NEWS HIGHLIGHTS
Published Studies Related to Actimmune (Interferon Gamma-1B)
Low-dose recombinant canine interferon-gamma for treatment of canine atopic dermatitis: an open randomized comparative trial of two doses. [2010.02]
The purpose of this study was to investigate the minimum effective dose of recombinant canine interferon-gamma (rCaIFN-gamma) for the treatment of dogs with atopic dermatitis (AD). Thirty-four dogs with AD from 17 animal hospitals in Japan were administered half or one-fifth of the approved rCaIFN-gamma dose of 10 000 units/kg, three times a week for 4 weeks, followed by once weekly for an additional 4 weeks...
Immunomodulation with recombinant interferon-gamma1b in pulmonary tuberculosis. [2009.09.15]
CONCLUSION: Recombinant interferon-gamma1b adjuvant therapy plus DOTS in cavitary pulmonary tuberculosis can reduce inflammatory cytokines at the site of disease, improve clearance of Mtb from the sputum, and improve constitutional symptoms. TRIAL REGISTRATION: ClinicalTrials.gov NCT00201123.
Effect of interferon gamma-1b on survival in patients with idiopathic pulmonary fibrosis (INSPIRE): a multicentre, randomised, placebo-controlled trial. [2009.07.18]
BACKGROUND: Idiopathic pulmonary fibrosis is a fatal disease for which no effective treatment exists. We assessed whether treatment with interferon gamma-1b improved survival compared with placebo in patients with idiopathic pulmonary fibrosis and mild-to-moderate impairment of pulmonary function... INTERPRETATION: We cannot recommend treatment with interferon gamma-1b since the drug did not improve survival for patients with idiopathic pulmonary fibrosis, which refutes previous findings from subgroup analyses of survival in studies of patients with mild-to-moderate physiological impairment of pulmonary function. FUNDING: InterMune.
Endogenous blood maximal interferon-gamma production may predict response to interferon-gamma 1beta treatment in patients with idiopathic pulmonary fibrosis. [2009.07]
BACKGROUND: Idiopathic pulmonary fibrosis (IPF) is an untreatable lung disorder with a mean survival of 3 years after diagnosis. Treatment with interferon-gamma (IFN-gamma) 1beta has been reported to significantly improve lung function and arterial oxygen saturation in a first randomized controlled trial; unexpectedly, these findings have not been confirmed in a subsequent large placebo-controlled randomized study...
Randomized phase 3 trial of interferon gamma-1b plus standard carboplatin/paclitaxel versus carboplatin/paclitaxel alone for first-line treatment of advanced ovarian and primary peritoneal carcinomas: results from a prospectively designed analysis of progression-free survival. [2008.05]
OBJECTIVES: Interferon gamma (IFN-gamma) is a pleiotropic cytokine with antiproliferative, immunostimulatory, and chemosensitization properties. This trial was designed to evaluate IFN-gamma 1b plus carboplatin and paclitaxel in treatment-naive ovarian cancer (OC) and primary peritoneal carcinoma (PPC) patients... CONCLUSIONS: Treatment with IFN-gamma 1b in combination with carboplatin/paclitaxel does not have a role in the first-line treatment of advanced ovarian cancer.
Clinical Trials Related to Actimmune (Interferon Gamma-1B)
Topical Interferon Gamma-1b for Central Serous Chorioretinopathy [Completed]
Background:
- In the eye disease central serous chorioretinopathy (CSC), fluid collects under the retina
at the back of the eye. CSC can resolve on its own, but in some people it lasts for several
months or can come back. The fluid buildup during CSC can cause vision loss. The drug
interferon gamma-1b can help reduce fluid accumulation in the retina. Researchers want to
see if interferon gamma-1b can help treat and prevent vision loss from CSC.
Objectives:
- To see if interferon gamma-1b eye drops are a safe and effective treatment for CSC.
Eligibility:
- Individuals at least 18 years of age who have CSC in at least one eye.
Design:
- Participants will be screened with a physical exam and medical history. They will also
have an eye exam and blood tests.
- This study will require at least ten visits to the National Institutes of Health eye
clinic over a total of 52 weeks (one year). Most visits will last up to 4 hours.
- Participants will return to the eye clinic 2 days after the first visit and 1, 2, 4, 8,
12, 24, 36 and 48 weeks after starting the study eye drops. These visits will involve
blood tests and eye exams.
- Participants will receive the study eye drops at the initial visit. The drops must be
used three or four times a day for 2 weeks. They must be stored in a cool place (like a
refrigerator). The doses will follow an escalation schedule with the first participant
receiving 2 drops three times a day and the last participant receiving 4 drops four
times a day. To maximize safety, the most-recently enrolled participant will complete
Week 4 before the next participant can enroll (e. g., the second enrolled participant
will not be enrolled until the first has completed the Week 4 visit).
- If the CSC does not improve after the first 2 weeks, participants will receive another
2 weeks of eye drops. This set of drops will start 4 weeks after the initial study
visit.
- If the CSC does not improve after the 8-week study period, participants may receive
additional eye drops at the maximum dose of 4 drops four times daily.
- The study will end for each participant at one year (48 weeks after the initial study
visit).
Topical Interferon Gamma for Macular Edema Secondary to Uveitis [Completed]
Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers [Active, not recruiting]
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.
An Open-Label Study of the Safety of Interferon Gamma-1b in Patients With IPF [Terminated]
Open-label therapy will be administered to up to 220 patients, following completion of
either InterMune Protocol GIPF-002 Part B or Protocol GIPF-004, to assess the long-term
safety of subcutaneous Interferon gamma-1b. The study duration will be 5 years.
Interferon Gamma-1b Administered Topically for Macular Edema/Intraretinal Schisis Cysts in Rod-Cone Dystrophy (RCD) and Enhanced S-Cone Syndrome (ESCS) [Recruiting]
Background:
- People with rod-cone dystrophy (RCD) or enhanced S-cone syndrome (ESCS) have excess fluid
under the retina of their eye. This can cause vision loss. The medicine interferon gamma-1b
may help people with these diseases.
Objectives:
- To see if interferon gamma-1b eyedrops are safe for people with RCD or ESCS. To see if the
medicine can decrease retina fluid and help prevent vision loss.
Eligibility:
- People at least 12 years old with RCD or ESCS. Those with ESCS must have two mutations in
the NR2E3 gene.
Design:
- Participants will be screened with medical history, physical exam, eye exam, and blood
tests.
- Participants will stay at NIH for 2 days and get the first eyedrops.
- Participants will give themselves 4 study eyedrops 4 times daily for 2 weeks and keep a
diary.
- Participants will have 2 phone calls and 5 outpatient visits over 8 weeks. They may
have:
- Repeats of screening tests.
- Questionnaires.
- Small piece of skin removed.
- Eye exams, including eye dilation and tasks on computer screens.
- Fluorescein angiography. A dye injected into an arm vein will travel to the blood
vessels in the eyes. A camera will take pictures.
- Electroretinography. Participants will sit in the dark wearing eyepatches. A small
electrode will be taped to the forehead. After 30 minutes, researchers will remove the
eyepatches and put in numbing eyedrops and contact lenses. Participants will watch
flashing lights.
- Electrooculography. Electrodes will be attached outside of the eyes and eye function
will be measured in the dark and the light.
- Participants will have a follow-up visit after 52 weeks.
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