Open Label Study to Assess Safety and Immunogenicity of Omalizumab Liquid Formulation.

This study has been completed.

Sponsor:

Collaborators:

Genentech

Tanox

Information provided by:

Novartis

ClinicalTrials.gov Identifier:

NCT00500539

First received: July 11, 2007

Last updated: May 31, 2011

Last verified: May 2011

History of Changes

Results First Received: November 17, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Asthma
Intervention:	Drug: omalizumab

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Omalizumab	The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.

Participant Flow for 2 periods

Period 1: Treatment Period (24 Weeks)

	Omalizumab
STARTED	155
COMPLETED	140
NOT COMPLETED	15
Adverse Event	4
Unsatisfactory therapeutic effect	1
Subject withdrew consent	1
Lost to Follow-up	2
Administrative problems	2
Protocol Deviation	5

Period 2: Follow-up Period (16 Weeks)

	Omalizumab
STARTED	148 ^[1]
COMPLETED	136
NOT COMPLETED	12
Adverse Event	1
Subject withdrew consent	2
Lost to Follow-up	3
Administrative problems	1
Death	1
Protocol Deviation	1
Missing	3

[1]	Participants could discontinue study drug and still enter the follow-up period.

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Omalizumab	The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.

Baseline Measures

	Omalizumab
Number of Participants [units: participants]	155
Age [units: participants]
<=18 years	13
Between 18 and 65 years	135
>=65 years	7
Age [units: years] Mean ± Standard Deviation	42.7 ± 14.32
Gender [units: participants]
Female	95
Male	60

Outcome Measures

Show All Outcome Measures

1. Primary:

The Number of Participants With Confirmed Positive Human Antihuman Antibody (HAHA) Results at the End of the 16-week Follow-up Period [ Time Frame: 16 weeks after last dose ]

Show Outcome Measure 1

2. Secondary:

Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment Period [ Time Frame: 24 weeks treatment period + 4 weeks for following up participants ]

Show Outcome Measure 2

3. Secondary:

Number of Participants Who Experienced Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Follow-up Period [ Time Frame: Last 12 weeks of the follow-up period (initial 4 weeks of the follow-up period were included in the treatment period for AE reporting) ]

Show Outcome Measure 3

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial; or the publication of the trial results in their entirety.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	external affairs, Novartis
ClinicalTrials.gov Identifier:	NCT00500539 History of Changes
Other Study ID Numbers:	CIGE025C2303
Study First Received:	July 11, 2007
Results First Received:	November 17, 2010
Last Updated:	May 31, 2011
Health Authority:	United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Germany: Paul-Ehrlich-Institut Spain: Spanish Agency of Medicines

To Top