NCT01095497 is a Phase 2 clinical trial of CINRYZE in Hereditary Angioedema, sponsored by Shire.

Who is sponsoring NCT01095497?

NCT01095497 is sponsored by Shire.

What drugs are being tested in NCT01095497?

Interventions in NCT01095497: CINRYZE.

What condition does NCT01095497 study?

NCT01095497 studies Hereditary Angioedema.

Is NCT01095497 still recruiting?

NCT01095497 is currently completed. Last updated 9 July 2021.

Are results published for NCT01095497?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-07-09 · How we verify

NCT01095497

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration

Completed Phase 2 Results posted Last updated 9 July 2021

What this trial tests

Phase 2 trial testing CINRYZE in Hereditary Angioedema in 26 participants. Completed in 16 December 2010.

Timeline

7 June 2010

Primary endpoint
16 December 2010

16 December 2010

Quick facts

Lead sponsor	Shire
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	26
Start date	7 June 2010
Primary completion	16 December 2010
Estimated completion	16 December 2010
Sites	7 locations across United States

Drugs / interventions tested

CINRYZE — full drug profile →

Conditions studied

Hereditary Angioedema — all drugs for Hereditary Angioedema →

Sponsor

Shire — full company profile →

Who can join

12 and older, any sex, with Hereditary Angioedema. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. Primary · 18 days in each treatment period

Number of subjects with adverse events

Group	Value	95% CI
Intravenous (IV) CINRYZE	12	± 0.019
Subcutaneous (SC) CINRYZE Dose 1	10	± 0.027
SC CINRYZE Dose 2	11	± 0.010

Number of subjects with injection site reactions

Group	Value	95% CI
Intravenous (IV) CINRYZE	1	± 0.033
Subcutaneous (SC) CINRYZE Dose 1	10	± 0.032
SC CINRYZE Dose 2	11	± 0.010

Number of subjects who discontinued study drug

Group	Value	95% CI
Intravenous (IV) CINRYZE	1
Subcutaneous (SC) CINRYZE Dose 1	0
SC CINRYZE Dose 2	0

Number of subjects who withdrew from the study

Group	Value	95% CI
Intravenous (IV) CINRYZE	1
Subcutaneous (SC) CINRYZE Dose 1	1
SC CINRYZE Dose 2	0

Mean Change C1 Inhibitor (C1INH) Secondary · 18 days in each treatment period

Mean Change in Baseline in Observed Plasma Concentration of C1 Inhibitor (C1INH) Antigen. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.

1 hour (h) post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	0.075	± 0.023
Subcutaneous (SC) CYNRYZE Dose 1	-0.002	± 0.008
SC Dose 2	-0.001	± 0.006

2 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	0.070	± 0.021
Subcutaneous (SC) CYNRYZE Dose 1	-0.002	± 0.008
SC Dose 2	-0.001	± 0.004

3 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	0.070	± 0.023
Subcutaneous (SC) CYNRYZE Dose 1	-0.002	± 0.007
SC Dose 2	-0.002	± 0.007

4 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	0.065	± 0.022
Subcutaneous (SC) CYNRYZE Dose 1	0.003	± 0.005
SC Dose 2	0.003	± 0.007

6 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	0.064	± 0.018
Subcutaneous (SC) CYNRYZE Dose 1	0.002	± 0.009
SC Dose 2	0.006	± 0.007

8 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	0.062	± 0.019
Subcutaneous (SC) CYNRYZE Dose 1	0.003	± 0.010
SC Dose 2	0.009	± 0.008

24 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	0.049	± 0.016
Subcutaneous (SC) CYNRYZE Dose 1	0.016	± 0.023
SC Dose 2	0.021	± 0.011

48 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	0.035	± 0.017
Subcutaneous (SC) CYNRYZE Dose 1	0.019	± 0.030
SC Dose 2	0.028	± 0.009

Mean Change C4 Compliment Secondary · 18 days in each treatment period

Mean Change in Baseline in Observed Plasma Concentration of C4 Compliment. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.

