Trial · NCT00225147

Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

NCT00225147, Phase 2, Phase 3, Completed, Pharming Technologies B.V.; results first posted 2012-08-31

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema. Trials, record NCT00225147. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00225147

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Trial

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

Title: Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
NCT number: NCT00225147
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 77 participants, actual
Lead sponsor: Pharming Technologies B.V.
Conditions: Hereditary Angioedema, Angioneurotic Edema
Interventions: Recombinant Human C1 Inhibitor, placebo
First posted: 2005-09-23
Last updated: 2013-02-22
Results first posted: 2012-08-31

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Time to Beginning of Relief of Symptoms	up to 48 hours after study drug administration	The time to beginning of relief of symptoms at the location that showed the first visual analogue scale ("VAS") score decrease of at least 20 mm from baseline score with persistence to the next timepoint, assessment timepoints were taken on pre-scheduled time-points after study drug administration: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours. Time to beginning of relief has been calculated as median time, by using the exact timepoints on which each assessment was performed.
Secondary	Time to Minimal Symptoms	up to 48 hours after study drug administration	The time to minimal symptoms was the time to minimal symptoms for an attack, assessed using the Visual Analogue Scale ("VAS") score. Symptoms were said to be minimal when the "VAS" score at all locations was below 20 mm. Assessment timepoints were: baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours and 48 hours. Time to minimal symtoms has been calculated by using the exact timepoints on which each assessment was performed.

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	Time to Beginning of Relief of Symptoms	up to 48 hours after study drug administration	The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration.	minutes	MEDIAN
SECONDARY	Time to Minimal Symptoms	up to 48 hours after study drug administration	The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration.	minutes	MEDIAN

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
Time to Beginning of Relief of Symptoms	100 IU/kg rhC1INH	68	Full Range 55 to 285	minutes
Time to Beginning of Relief of Symptoms	50 IU/kg rhC1INH	122	Full Range 29 to 250	minutes
Time to Beginning of Relief of Symptoms	Placebo	258	Full Range 30 to 721	minutes
Time to Beginning of Relief of Symptoms	50 IU/kg Open-label rhC1INH	62.5	Full Range 15 to 1499	minutes
Time to Minimal Symptoms	100 IU/kg rhC1INH	245	Full Range 125 to 270	minutes
Time to Minimal Symptoms	50 IU/kg rhC1INH	246.5	Full Range 243 to 484	minutes
Time to Minimal Symptoms	Placebo	1101	Full Range 970 to 1494	minutes
Time to Minimal Symptoms	50 IU/kg Open-label rhC1INH	145	Full Range 124 to 256	minutes

Source ClinicalTrials.gov

Participant flow24

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

Period	Milestone	Group	Participants
Double-blind Phase	STARTED	100 IU/kg rhC1INH	13
Double-blind Phase	STARTED	50 IU/kg rhC1INH	12
Double-blind Phase	STARTED	Placebo	13
Double-blind Phase	STARTED	50 IU/kg Open-label rhC1INH	0
Double-blind Phase	COMPLETED	100 IU/kg rhC1INH	13
Double-blind Phase	COMPLETED	50 IU/kg rhC1INH	12
Double-blind Phase	COMPLETED	Placebo	13
Double-blind Phase	COMPLETED	50 IU/kg Open-label rhC1INH	0
Double-blind Phase	NOT COMPLETED	100 IU/kg rhC1INH	0
Double-blind Phase	NOT COMPLETED	50 IU/kg rhC1INH	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events68

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	back pain	Musculoskeletal and connective tissue disorders	100 IU/kg rhC1INH	0	13	0
other	back pain	Musculoskeletal and connective tissue disorders	50 IU/kg rhC1INH	1	12	1
other	back pain	Musculoskeletal and connective tissue disorders	Placebo	0	13	0
other	back pain	Musculoskeletal and connective tissue disorders	50 IU/kg Open-label rhC1INH	0	62	0
other	headache	Nervous system disorders	100 IU/kg rhC1INH	2	13	2
other	headache	Nervous system disorders	50 IU/kg rhC1INH	0	12	0
other	headache	Nervous system disorders	Placebo	0	13	0
other	headache	Nervous system disorders	50 IU/kg Open-label rhC1INH	12	62	23
other	injection site swelling	General disorders	100 IU/kg rhC1INH	0	13	0
other	injection site swelling	General disorders	50 IU/kg rhC1INH	0	12	0

1 to 10 of 68Source ClinicalTrials.gov

See all 68 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	100 IU/kg rhC1INH
Total, all-cause mortality	50 IU/kg rhC1INH
Total, all-cause mortality	Placebo
Total, all-cause mortality	50 IU/kg Open-label rhC1INH
Total, other adverse events	100 IU/kg rhC1INH	2	13
Total, other adverse events	50 IU/kg rhC1INH	2	12
Total, other adverse events	Placebo	3	13
Total, other adverse events	50 IU/kg Open-label rhC1INH	18	62
Total, serious adverse events	100 IU/kg rhC1INH	0	13
Total, serious adverse events	50 IU/kg rhC1INH	0	12

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
20920772	RESULT	PubMed
23535096	DERIVED	PubMed
28284978	DERIVED	PubMed
42159953	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 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.

Source

Release: trials-2026-11-12-0.4.0
Release manifest SHA-256: 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
Registry capture: 2026-11-12
Results copy, AACT: 2026-03-23
NIH clinical studies file: 2026-11-13

Source ClinicalTrials.gov

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone 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

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

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