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

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ClinicalTrials.gov Identifier: NCT01929382
Recruitment Status : Unknown
Verified August 2013 by Vidara Therapeutics Research Ltd.
Recruitment status was:  Active, not recruiting
First Posted : August 27, 2013
Last Update Posted : August 28, 2013
Sponsor:
Information provided by (Responsible Party):
Vidara Therapeutics Research Ltd

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Adverse Effects in the Therapeutic Use of Interferon Drug: interferon gamma 1b Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : July 2013
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu

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 Name: 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 Name: Actimmune




Primary Outcome Measures :
  1. Change in severity of FLS vs baseline [ Time Frame: 8 hrs post injection, thru 3 weeks of treatment ]

Secondary Outcome Measures :
  1. Subject dropout rate [ Time Frame: over 3 week study treatment ]

Other Outcome Measures:
  1. Change in severity of FLS vs baseline [ Time Frame: At 4 & 12 hours post injection ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929382


Locations
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United States, Minnesota
Prism Research Inc
St. Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Vidara Therapeutics Research Ltd
Investigators
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Principal Investigator: Mark Matson, MD Prism Research Inc
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Vidara Therapeutics Research Ltd
ClinicalTrials.gov Identifier: NCT01929382    
Other Study ID Numbers: VTRL Clin 2013-001
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013
Keywords provided by Vidara Therapeutics Research Ltd:
dose titration
FLS
flu like symptoms
Actimmune
Additional relevant MeSH terms:
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Interferons
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents