Thymosin alpha1 treatment of chronic hepatitis B: results of a phase III multicentre, randomized, double-blind and placebo-controlled study. Journal of viral hepatitis. [J Viral Hepat] Journal article | | Title | Thymosin alpha1 treatment of chronic hepatitis B: results of a phase III multicentre, randomized, double-blind and placebo-controlled study. | | Author(s) | Mutchnick MG, Lindsay KL, Schiff ER, Cummings GD, Appelman HD, Peleman RR, Silva M, Roach KC, Simmons F, Milstein S, Gordon SC, Ehrinpreis MN | | Institution | Division of Gastroenterology, Department of Medicine, Wayne State University School of Medicine, Detroit, MI 48201, USA. | | Source | J Viral Hepat 1999 Sep; 6(5):397-403. | | MeSH | Adjuvants, Immunologic
Adult
Antiviral Agents
DNA, Viral
Double-Blind Method
Female
Hepatitis B e Antigens
Hepatitis B virus
Hepatitis B, Chronic
Humans
Male
Middle Aged
Research Support, Non-U.S. Gov't
Thymosin
Treatment Outcome
| | Abstract | Previous clinical trials have suggested that thymosin alpha1 (Talpha1), an immunomodulatory peptide, may be effective in the treatment of chronic hepatitis B (CHB). The aim of this study was to determine the efficacy of Talpha1 in a multicentre, placebo-controlled and double-blind study of 97 patients with serum hepatitis B virus (HBV) DNA- and hepatitis B e antigen (HBeAg)-positive CHB. Patients who had been hepatitis B surface antigen (HBsAg) positive for at least 12 months entered a 3-month screening period prior to randomization. Forty-nine patients received Talpha1 (1.6 mg) and 48 patients received placebo, twice weekly for 6 months, and were followed-up for an additional 6 months. At inclusion, both groups were comparable for age, gender, histological grading, and aminotransferase and HBV DNA levels. A complete response to treatment, defined as a sustained serum HBV DNA-negative status (two negative results at least 3 months apart) during the 12-month study, with negative HBV DNA and HBeAg values at month 12, was seen in seven (14%) patients given Talpha1 and in two (4%) patients treated with placebo (P = 0.084). Five (10%) patients given Talpha1 and four (8%) patients given placebo exhibited a delayed response (defined as sustained serum HBV DNA negativity achieved after the 12-month study period with negative HBV DNA and HBeAg values at the last assessment). A total of 12 (25%) patients given Talpha1 and six (13%) patients given placebo showed a sustained loss of HBV DNA with a negative HBeAg value during or following the 12-month study period (P < 0.11). These results do not confirm observations of treatment efficacy reported in other clinical studies. | | Language | eng | | Pub Type(s) | Clinical Trial
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
| | PubMed ID | 10607256 |
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