints: left and right sides for knees (score: 0-25), ankles (score: 0-25), and elbows (score: 0-21). Higher CAJAS (Colorado Adult Joint Assessment Scale) score denotes greater joint structure damage thus a positive change from baseline means worsening. CAJAS total score is the sum of all 6 joints, ranging from 0 (best possible outcome) to 142 (worst possible outcome).
Other	Change From Baseline to 3 Years in the Physical Functioning Domain of the Haemo-QoL-A	Baseline and 3 years	The Haemo-QoL-A total score as well as each of its domains have a range between 0 (worst Quality of Life) and 100 (best Quality of Life) points. Therefore, a higher Haemo-QoL-A score denotes greater Quality of Life.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Bleeding Frequency (Number of Total Bleeds)	After the last enrolled patient has been in the study for 1 year. At the cut-off, the median follow-up duration was 616 days (minimum was 111 days and maximum was 1109 days)	ITT (Intent-to-treat) Population	Bleeds	MEDIAN
SECONDARY	Change From Baseline to 3 Years in the MRI (Magnetic Resonance Imaging) Scale.	Baseline and 3 years	Full Analysis Set	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to 3 Years in the Colorado Adult Joint Assessment Scale	Baseline and 3 years	Full Analysis Set	Scores on a scale	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Change From Baseline to 3 Years in the Physical Functioning Domain of the Haemo-QoL-A	Baseline and 3 years	Full Analysis Set	Scores on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Bleeding Frequency (Number of Total Bleeds)	Recombinant Factor VIII Prophylaxis Treatment	0	Full Range 0 to 57	Bleeds
Bleeding Frequency (Number of Total Bleeds)	Recombinant Factor VIII On-demand Treatment	54.5	Full Range 0 to 149	Bleeds
Change From Baseline to 3 Years in the MRI (Magnetic Resonance Imaging) Scale.	Recombinant Factor VIII Prophylaxis Treatment	0.79	95% Confidence Interval 0.27 to 1.32	Scores on a scale
Change From Baseline to 3 Years in the MRI (Magnetic Resonance Imaging) Scale.	Recombinant Factor VIII On-demand Treatment	0.96	95% Confidence Interval 0.34 to 1.58	Scores on a scale
Change From Baseline to 3 Years in the Colorado Adult Joint Assessment Scale	Recombinant Factor VIII Prophylaxis Treatment	-0.31	95% Confidence Interval -0.79 to 0.18	Scores on a scale
Change From Baseline to 3 Years in the Colorado Adult Joint Assessment Scale	Recombinant Factor VIII On-demand Treatment	0.63	95% Confidence Interval 0.08 to 1.18	Scores on a scale
Change From Baseline to 3 Years in the Physical Functioning Domain of the Haemo-QoL-A	Recombinant Factor VIII Prophylaxis Treatment	7.86	95% Confidence Interval 1.79 to 13.92	Scores on a scale
Change From Baseline to 3 Years in the Physical Functioning Domain of the Haemo-QoL-A	Recombinant Factor VIII On-demand Treatment	-5.30	95% Confidence Interval -11.97 to 1.37	Scores on a scale

Source ClinicalTrials.gov

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Recombinant Factor VIII Prophylaxis Treatment	42
Overall Study	STARTED	Recombinant Factor VIII On-demand Treatment	42
Overall Study	COMPLETED	Recombinant Factor VIII Prophylaxis Treatment	35
Overall Study	COMPLETED	Recombinant Factor VIII On-demand Treatment	35
Overall Study	NOT COMPLETED	Recombinant Factor VIII Prophylaxis Treatment	7
Overall Study	NOT COMPLETED	Recombinant Factor VIII On-demand Treatment	7

Source ClinicalTrials.gov

Adverse events82

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	Dental caries	Gastrointestinal disorders	Recombinant Factor VIII Prophylaxis Treatment	0	42	0
other	Dental caries	Gastrointestinal disorders	Recombinant Factor VIII On-demand Treatment	3	42	3
other	Dyspepsia	Gastrointestinal disorders	Recombinant Factor VIII Prophylaxis Treatment	0	42	0
other	Dyspepsia	Gastrointestinal disorders	Recombinant Factor VIII On-demand Treatment	3	42	3
other	Toothache	Gastrointestinal disorders	Recombinant Factor VIII Prophylaxis Treatment	3	42	3
other	Toothache	Gastrointestinal disorders	Recombinant Factor VIII On-demand Treatment	2	42	3
other	Pyrexia	General disorders	Recombinant Factor VIII Prophylaxis Treatment	1	42	2
other	Pyrexia	General disorders	Recombinant Factor VIII On-demand Treatment	5	42	6
other	Influenza	Infections and infestations	Recombinant Factor VIII Prophylaxis Treatment	2	42	2
other	Influenza	Infections and infestations	Recombinant Factor VIII On-demand Treatment	7	42	7

1 to 10 of 82Source ClinicalTrials.gov

See all 82 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Recombinant Factor VIII Prophylaxis Treatment
Total, all-cause mortality	Recombinant Factor VIII On-demand Treatment
Total, other adverse events	Recombinant Factor VIII Prophylaxis Treatment	11	42
Total, other adverse events	Recombinant Factor VIII On-demand Treatment	28	42
Total, serious adverse events	Recombinant Factor VIII Prophylaxis Treatment	9	42
Total, serious adverse events	Recombinant Factor VIII On-demand Treatment	11	42

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23528101	RESULT	PubMed
28836341	DERIVED	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 comparisons1

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

Comparison
Recombinant Factor VIII Prophylaxis Treatment vs Recombinant Factor VIII On-demand Treatment: serious adverse events

Source Trial comparisons

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/NCT00623480

GET https://conductscience.org/api/trials/v1/NCT00623480/events?page=2

API reference For AI assistants