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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interferon gamma 1b | Drug | Standard therapy vs dose titration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in severity of FLS vs baseline | 8 hrs post injection, thru 3 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Subject dropout rate | over 3 week study treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in severity of FLS vs baseline | At 4 & 12 hours post injection |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Matson, MD | Prism Research Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prism Research Inc | Saint Paul | Minnesota | 55114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21988668 | Background | 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. | |
| 24576196 | Derived |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 30, 2014 | |
| Unrelease | Yes | |
| Release | Jun 6, 2014 | |
| Reset | Jul 10, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 30, 2014 | Yes | |||
| Jun 6, 2014 |
| ID | Term |
|---|---|
| D007371 | Interferon-gamma |
| C554125 | interferon gamma-1b |
| ID | Term |
|---|---|
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| 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. |
| Jul 10, 2014 |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D016215 | Macrophage-Activating Factors |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |