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Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair Dosing (X-PAND)

2017年6月8日更新者：Genentech, Inc.

Pharmacosurveillance Data Repository of Patients With and Without History of Anaphylactic Reactions Subsequent to Xolair(R) Dosing

This study will establish a clinical data and serum repository of anaphylaxis cases associated with Xolair administration and control patients who have received Xolair without associated anaphylaxis. This is an observational repository and not an investigational clinical trial. Associated with the repository is an optional skin testing substudy.

調査の概要

状態

完了

条件

アレルギー性喘息

介入・治療

薬：Xolair

研究の種類

観察的

入学 (実際)

118

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

アメリカ
- California
  - Los Angeles、California、アメリカ、90025
    - Investigational Site
- Florida
  - Valrico、Florida、アメリカ、33596
    - Investigational Site
- Illinois
  - Hinsdale、Illinois、アメリカ、60521
    - Investigational Site
- Missouri
  - Kansas City、Missouri、アメリカ、64111
    - Investigational Site
- New York
  - New York、New York、アメリカ、10022
    - Investigational Site
- Pennsylvania
  - Blue Bell、Pennsylvania、アメリカ、19422
    - Investigational Site
- Texas
  - San Antonio、Texas、アメリカ、78229
    - Investigational Site

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

子
大人
高齢者

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

primary care clinic

説明

Inclusion Criteria for Cases:

Confirmed anaphylaxis based on Sampson criteria subsequent to Xolair

Inclusion Criteria for Controls:

At least 1 patient control among 4 controls who discontinued Xolair for at least 16 weeks but not more than 18 months at enrollment
At least one dose of Xolair in the 18 months before the date of the case event (index date)
No prior anaphylaxis or other hypersensitivity reaction subsequent to Xolair dosing, including any reactions to its components

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Number of Participants With Clinical Signs and Symptoms of Adjudicated Anaphylaxis Events - Case Participants 時間枠：Baseline (Enrollment Visit)	Clinical signs and symptoms of adjudicated anaphylaxis events included: Cutaneous/Subcutaneous/Mucosal, Respiratory (R), Cardiovascular (CV), and Gastrointestinal (GIT) signs and symptoms.	Baseline (Enrollment Visit)
Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants 時間枠：Baseline (Enrollment Visit)		Baseline (Enrollment Visit)
Categorical Time From Last Omalizumab Dose to Adjudicated Anaphylactic Symptoms - Case Participants 時間枠：Baseline (Enrollment Visit)	Time from last omalizumab dose to adjudicated anaphylactic symptoms was classified as: less than (<) 30 minutes, 30-60 minutes, greater than (>) 60-90 minutes, >90-120 minutes, >120 minutes to 360 minutes, and missing. Number of participants in each time category is reported.	Baseline (Enrollment Visit)
Total Omalizumab Doses Received When Adjudicated Anaphylactic Event Occurred - Case Participants 時間枠：Baseline (Enrollment Visit)	Omalizumab doses were classified as: 1 dose, 2 doses, 3 doses, 4-20 doses, 21-40 doses, 41-60 doses, >60 doses, and missing. Number of participants in each dose category is reported.	Baseline (Enrollment Visit)
Treatment Received Following Adjudicated Anaphylactic Event - Case Participants 時間枠：Baseline (Enrollment Visit)	Treatment received following adjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.	Baseline (Enrollment Visit)
Outcome Attributed to Adjudicated Anaphylactic Event - Case Participants 時間枠：Baseline (Enrollment Visit)	Outcomes of adjudicated anaphylactic event were classified as: death, life-threatening, required in-patient hospitalization or its prolongation, disabling, congenital anomaly/birth defect in offspring of participant, and other (outcome did not meet any of the above criteria, but may jeopardize the participant, and may require medical or surgical intervention to prevent one of the outcomes listed above). Number of participants in each outcome category is reported. Only outcomes with results are reported.	Baseline (Enrollment Visit)
Number of Participants Reinitiating Omalizumab After Adjudicated Anaphylactic Event - Case Participants 時間枠：Baseline (Enrollment Visit)		Baseline (Enrollment Visit)
Number of Participants With Prior Unadjudicated Anaphylactic Events - Case Participants 時間枠：Baseline (Enrollment Visit)		Baseline (Enrollment Visit)
Treatment Following Prior Unadjudicated Anaphylactic Events - Case Participants 時間枠：Baseline (Enrollment Visit)	Treatment received following prior unadjudicated anaphylactic events was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.	Baseline (Enrollment Visit)
Number of Participants With Subsequent Unadjudicated Anaphylactic Events - Case Participants 時間枠：Baseline (Enrollment Visit)		Baseline (Enrollment Visit)
Treatment Following Subsequent Unadjudicated Anaphylactic Events - Case Participants 時間枠：Baseline (Enrollment Visit)	Treatment received following subsequent unadjudicated anaphylactic event was classified as: antihistamine, epinephrine, inhaled beta agonists, systemic corticosteroids, and other. Number of participants in each treatment category is reported. Participants could have received more than 1 treatment.	Baseline (Enrollment Visit)
Medications Received Within Two Weeks Prior to the Adjudicated Anaphylactic Event - Case Participants 時間枠：Baseline (Enrollment Visit)	Number of participants in each medication class is reported. Participants could have received more than 1 medication class. NEC: Not Elsewhere Classified.	Baseline (Enrollment Visit)
Medications Within Two Weeks Prior to Blood Draw 時間枠：Baseline (Enrollment Visit)	Number of participants in each medication class is reported. Participants could have received more than 1 medication class.	Baseline (Enrollment Visit)
Number of Participants With Anti-Therapeutic Antibodies (ATA) - Main Study 時間枠：Baseline (Enrollment Visit)	Participants with positive immunoglobulin G (IgG) ATA, negative IgG ATA, positive immunoglobulin E (IgE) ATA, and negative IgE ATA are reported.	Baseline (Enrollment Visit)
Number of Participants With Positive Skin Reaction After Skin Prick Test - Skin Testing Substudy 時間枠：Substudy Day 1		Substudy Day 1
Number of Participants With ATA - Skin Testing Substudy 時間枠：Substudy Week 10	Participants with positive IgG ATA, negative IgG ATA, positive IgE ATA, and negative IgE ATA are reported.	Substudy Week 10

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Genentech, Inc.

捜査官

スタディディレクター：Abdelkader Rahmaoui, M.D.、Genentech, Inc.

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2009年3月1日

一次修了 (実際)

2014年1月1日

研究の完了 (実際)

2014年1月1日

試験登録日

最初に提出

2008年12月22日

QC基準を満たした最初の提出物