1 hour (h) post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	-7.5	± 15.4
Subcutaneous (SC) CYNRYZE Dose 1	-12.9	± 15.6
SC Dose 2	0.1	± 8.0

2 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	-0.6	± 10.2
Subcutaneous (SC) CYNRYZE Dose 1	-3.8	± 18.2
SC Dose 2	-3.3	± 8.9

3 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	-1.3	± 13.5
Subcutaneous (SC) CYNRYZE Dose 1	-0.6	± 10.9
SC Dose 2	2.5	± 11.1

4 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	2.7	± 14.8
Subcutaneous (SC) CYNRYZE Dose 1	-5.3	± 18.5
SC Dose 2	8.8	± 23.7

6 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	12.0	± 24.8
Subcutaneous (SC) CYNRYZE Dose 1	-0.6	± 37.1
SC Dose 2	8.1	± 21.0

8 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	13.0	± 20.7
Subcutaneous (SC) CYNRYZE Dose 1	-8.2	± 24.6
SC Dose 2	11.2	± 27.4

24 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	25.5	± 30.3
Subcutaneous (SC) CYNRYZE Dose 1	2.9	± 25.4
SC Dose 2	14.3	± 12.7

48 h post Dose 1

Group	Value	95% CI
Intravenous (IV) CINRYZE	31.0	± 25.3
Subcutaneous (SC) CYNRYZE Dose 1	6.2	± 23.1
SC Dose 2	23.3	± 18.0

Number of Participants With C1 Inhibitor (INH) Antibodies Secondary · 18 days in each treatment period

Group	Value	95% CI
Intravenous (IV) CINRYZE	0
Subcutaneous (SC) CINRYZE Dose 1	0
SC CINRYZE Dose 2	0

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intravenous (IV) CINRYZE

Serious: 0/26 (0%)

Deaths: —

Subcutaneous (SC) CINRYZE Dose 1

Serious: 0/13 (0%)

Deaths: —

SC CINRYZE Dose 2

Serious: 0/12 (0%)

Deaths: —

Other adverse events (9 terms — click to expand)

Reaction	System	Intravenous (IV) CINRYZE	Subcutaneous (SC) CINRYZE …	SC CINRYZE Dose 2
Injection site pain	General disorders	—	—	—
Hereditary angioedema	Congenital, familial and genetic disorders	—	—	—
Injection site erythema	General disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Injection site hematoma	General disorders	—	—	—
Injection site pruritus	General disorders	—	—	—
Acne cystic	Skin and subcutaneous tissue disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Injection site swelling	General disorders	—	—	—

Data from ClinicalTrials.gov NCT01095497 adverse events section.

Sponsor's own description

The objectives of the study are to: 1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema 2. Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection 3. Assess the immunogenicity of CINRYZE following subcutaneous administration

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Emerging Therapies in Hereditary Angioedema.
Chen M, Riedl MA. · · 2017 · cited 21× · PMID 28687111 · DOI 10.1016/j.iac.2017.03.003

Verify or expand the search:

Other trials of CINRYZE

Trials testing the same drug.

NCT01095510 — CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12 · Phase 2 · completed

Other recruiting trials for Hereditary Angioedema

Currently open trials in the same condition.

NCT06960213 — STOP-HAE: A Phase 3 Study of ADX-324 in HAE · Phase 3 · recruiting
NCT06806657 — Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab · Phase 4 · recruiting
NCT06573723 — Institutional Registry of Rare Diseases · recruiting
NCT05691361 — Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients · Phase 1, PHASE2 · active not recruiting
NCT05505916 — An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angio · Phase 3 · active not recruiting

Other Shire trials

Trials by the same sponsor.

NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India · Phase 4 · recruiting
NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism · Phase 3 · withdrawn
NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease · Phase 3 · terminated
NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India · completed
NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study · Phase 4 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01095497 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 9 July 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01095497.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01095497

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of CINRYZE

Other recruiting trials for Hereditary Angioedema

Other Shire trials

Verify against primary sources