Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers (FLS)

August 26, 2013 updated by: Vidara Therapeutics Research Ltd

A Randomized, Double-Blind, Crossover Study to Determine the Effect of Actimmune® Dose Titration on the Severity and Incidence of Interferon Gamma-1b-Related Flu-Like Symptoms and the Pattern of Dropouts in Healthy Volunteers

The most frequent side effects associated with Actimmune (interferon gamma 1b) therapy are the occurrence of 'flu-like symptoms' (FLS),which might include fever, chills, muscle aches, and tiredness. Earlier studies have demonstrated that these symptoms are common in healthy volunteers as well as in patients.

This study is designed to determine whether a titration of dosing reduces the frequency and severity of the FLS. A reported study with another interferon (interferon beta), demonstrated a reduction in the frequency and severity of the FLS when a titration of dosing was used. This study will compare the effects of the standard dose regimen with a titration regimen in healthy volunteers.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • St. Paul, Minnesota, United States, 55114
        • Prism Research Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy volunteers
  • Ability to understand purpose & risks
  • BMI 18-32kg/m2
  • Females on contraception

Exclusion Criteria:

  • History of HIV,or pos test for HCV Ab,or HBsAg
  • History of chronic fatigue syndrome or fibromyalgia
  • Flu like illness within 1 month of start
  • History of depression or other mood disorder
  • History of malignant or pre-malignant disease
  • History of severe allergic reactions
  • Known allergy to Actimmune or its components
  • History of major diseases
  • Clinically Significant abnormal labs
  • Pregnant or breastfeeding
  • Clinically abnormal ECG
  • History of alcohol or substance abuse
  • Other study participation in last 4 weeks
  • Serious infection within 3 months
  • Use of Rx products within 4 weeks except contraceptives or dermatology products
  • Vaccinations within 2 weeks
  • Tobacco products ( with limitations)
  • Cant/wont comply with study requirements
  • Allergy shots within 1 month
  • Blood donation with limitations
  • Investigator discretion as to unsuitability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Actimmune (interferon gamma 1b)
Subjects > 0.5m2 BSA will receive 50 mcg/m2 BSA and subjects ≤ 0.5m2 BSA will receive 1.5mcg/kg/dose, as SC injections three times weekly, from week 1 to week 3.
Drug: interferon gamma 1b
Standard therapy vs dose titration
Other Names:
  • Actimmune
Experimental: Actimmune(interferon gamma 1b) titration
30% of the recommended dose as SC injections three times weekly in week 1, 60% the recommended dose as SC injections three times weekly in week 2, and at the recommended dose as SC injections three times weekly in week 3
Drug: interferon gamma 1b
Standard therapy vs dose titration
Other Names:
  • Actimmune

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in severity of FLS vs baseline
Time Frame: 8 hrs post injection, thru 3 weeks of treatment
8 hrs post injection, thru 3 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Subject dropout rate
Time Frame: over 3 week study treatment
over 3 week study treatment

Other Outcome Measures

Outcome Measure
Time Frame
Change in severity of FLS vs baseline
Time Frame: At 4 & 12 hours post injection
At 4 & 12 hours post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vidara Therapeutics Research Ltd

Investigators

  • Principal Investigator: Mark Matson, MD, Prism Research Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

August 22, 2013

First Submitted That Met QC Criteria

August 22, 2013

First Posted (Estimate)

August 27, 2013

Study Record Updates

Last Update Posted (Estimate)

August 28, 2013

Last Update Submitted That Met QC Criteria

August 26, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTRL Clin 2013-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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