Interferon alpha-n1(Interferon alpha-n1) - 药物靶点：IFNAR_专利_临床

概要

基本信息

药物类型

干扰素

别名

Wellferon

靶点

IFNAR

作用机制

IFNAR激动剂(干扰素α/β受体复合体激动剂)、免疫调节剂、先天性抗病毒免疫应答诱导剂

治疗领域

感染消化系统疾病

在研适应症-

非在研适应症

慢性丙型肝炎

原研机构

Glaxo Wellcome, Inc.

在研机构-

非在研机构

Glaxo Wellcome SA

最高研发阶段撤市

首次获批日期

美国 (1999-03-25),

慢性丙型肝炎

最高研发阶段(中国)-

特殊审评-

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关联

2

项与 Interferon alpha-n1 相关的临床试验

NCT00002086 / Completed临床2期

A Randomized Trial to Evaluate the Safety and Efficacy of Combination Therapy With Retrovir ( AZT ) and HIVID ( ddC ) Versus Retrovir, HIVID, and Wellferon ( Interferon Alfa-n1 ) for the Treatment of HIV Infection

Primary: To determine whether the combination of zidovudine/zalcitabine/interferon alfa-n1 (Retrovir/HIVID/Wellferon) can produce complete responses (i.e., CD4 counts return to >= 800 cells/mm3 for more than 24 weeks) in patients with virus sensitive to all three agents. To determine the antiviral effect of the combination therapies as evidenced by measures of quantitative viral load performed at select study centers only.
Secondary: To determine the effectiveness of Retrovir/HIVID and Retrovir/HIVID/Wellferon in maintaining or increasing CD4 counts and preventing disease progression as evidenced by the development of an AIDS-defining indicator disease. To determine the effect of these regimens on secondary measures of clinical status (e.g., performance score, weight change, and secondary infections) and on measures of virologic activity such as serum p24 antigen. To assess the safety and tolerance of these regimens.

开始日期-

申办/合作机构

Glaxo Wellcome SA

JPRN-UMIN000002466 / Completed临床2期IIT

Multi-Center Phase II Clinical Trial on Efficacy and Safety of Interferon Alfa-n1 + Sorafenib Combination Therapy in Renal Cell Carcinoma - Phase II of Interferon Alfa-n1 + Sorafenib in Renal Cell Carcinoma

开始日期2009-09-01

申办/合作机构-

100 项与 Interferon alpha-n1 相关的临床结果

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100 项与 Interferon alpha-n1 相关的转化医学

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100 项与 Interferon alpha-n1 相关的专利（医药）

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62

项与 Interferon alpha-n1 相关的文献（医药）

2012-03-01·Journal of Interferon & Cytokine Research4区 · 医学

Recombinant and Natural Human Interferons: Analysis of the Incidence and Clinical Impact of Neutralizing Antibodies

4区 · 医学

Review

作者: Strayer, David R. ; Carter, William A.

This review summarizes and analyzes the clinical outcomes following treatment of a wide range of diseases with recombinant interferons (r-IFNs) and/or natural interferons (n-IFNs). The investigation focuses on the frequency of neutralizing antibodies (NABs) directed against IFN, which are formed during treatment and their clinical impact. r-IFNs (α-2a, α-2b, β-1a, and β-1b) induced seroconversion with generation of NABs in 17.2% of patients studied. The highest incidence of NABs occurred in macular degeneration (61.4%) with the lowest in multiple sclerosis (14.7%). The incidence of antibodies induced against n-IFNs was very low (<0.2%) and was significantly less than that seen for r-IFNs (P<0.0001). Overall, the fraction of relapsed and refractory patients is statistically greater in NAB positive patients compared to NAB negative patients (<0.0001), whereas the percentage of responding patients is higher in the NAB negative cohort (P<0.001). Finally, we also analyzed relapsed and refractory NAB positive patients who switched treatment to n-IFN, such as leukocyte derived Alferon N Injection® (α-n3) or Wellferon® (α-n1). Overall, in 33/40 (82%) of these relapsed or refractory patients, switching to n-IFNs restored the clinical response. This result is consistent with serology studies showing that the NABs directed against r-IFNs do not effectively cross-react with n-IFNs.

