ANZCTR - Registration

Reset your password and enable multi-factor authentication (MFA)

For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.

Go to the Login page, click ‘reset password’ and follow the instructions.
Check your email for the link to set a new password.
Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
Return to the Login page and enter your new password. A verification code will be sent to your email.
Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01290887

Registration number

NCT01290887

Ethics application status

Date submitted

4/02/2011

Date registered

7/02/2011

Date last updated

6/06/2016

Titles & IDs

Public title

Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma

Scientific title

An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients With Eosinophilic Asthma Who Completed a Prior Teva-Sponsored Study in Eosinophilic Asthma

Secondary ID [1]

2010-024540-15

Secondary ID [2]

C38072/3085

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Eosinophilic Asthma

Condition category

Condition code

Respiratory

Asthma

Respiratory

Other respiratory disorders / diseases

Blood

Haematological diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Drugs - Reslizumab

Experimental: Reslizumab 3.0 mg/kg - Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.

Treatment: Drugs: Reslizumab
Reslizumab (3.0 mg/kg) administered intravenously by infusion every 28 days (±7 days), for approximately 24 months

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Participants With Treatment-Emergent Adverse Events

Assessment method [1]

An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes.

Timepoint [1]

Day 1 (post-dose) to Week 65. The endpoint for adverse events was the last postbaseline observation, which included the 90 day follow-up visit.

Primary outcome [2]

Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Abnormal Lab Values

Assessment method [2]

Data represents participants with potentially clinically significant (PCS) abnormal serum chemistry, hematology, and urinalysis values on any of the during treatment lab analyses. Significance criteria: * Blood urea nitrogen: \>=10.71 mmol/L * Creatinine: \>=177 µmol/L * Uric acid: M\>=625, F\>=506 µmol/L * Aspartate aminotransferase: \>=3\*upper limit of normal (ULN). Normal range is 10-43 U/L * Alanine aminotransferase: \>=3\*ULN. Normal range is 10-40 U/L * GGT = gamma-glutamyl transpeptidase: \>= 3\*upper limit of normal. Normal range is 5-49 U/L. * Total bilirubin: \>=34.2 µmol/L * White blood cells- low: \<=3.0\*10\^9/L * White blood cells-high: \>=20\*10\^9/L * Hemoglobin: M\<=115, F\<=95 g/dL * Hematocrit: M\<0.37, F\<0.32 L/L * Platelets: \>=700\*10\^9/L * Absolute neutrophil count: \<=1.0\*10\^9/L * Eosinophils: \>=10 * Urinalysis: ketones, blood, glucose, and total protein: \>=2 unit increase from baseline

Timepoint [2]

Weeks 4, 8, 24 and 48

Primary outcome [3]

Participants With Treatment-Emergent Potentially Clinically Significant (PCS) Vital Signs Values

Assessment method [3]

Data represents participants with PCS vital sign values during any of the during treatment visits or the follow-up visit. Significance criteria * Sitting heart rate-high: \>100 and increase of \>= 30 beats/min (all ages) * Sitting heart rate-low: \<50 and decrease of \>=30 beats/min * Sitting systolic blood pressure (BP)-high: \>130 and increase of \>=30 mmHg (ages 12-17) * Systolic BP-low: \<90 and decrease of \>=30 mmHg (ages \>=18) * Systolic BP-high: \>160 and increase of \>=30 mmHg (ages \>=18) * Sitting diastolic BP-low: \<55 and decrease of \>=12 mmHg (ages 12-17) * Diastolic BP-high: \>85 and increase of \>=12 mmHg (ages 12-17) * Diastolic BP-low: \<50 and decrease of \>=12 mmHg (ages \>=18) * Diastolic BP-high: \>100 and increase of \>=12 mmHg (ages \>=18) * Respiration rate: \>20 and increase of \>=10 breaths/minute (ages 12-17) * Respiration rate: \>24 and increase of \>=10 breaths/minute (ages \>=18) * Body temperature-low: \<96.5° Fahrenheit (all ages) * Body temp-high: \>100.5° F (all ages)

Timepoint [3]

Week 4 to Week 65

Secondary outcome [1]

Forced Expiratory Volume In 1 Second (FEV1) at Weeks 4, 8, 12, 16, 24, 36, 48, 60, 72, 84, 96, End of Study and Endpoint

Assessment method [1]

FEV1 is a standard measurement of air movement in the lungs of patients with asthma obtained from pulmonary function tests. It is the volume of air expired in the first second of a forced expiration using a spirometer.

Timepoint [1]