NCT01929382

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 27, 2013

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 28, 2013

Status Verified

August 1, 2013

Enrollment Period

2 months

First QC Date

August 22, 2013

Last Update Submit

August 26, 2013

Conditions

Adverse Effects in the Therapeutic Use of Interferon

Keywords

dose titrationFLSflu like symptomsActimmune

Outcome Measures

Primary Outcomes (1)

  • Change in severity of FLS vs baseline

    8 hrs post injection, thru 3 weeks of treatment

Secondary Outcomes (1)

  • Subject dropout rate

    over 3 week study treatment

Other Outcomes (1)

  • Change in severity of FLS vs baseline

    At 4 & 12 hours post injection

Study Arms (2)

Actimmune (interferon gamma 1b)

ACTIVE COMPARATOR

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

Actimmune(interferon gamma 1b) titration

EXPERIMENTAL

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

Interventions

interferon gamma 1bDRUG

Standard therapy vs dose titration

Also known as: Actimmune
Actimmune (interferon gamma 1b)Actimmune(interferon gamma 1b) titration

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prism Research Inc

Saint Paul, Minnesota, 55114, United States

Location

Related Publications (2)

  • Matson MA, Zimmerman TR Jr, Tuccillo D, Tang Y, Deykin A. Dose titration of intramuscular interferon beta-1a reduces the severity and incidence of flu-like symptoms during treatment initiation. Curr Med Res Opin. 2011 Dec;27(12):2271-8. doi: 10.1185/03007995.2011.630720. Epub 2011 Oct 28.

    PMID: 21988668BACKGROUND

  • Devane JG, Martin ML, Matson MA. A short 2 week dose titration regimen reduces the severity of flu-like symptoms with initial interferon gamma-1b treatment. Curr Med Res Opin. 2014 Jun;30(6):1179-87. doi: 10.1185/03007995.2014.899209. Epub 2014 Mar 13.

    PMID: 24576196DERIVED

MeSH Terms

Interventions

Interferon-gammainterferon gamma-1b

Intervention Hierarchy (Ancestors)

InterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsMacrophage-Activating FactorsLymphokinesProteinsBiological Factors

Study Officials

  • Mark Matson, MD

    Prism Research Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2013

First Posted

August 27, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

August 28, 2013

Record last verified: 2013-08

Locations

US(1)