NEWS HIGHLIGHTS
Published Studies Related to Cinryze (Human c1-Esterase Inhibitor)
Cinryze (C1-inhibitor) for the treatment of hereditary angioedema. [2011]
Cinryze is a pasteurized, nanofiltered plasma derived concentrate of C1-inhibitor
(pdC1-INH) licensed for the prophylactic treatment of hereditary angioedema. In a
double-blind placebo-controlled crossover trial to evaluate Cinryze as
prophylaxis, the frequency of attacks was halved (6.26 per 12 weeks on Cinryze
versus 12.73 per 12 weeks on placebo)...
Nanofiltered human C1 inhibitor concentrate (Cinryze(R)): in hereditary angioedema. [2011.10.01]
Intravenous nanofiltered human C1 inhibitor (C1-INH NF) concentrate (Cinryze(R)) is used as a direct replacement of deficient levels of plasma C1 inhibitor in patients with hereditary angioedema (HAE). In the EU, C1-INH NF concentrate 1000 U is indicated in the treatment, pre-procedural prevention, and routine prevention of angioedema attacks in adults and adolescents with HAE...
Clinical Trials Related to Cinryze (Human c1-Esterase Inhibitor)
C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica Exacerbation [Recruiting]
The overall objective is to evaluate the tolerability/safety and preliminary efficacy of
CINRYZEŽ (C1 esterase inhibitor [human]) as add-on therapy for treatment of acute optic
neuritis and/or transverse myelitis in NMO and NMOSD.
Primary Objective: To evaluate the safety and tolerability of 3-5 doses of 1000 - 2000 Units
intravenous CINRYZE in NMO/NMOSD patients during an acute exacerbation.
Secondary Objectives:
- To determine the frequency of adverse events with CINRYZE in this patient population.
- To determine the effect of CINRYZE on NMO clinical scores (Expanded Disability Status
Scale and Low Contrast Visual Acuity).
- To compare the change in MRI lesion size and extent following a course of CINRYZE.
Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks [Recruiting]
The primary objectives of the study are to evaluate the safety, tolerability, and efficacy
of two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by
subcutaneous (SC) injection to prevent angioedema attacks.
Cinryze for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12 [Recruiting]
The objectives of the study are to:
1. Evaluate the dose response and the pharmacokinetics (PK)/pharmacodynamics (PD) of
intravenous (IV) administration of Cinryze for the treatment of acute angioedema
attacks in children above and below 25 kg and less than 12 years of age with Hereditary
Angioedema (HAE).
2. Determine the safety and tolerability following IV administration of Cinryze in this
study population.
A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE (C1 Inhibitor [Human]) [Recruiting]
A Study to Evaluate the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Subcutaneous Cinryze Administration [Recruiting]
The objectives of the study are to:
1. Evaluate the safety and tolerability of Cinryze administered by subcutaneous injection
in patients with Hereditary Angioedema (HAE)
2. Characterize the PK and PD of Cinryze administered by subcutaneous injection
3. Assess the immunogenicity of Cinryze following subcutaneous administration
Reports of Suspected Cinryze (Human c1-Esterase Inhibitor) Side Effects
Hereditary Angioedema (109),
Inappropriate Schedule of Drug Administration (40),
Device Related Infection (32),
OFF Label USE (26),
Angioedema (25),
Headache (23),
Infusion Related Reaction (22),
Drug Dose Omission (17),
Convulsion (17),
Maternal Exposure During Pregnancy (16), more >>
|