2006-02-01·Antiviral Therapy4区 · 医学

A Randomized, Placebo-Controlled Trial of Thymosin-α1 and Lymphoblastoid Interferon for Hbeag-Positive Chronic Hepatitis B

4区 · 医学

Article

作者: Ishaque, Shamsuddin Mohammed ; Lim, Seng Gee ; Wu, Ying Juan ; Sutedja, Dede Selamat ; Fock, Kwong Ming ; Koay, Evelyn ; Locarnini, Steven ; Suresh, Shirley ; Lim, Chee Chian ; Dan, Yock Young ; Machin, David ; Wai, Chun-Tao ; Lee, Yin Mei ; Bowden, Scott ; Wee, Aileen

Combination therapy between two immunomodulators used for treatment of chronic hepatitis B was explored based on reported therapeutic efficacy of interferon-α, and thymosin-α1 as monotherapeutic agents to determine if combination therapy was superior to interferon alone. This double-blinded, randomized, placebo-controlled trial compares the addition of thymosin-α1, 1.6 μg taken three times per week (combination therapy) or thymosin placebo (monotherapy) to lymphoblastoid interferon (Wellferon®), 5 million international units (MIU) taken three times per week, for 24 weeks. Entry criteria included positive hepatitis B e antigen (HBeAg); alanine aminotransferease (ALT) ≥1.5x upper normal limit, but ≤10xupper normal limit; positive HBV DNA; absence of cirrhosis; treatment naivety and no co-morbid factors. A total of 98 HBeAg-positive patients were recruited, of which 48 were randomized to combination therapy and 50 to monotherapy. The primary endpoint was the loss of HBeAg at 72 weeks. The secondary endpoints were HBeAg seroconversion, normalization of ALT, loss of HBV DNA and improvement in histology. The HBeAg loss was 45.8% and 28.0% for combination therapy and monotherapy, respectively (difference, 17.8%; 95% CI -1.2%-35.3%, P=0.067). There was a trend towards HBeAg loss when using combination therapy. There were also no statistically significant differences between the different therapies with respect to the secondary endpoints of HBeAg seroconversion, changes in histology, normalization of ALT or loss of HBV DNA. In conclusion, this trial showed a 17.8% improvement in HBeAg loss rates using combination therapy over interferon monotherapy. This could clinically indicate a potential important difference that would need confirmation in subsequent trials.

2003-01-01·Cancer Investigation4区 · 医学

Lymphoblastoid Alpha-interferon In The Prevention Of Hepatocellular Carcinoma (Hcc) In High-risk Hbsag-positive Resected Cirrhotic Hcc Cases: A 14-Year Follow-up

4区 · 医学

Article

作者: Wei Ning Chen ; Chong Jin Oon

Hepatocellular carcinoma (HCC) is a leading cause of death worldwide. It is also a common long-term complication of chronic hepatitis B or C infections, with cirrhosis as a risk factor for premalignant development. Natural lymphoblastoid alpha-interferon (alpha N1-IFN) has been widely used in treating chronic HBV and HCV carriers. To investigate its long-term beneficial effect in reducing the development of HCC, 20 hepatitis B surface antigen (HBsAg) positive resected cirrhotic HCC patients who have undergone chemotherapy followed by long-term treatment of 3MU alpha N1-IFN daily for 10 days every 3 months were analyzed in a 14 year follow-up. Results indicated that these patients survived and remained free of HCC. In contrast, 10 other patients receiving chemotherapy alone after resection eventually had HCC recur. Similar recurrence of HCC was seen in patients who had either reduced dosage of alpha N1-IFN or stopped interferon therapy or received 30MU dose at 6-month intervals. Our findings indicate the therapeutic potential and long-term safety of alpha N1-IFN in suppressing the development of HCC in high-risk patients.

100 项与 Interferon alpha-n1 相关的药物交易

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