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A Study of Avonex® to Determine the Effects of Dose Titration on the Incidence of Flu Like Symptoms in Healthy Volunteers

Information source: Biogen
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: Avonex (Drug)

Phase: N/A

Status: Completed

Sponsored by: Biogen

Summary

This is a randomized, 3-arm, dose-blinded, parallel-group study. Subjects will be randomized to one of 3 treatment titration regimes (slow titration over 6 weeks, fast titration over 3 weeks, and no titration).

Clinical Details

Official title: A Randomized, Three-Arm, Dose-Blinded, Parallel-Group Study to Determine the Effect of Avonex Dose Titration on the Severity and Incidence of Interferon Beta-1a-Related Flu Like Symptoms in Healthy Volunteers

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome: To determine whether titration of Avonex reduces the incidence of flu like symptoms

Secondary outcome: To evaluate the overall safety and tolerability of Avonex IM injections

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Must be healthy males or females aged 18 to 55 years old at the time of informed

consent.

- Must have a Body Mass Index of 19 to 30 kg/m2, and a minimum body weight of 50. 0 kg

at Screening.

- Female subjects of childbearing potential must practice effective contraception

during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. Exclusion Criteria:

- Known history of or positive test result for human immunodeficiency virus (HIV),

hepatitis C virus (test for hepatitis C virus antibody [HCV Ab]) or hepatitis B virus (test for hepatitis B surface antigen [HBsAg] and hepatitis B core antibody [HBcAb])

- Known history of chronic fatigue syndrome or fibromyalgia

- Within one month, flu-like illnesses (e. g., gastroenteritis, upper respiratory

infection, common cold)

- History of severe allergic reactions to any drug or anaphylactic reactions

- Known allergy to Avonex or any of its components

- Serious infection (e. g., pneumonia, septicemia) within the 3 months prior to

Screening or active bacterial or viral infection

- History of alcohol or substance abuse (as defined by the Investigator)

- Female subjects who are pregnant or currently breastfeeding

- Any previous treatment with any interferon product. 10. Vaccinations within 2 weeks or

5 half-lives, whichever is longer, prior to Day 1

- Blood donation within 30 days prior to Screening

- Use of any tobacco product more than 5 times within 30 days prior to Screening

Locations and Contacts

Research Site, St. Paul, Minnesota, United States
Additional Information

Starting date: May 2010
Last updated: April 14, 2011

Page last updated: August 20, 2015

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