NEWS HIGHLIGHTS
Published Studies Related to Actimmune (Interferon Gamma-1B)
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.
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.
Adjuvant interferon gamma in patients with pulmonary atypical Mycobacteriosis: a randomized, double-blind, placebo-controlled study. [2008.02.11]
BACKGROUND: High antibiotic resistance is described in atypical Mycobacteriosis, mainly by Mycobacterium avium complex (MAC)... CONCLUSION: These data suggest that IFN gamma is useful and well tolerated as adjuvant therapy in patients with pulmonary atypical Mycobacteriosis, predominantly MAC. Further wider clinical trials are encouraged. TRIAL REGISTRATION: Current Controlled Trials ISRCTN70900209.
Double-blind trial of recombinant gamma-interferon versus placebo in the treatment of rheumatoid arthritis. 1989. [2008.02]
One hundred five patients were enrolled in a 12-week, randomized, prospective, double-blind, placebo-controlled trial of recombinant human gamma-interferon (rHu gamma-IFN) for the treatment of rheumatoid arthritis.Although the improvement with rHu gamma-IFN was greater than that with placebo, the differences were generally not statistically significant.
Final results of a double-blind, placebo-controlled trial of the antifibrotic efficacy of interferon-gamma1b in chronic hepatitis C patients with advanced fibrosis or cirrhosis. [2007.03]
CONCLUSION: IFN-gamma1b therapy was not able to reverse fibrosis in patients with advanced liver disease for 1 year. Subgroups of patients with elevated ITAC levels and perhaps less advanced disease may be considered for future studies with IFN-gamma1b.
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.
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)
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.
Safety and Efficacy of Interferon Gamma-1b Plus Chemotherapy for Ovarian and Peritoneal Cancer [Terminated]
The purposes of this study are to determine: 1) if treatment with interferon gamma-1b plus
standard chemotherapy (carboplatin and paclitaxel) can increase the overall survival of
patients with advanced ovarian or primary peritoneal carcinoma compared with chemotherapy
alone; 2) how effective interferon gamma-1b plus standard chemotherapy is in preventing the
progression or return of cancer; 3) the effects on quality of life; and 4) the safety of
interferon gamma-1b combined with standard chemotherapy compared to chemotherapy alone.
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.
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