Table 1.
Clinical trials of IFN-α and their results.
| Identifier Number (Study Date) | Clinical Trial Title | Treatment Arms | Study Results | References | ||
|---|---|---|---|---|---|---|
| NCT02761629 (April 2005 – May 2008) | Randomized, Multi-Center, Phase IV, Comparative Study to Assess the Efficacy of Combined Peg-Interferon Alpha-2a (40 kD) with Ribavirin Combined Therapy for 48 or 72 weeks of Treatment and 24 weeks of Follow-Up in Patients with Chronic Hepatitis C, Genotype 1, Co-Infected with Human Immunodeficiency Virus | Participants received 180 micrograms (mcg) of Peg-IFN-Alpha-2A (once weekly, subcutaneous injection) and ribavirin [1000 milligrams (mg) or 1200 mg] for 48 weeks | Participants received 180 micrograms (mcg) of Peg-IFN-Alpha-2A (once weekly, subcutaneous injection) and ribavirin [1000 milligrams (mg) or 1200 mg] for 72 weeks | 1. 36.5% of participants experienced Sustained Virologic Response (SVR) with 72 weeks of treatment. 2. 56.9% of subjects have undetectable HCV RNA with 72 weeks of treatment. |
(34) | |
|
NCT00491244 (June 2007 - September 2013) |
Pegylated Interferon Alfa-2a Plus Low Dose Ribavirin Versus Pegylated Interferon Alfa-2a Alone for Treatment-naive Hemodialysis Patients with Chronic Hepatitis C | Participants received pegylated interferon alfa-2a 135 ug/week plus ribavirin 200 mg/day for 24 to 48 weeks | Participants received pegylated interferon alfa-2a 135 ug/week for 24 to 48 weeks | Significant difference (p < 0.001) in SVR between participants receiving peginterferon and ribavirin compared to peginterferon only | (35) | |
|
NCT01095835 (February 2005 - January 2010) |
A Multicenter, Randomized, Controlled Study Comparing the Efficacy and Safety of 48 weeks of 40 kD Branched Pegylated Interferon Alfa-2a (PEG-IFN, RO 25-8310) Versus 96 Weeks of PEG-IFN, Alone or in Combination with 100 mg Lamivudine for 48 Weeks in Patients with HBeAg-Negative Chronic Hepatitis B | Participants received 180 mcg PEG-IFN (once weekly, subcutaneously) for 48 weeks | Participants received 180 mcg PEG-IFN (once weekly, subcutaneously) for 48 weeks, followed by 135 mcg PEG-IFN (once weekly subcutaneously) for another 48 weeks | Participants received 180 mcg PEG-IFN (once weekly, subcutaneously) for 48 weeks, followed by 135 mcg PEG-IFN (once weekly subcutaneously) for another 48 weeks and Lamivudine (100 mg, daily, orally) from Week 0 to 48 | 1. 11.8% of participants achieved combined response at the end of the follow-up period with PEG-IFN alfa-2a SC 180 mcg/week for 48 weeks 2. 25% of participants achieved combined response at the end of the follow-up period with PEG-IFN alfa-2a SC 180 mcg/week for 48 weeks followed by 135 mcg/week from 49 to 96 weeks 3. 20% of participants achieved combined response at the end of the follow-up period with Lamivudine PO 100mg/week and PEG-IFN alfa-2a for 48 weeks followed by PEG-IFN alfa-2a SC 135 mcg/week from 49 to 96 weeks |
(36) |
|
NCT02263079 (June 16, 2014 – January 29, 2020) |
