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Actimmune (Interferon Gamma-1B) - Summary

 


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ACTIMMUNE SUMMARY

ACTIMMUNE ® (Interferon gamma-1b), a biologic response modifier, is a single-chain polypeptide containing 140 amino acids.

ACTIMMUNE is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease.

ACTIMMUNE is indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis.


See all Actimmune indications & dosage >>

ACTIMMUNE NEWS HIGHLIGHTS

Media Articles Related to Actimmune (Interferon Gamma-1B)

Survival Of Patients With Idiopathic Pulmonary Fibrosis (IPF) Does Not Improve With Interferon Gamma-1b Treatment
Source: Respiratory / Asthma News From Medical News Today [2009.06.30]
An article published Online First and in an upcoming edition of The Lancet reports the findings of the INSPIRE trial on treatment of idiopathic pulmonary fibrosis (IPF) with interferon gamma-1b (Ifn-g1b). It is written by Professor Talmadge E King Jr, of the University of California, San Francisco (UCSF), USA and his team. Results show no improvement in survival compared with placebo. There is no effective treatment for IPF which is a fatal disease.

No Benefit in IPF from Interferon Gamma-1b (CME/CE)
Source: MedPage Today Pulmonary [2009.06.30]
RIDGEWOOD, N.J. (MedPage Today) -- Treatment with interferon gamma-1b did not improve survival among patients with mild-to-moderate idiopathic pulmonary fibrosis in a large multicenter study.

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Published Studies Related to Actimmune (Interferon Gamma-1B)

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.

A randomized comparative clinical trial of recombinant canine interferon-gamma (KT-100) in atopic dogs using antihistamine as control. [2006.06]
Recombinant canine interferon-gamma (KT-100) or topical antihistamine (diphenhydramine: DH) was administered to dogs with atopic dermatitis (AD) for 4 weeks and their efficacies were compared using pruritus, excoriation, erythema and alopecia as evaluation criteria. Clinical studies on 92 atopic dogs (KT-100 group: 63, DH group: 29) were conducted at 18 animal hospitals in Japan...

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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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Page last updated: 2009-06-30

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