NCT00629824 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Antonucci G, Longo MA, Angeletti C, Vairo F, Oliva A, Comandini UV, Tocci G, Boumis E, Noto P, Solmone MC, Capobianchi MR, Girardi E
The effect of age on response to therapy with peginterferon alpha plus ribavirin in a cohort of patients with chronic HCV hepatitis including subjects older than 65 yr. Am J Gastroenterol. 2007 Jul;102(7):1383-91. Epub 2007 Mar 31.
Hiramatsu N, Oze T, Tsuda N, Kurashige N, Koga K, Toyama T, Yasumaru M, Kanto T, Takehara T, Kasahara A, Kato M, Yoshihara H, Katayama K, Hijioka T, Hagiwara H, Kubota S, Oshita M, Haruna Y, Mita E, Suzuki K, Ishibashi K, Hayashi N
Should aged patients with chronic hepatitis C be treated with interferon and ribavirin combination therapy? Hepatol Res. 2006 Jul;35(3):185-9. Epub 2006 May 4.
Honda T, Katano Y, Urano F, Murayama M, Hayashi K, Ishigami M, Nakano I, Yoshioka K, Toyoda H, Kumada T, Goto H
Efficacy of ribavirin plus interferon-alpha in patients aged >or=60 years with chronic hepatitis C. J Gastroenterol Hepatol. 2007 Jul;22(7):989-95.
Iwasaki Y, Ikeda H, Araki Y, Osawa T, Kita K, Ando M, Shimoe T, Takaguchi K, Hashimoto N, Kobatake T, Tomita M, Kawaguchi M, Kobashi H, Sakaguchi K, Shiratori Y
Limitation of combination therapy of interferon and ribavirin for older patients with chronic hepatitis C. Hepatology. 2006 Jan;43(1):54-63.
Thabut D, Le Calvez S, Thibault V, Massard J, Munteanu M, Di Martino V, Ratziu V, Poynard T
Hepatitis C in 6,865 patients 65 yr or older: a severe and neglected curable disease? Am J Gastroenterol. 2006 Jun;101(6):1260-7.

Efficacy and Safety of Pegylated Interferon Plus Ribavirin Combination Therapy in Treating Older Patients With Chronic Hepatitis C

Details for clinical trial NCT00629824

Clinical trial NCT00629824 - References