A Phase IIIb, Randomized, Open-Label Study of Pegylated Interferon Alfa-2A in Combination with Lamivudine or Entecavir Compared with Untreated Control Patients in Children with HBeAg Positive Chronic Hepatitis B in the Immune-Tolerant Phase | Participants received either Entecavir (film-coated tablet/oral solution, once daily, 0.015 mg/kg) or Lamivudine (film-coated tablet/oral, once daily, 3 mg/kg) for 8 weeks followed by peg-IFN-alfa-2A (180 mcg/1.73m2 body surface area, BSA) combined with either Entecavir or Lamivudine for 48 weeks | Untreated Control Participants (observed up to 80 weeks) | Participants received Peginterferon Alfa 2A (180 mcg/1.73m2 BSA, once weekly, subcutaneously) for 48 weeks | 3.8% of participants show eradication of HBsAg after 24 weeks of treatment compared to untreated control participants | (37) |
| NCT00594880 (January 2008 – May 2011) | Antiviral Activity of Peg-IFN-Alpha-2A in Chronic HIV-1 Infection | Participants received 180 mcg Peg-IFN-Alpha-2A (once weekly, subcutaneous) for 24 weeks; 5 weeks with ART, then 7 weeks without ART and further 12 weeks without ART | Participants received 90 mcg Peg-IFN-Alpha-2A (once weekly, subcutaneous) for 24 weeks; 5 weeks with ART, then 7 weeks without ART and further 12 weeks without ART | 1. Pegasys dose of 90 mcg/week has better outcome in suppression of HIV Viral Load than 180 mcg/week. 2. 12 weeks of 90mcg/week Pegasys treatment successfully reduced HIV Viral Load below 400 copies/ml in 50% of participants while 24 weeks of 90mcg/week Pegasys treatment successfully reduced HIV Viral Load below 400 copies/mL in 80% of participants. 3. 30% of participants had HIV Viral Load below 48 copies/ml in 12 weeks of 90mcg/week Pegasys treatment. |
(38) | |
| NCT00719264 (November 12, 2008 – April 15, 2013) | A Randomized, Open-Label, Multicenter Phase II Study to Compare Bevacizumab Plus RAD001 Versus Interferon Alfa-2a Plus Bevacizumab for the First-line Treatment of Patients with Metastatic Clear Cell Carcinoma of the Kidney | Participants received RAD001 (Everolimus, oral, 10 mg qd) plus Bevacizumab (10 mg/kg, intravenous, every 2 weeks) | Participants received interferon alfa-2a (3 million international unit, MIU, week 1; 6 MIU, week 2; 9 MIU, week 3 and subsequently, 3 times/week) plus Bevacizumab (10 mg/kg, intravenous, every 2 weeks) | 1. 9.3% of participants with Bevacizumab and Everolimus combination shows progression-free survival 2. 10% of participants with Interferon Alfa-2a and Bevacizumab combination shows progression-free survival 3. Combination of anti-cancer drugs with Interferon Alfa-2a have better efficacy in halting progression of tumor. |
(39) | |
| NCT00525031 (August 2006 – June 2016) | Randomized Phase II Neoadjuvant Study of Temozolomide Alone or with Pegylated Interferon-alpha 2b in Patients with Resectable American Joint Committee on Cancer (AJCC) Stage IIIB/IIIC or Stage IV (M1a) Metastatic Melanoma | Participants received Temozolomide (TMZ, 150 mg/m2 by mouth (once daily for 7 days, followed by 7 days off; alternating weekly) for 8 weeks | Participants received Temozolomide (150 mg/m2 by mouth (once daily for 7 days, followed by 7 days off; alternating weekly) for 8 weeks plus pegylated interferon alpha-2b (0.5 mcg/kg, subcutaneous injection, once weekly) for 8 weeks | 1. 15.4% of participants show positive clinical response toward tumor cell and 53.8% of participants show progression of tumor growth with Temozolomide (TMZ) PO 150 mg/m2/day for 8 weeks alternately (7 days treatment followed by 7 days off) 2. 29.2% of participants show positive clinical response toward tumor cell and 45.8% of participants show progression of tumor growth in combination of TMZ with PEG-IFN alfa-2b SC 0.5 mcg/kg/week for 8 weeks. |
(40) | |