Adverse Effects in the Therapeutic Use of InterferonPhase 1FLSNCT01929382
Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers
A Phase 1 study testing interferon gamma 1b in people with Adverse Effects in the Therapeutic Use of Interferon, run by Vidara Therapeutics Research Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Effects in the Therapeutic Use of Interferon
- What is being tested?
- interferon gamma 1b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
- Ability to understand purpose \& risks
- BMI 18-32kg/m2
- Females on contraception
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- interferon gamma 1b
- Keywords
- dose titration, FLS, flu like symptoms, Actimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon gamma 1bDrug
Also called Actimmune
Standard therapy vs dose titration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: interferon gamma 1b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of FLS vs baseline
Measured: 8 hrs post injection, thru 3 weeks of treatment
Secondary outcomes (1)
Subject dropout rate
Measured: over 3 week study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adverse Effects in the Therapeutic Use of InterferonStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vidara Therapeutics Research Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Matson, MD, Principal investigator, Prism Research Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929382
- Sponsor's protocol ID
- VTRL Clin 2013-001
- Acronym
- FLS
- Status last verified
- Aug 2013
- First submitted
- 22 Aug 2013
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21988668Devane 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.
PubMed 24576196
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01929382
- Acronym / sponsor ID
- FLS / VTRL Clin 2013-001
- Keywords
- dose titration, FLS, flu like symptoms, Actimmune
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Vidara Therapeutics Research LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Actimmune (interferon gamma 1b) | Active comparator | Drug: interferon gamma 1bSubjects > 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 | Drug: interferon gamma 1b30% 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy volunteers
- Ability to understand purpose \& risks
- BMI 18-32kg/m2
- Females on contraception
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interferon gamma 1bAlso: ActimmuneStandard therapy vs dose titration | Drug | Actimmune (interferon gamma 1b), Actimmune(interferon gamma 1b) titration |
Primary outcome
Change in severity of FLS vs baseline
Time frame: 8 hrs post injection, thru 3 weeks of treatment
1 secondary outcome
Subject dropout rate
Time frame: over 3 week study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
- Background: PubMed 21988668Matson 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.
- Derived from this study: PubMed 24576196Devane 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Matson, MD principal investigator
Prism Research Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing interferon gamma 1b in people with Adverse Effects in the Therapeutic Use of Interferon, run by Vidara Therapeutics Research Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of FLS vs baseline (time frame: 8 hrs post injection, thru 3 weeks of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01929382, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2013.