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)
Post Marketing Surveillance Study of Actimmune in Patients With Severe, Malignant Osteopetrosis [Completed]
The purpose of this study is to establish a registry of all children with severe, malignant
osteopetrosis who are treated with Actimmune (IFN-g 1b or Interferon gamma-1b) to monitor the
effects of IFN-g 1b on preventing progression of this disease and to follow the safety of
patients receiving it on a long-term basis. In addition, evaluation of the possible effect
of Actimmune therapy on the humoral response to normal childhood vaccinations in this same
patient population will be examined. Interferon gamma is a substance that the body makes
naturally.
A Phase II Study to Determine the Safety and Efficacy of Interferon-Gamma in Patients With Chronic Hepatitis B [Not yet recruiting]
Open-label, prospective, two part study evaluating IFN-γ 1b at a dose of 200μg by
subcutaneous injection every day either alone or in combination with Adefovir dipivoxil or
Adefovir dipivoxil alone at a dose of 10mg QD in patients with chronic Hepatitis B.
A Pilot Study of Aerosol Interferon-Gamma for Treatment of Idiopathic Pulmonary Fibrosis [Recruiting]
Idiopathic pulmonary fibrosis (IPF) is a progressive disease for which there is no effective
treatment. Interferon-gamma is a medication that has been used for other lung diseases to
decrease scarring and fibrosis. Studies of interferon-gamma injected under the skin did not
show any improvement in survival in patients with IPF. We hypothesize that giving
interferon-gamma as a nebulized mist directly into the lungs can affect the immune system in
a way that decreases fibrosis.
Topical Interferon Gamma for Macular Edema Caused by Uveitis [Recruiting]
Background:
- Uveitis is a serious eye condition in which the immune system attacks the eye and can
cause vision loss. A common problem related to uveitis is macular edema. This is a
swelling of the central part of the retina. This part of the retina is needed for
sharp, clear vision. This swelling can lead to more vision loss.
- Interferon gamma-1b is a lab-created protein that acts like the material made by the
white blood cells that help fight infection. It changes the way the immune system
reacts to the cells in the eye and may help to lessen the swelling in the back of the
eye. It has been used as an injection to treat other immune diseases, but it has not
been tested as an eye drop for use in uveitis other than a safety trial done at NIH in
2010.
Objectives:
- To test the effectiveness of interferon gamma eye drops to treat macular edema caused by
uveitis.
Eligibility:
- Individuals at least 18 years of age who have autoimmune uveitis in one or both eyes, have
had it for at least 3 months, and as a result have macular edema in at least one eye.
Design:
- This study requires three visits to the study clinic over about 2 weeks. Each visit
will last 1 to 2 hours.
- Participants will be screened with a physical exam, medical history, and a full eye
exam. One eye will be designated as the study eye.
- Participants will place eye drops in the study eye four times a day for 1 week.
- At the second study visit (after 1 week), participants will have an eye exam and a
physical exam, and will return the eye drops.
- Participants will have a final study visit 1 week after the second visit, with a final
eye exam.
The INSPIRE Trial: A Study of Interferon Gamma-1b for Idiopathic Pulmonary Fibrosis (IPF) [Terminated]
- Purpose: A phase 3, randomized, double-blind, placebo-controlled trial to determine the
efficacy and safety of 200 µg of recombinant Interferon gamma-1b administered by
subcutaneous (SC) injection, compared with placebo, in patients with IPF
- Enrollment: Approximately 800 patients will be enrolled from approximately 80 centers in
North America and Europe
- Randomization: 2: 1 active-to-placebo ratio
- Duration: at least 2 years active drug or placebo (rescue therapy will be permitted for
patients who meet predefined criteria)
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