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NCT00097695·Phase 3·INTERVENTIONAL

Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema

IcatibantOtherCompleted

Status

Completed

Phase

Phase 3

Enrollment

84

Locations

1

Results

Posted

Publications

2

Study summary

What the protocol is testing.

The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema (HAE).

Full detailed description

This Phase II/III study consisted of two parts: A controlled phase and An Open label extension(OLE) phase. The controlled phase describes the double blind part of the study and was intended to evaluate the efficacy of icatibant in decreasing the time to onset of symptom relief compared with placebo for the first treated cutaneous and/or abdominal attack in randomised patients. Patients experienced a laryngeal attack were not randomised, but treated with open label icatibant according to the controlled phase procedures and assessments. The outcome of this group was to be reported descriptively. After treatment of the first attack in the controlled phase, the patients were eligible to enter the OLE phase. In the OLE phase, patients who experienced angioedema attacks severe enough to warrant treatment were to be treated with s.c. icatibant as appropriate until the end of the study.The OLE phase became a modified open label extension where all 56 patients who had been randomised and the last randomised patient had concluded the double-blind phase. The modified open label extension period permitted treatment for patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the double blind phase was still ongoing.

Interventions

Treatment arms and agents.

DRUG

Icatibant

30 mg (3mL) subcutaneous icatibant injection in the abdominal region

DRUG

Placebo

Solution for injection, matched to study drug Single dose: 3 mL

Timeline

From registration to results.

  1. First posted

    Nov 29, 2004

  2. Study start

    Dec 28, 2004

  3. Primary completion

    Jul 17, 2006

  4. Study completion

    Jul 17, 2006

  5. Results posted

    Dec 24, 2013

  6. Registry updated

    Jun 9, 2021

Outcomes

What the study measures.

Primary outcomes

Time to Onset of Symptom Relief (TOSR)

Time frame · 5 days

The primary efficacy endpoint was TOSR assessed by the patient using a Visual Analogue Scale (VAS). The VAS is a scale used to measure intensity of each symptom of the attack at baseline and at the pre-determined time points throughout treatment period. It consists of a horizontal 10cm line, with the 0 point corresponding to a state where patient experiences no symptoms at all and the 10cm point represents the worst symptoms ever experienced by patient. The patient indicates his/her current state of symptoms by drawing a mark across the horizontal line. TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the 3 primary symptoms: cutaneous swelling, cutaneous skin, and abdominal pain. The primary symptom was based on the type of attack. For abdominal attacks, the single primary symptom was abdominal pain. For cutaneous attacks, the single primary symptom was either skin swelling or skin pain, whichever was most severe.

Secondary outcomes

Time to Regression (Start of Improvement) According to Patient

Time frame · 5 days

This parameter assessed the time to regression (start of improvement) of observable(visible) symptoms according to the patients. Patients were asked "Report date and time when you feel that your symptoms start to improve".

Time to Almost Complete Symptom Relief

Time frame · 5 days

The time to almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least 3 consecutive measurements for all symptom.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Age above 18 years; * Documented diagnosis of HAE Type I or II (confirmed complement 1 esterase inhibitor \[C1-INH\] deficiency); * Current edema be in the cutaneous, abdominal and/or laryngeal areas; * Current edema be moderate to severe according to the investigator's Symptom Score. Exclusion Criteria: * Diagnosis of angioedema other than HAE, for example, acquired angioedema (AAE); * Participation in a clinical trial of another investigational medicinal product (IMP) within the past month; * Treatment with any pain medication since onset of the current edema attack; * Treatment with replacement therapy, including C1-INH products (e.g. human C1-INH preparations), less than 3 days from onset of the current edema attack; * Treatment with ACE inhibitors (e.g. Lotensin, Prinivil, Accupril); * Evidence of severe, symptomatic coronary artery disease based on medical history or screening examination; * Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial; * Pregnancy and/or breast-feeding.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Georgetown University Hospital, Lombardi Cancer Center

Washington D.C., District of Columbia, United States

Publications

Results and literature.

PMID 24749847 ↗Malbran A, Riedl M, Ritchie B, Smith WB, Yang W, Banerji A, Hebert J, Gleich GJ, Hurewitz D, Jacobson KW, Bernstein JA, Khan DA, Kirkpatrick CH, Resnick D, Li H, Fernandez Romero DS, Lumry W. Repeat treatment of acute hereditary angioedema attacks with open-label icatibant in the FAST-1 trial. Clin Exp Immunol. 2014 Aug;177(2):544-53. doi: 10.1111/cei.12358.PMID 20818888 ↗Cicardi M, Banerji A, Bracho F, Malbran A, Rosenkranz B, Riedl M, Bork K, Lumry W, Aberer W, Bier H, Bas M, Greve J, Hoffmann TK, Farkas H, Reshef A, Ritchie B, Yang W, Grabbe J, Kivity S, Kreuz W, Levy RJ, Luger T, Obtulowicz K, Schmid-Grendelmeier P, Bull C, Sitkauskiene B, Smith WB, Toubi E, Werner S, Anne S, Bjorkander J, Bouillet L, Cillari E, Hurewitz D, Jacobson KW, Katelaris CH, Maurer M, Merk H, Bernstein JA, Feighery C, Floccard B, Gleich G, Hebert J, Kaatz M, Keith P, Kirkpatrick CH, Langton D, Martin L, Pichler C, Resnick D, Wombolt D, Fernandez Romero DS, Zanichelli A, Arcoleo F, Knolle J, Kravec I, Dong L, Zimmermann J, Rosen K, Fan WT. Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema. N Engl J Med. 2010 Aug 5;363(6):532-41. doi: 10.1056/NEJMoa0906393.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

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