Randomized, double-blind, placebo-controlled trial of bovine lactoferrin in patients with chronic hepatitis C

Hideki Ueno, Tosiya Sato, Seiichiro Yamamoto, Katsuaki Tanaka, Shinichi Ohkawa, Hitoshi Takagi, Osamu Yokosuka, Junji Furuse, Hidetsugu Saito, Akira Sawaki, Hiroshi Kasugai, Yukio Osaki, Shigetoshi Fujiyama, Keiko Sato, Keiji Wakabayashi, Takuji Okusaka

Research output: Contribution to journalArticle

23 Citations (Scopus)

Abstract

Several studies have suggested that lactoferrin administration may decrease the serum level of hepatitis C virus (HCV) RNA in patients with chronic hepatitis C. The aim of the present study was to confirm the efficacy of orally administered bovine lactoferrin (bLF) in patients with chronic hepatitis C. The patients with chronic hepatitis C randomly received either oral bLF at a dose of 1.8.g daily for 12.weeks, or an oral placebo. The primary endpoint was the virologic response, defined as a 50% or greater decrease in serum HCV RNA level at 12.weeks compared with the baseline. The secondary endpoint was the biochemical response, which was defined as a 50% or greater decrease in the serum alanine aminotransferase (ALT) level at 12.weeks compared with the baseline. One hundred and ninety-eight of 199 patients were evaluable for efficacy and safety. bLF treatment was well tolerated and no serious toxicities were observed. A virologic response was achieved in 14 of 97 patients (14.4%) in the bLF group, and 19 of 101 (18.8%) in the placebo group. There was no significant difference in virologic response rates between the two groups (-4.4%, 95% confidence interval -14.8, 6.1). In addition, bLF intake did not have any favorable effect on the serum ALT level. The virologic responses were not different between two groups in any subgroup analysis. In conclusion, orally administered bLF does not demonstrate any significant efficacy in patients with chronic hepatitis C.

Original languageEnglish
Pages (from-to)1105-1110
Number of pages6
JournalCancer Science
Volume97
Issue number10
DOIs
Publication statusPublished - 2006 Oct

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Lactoferrin
Chronic Hepatitis C
Placebos
Serum
Alanine Transaminase
Hepacivirus
RNA
Confidence Intervals
Safety

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Ueno, H., Sato, T., Yamamoto, S., Tanaka, K., Ohkawa, S., Takagi, H., ... Okusaka, T. (2006). Randomized, double-blind, placebo-controlled trial of bovine lactoferrin in patients with chronic hepatitis C. Cancer Science, 97(10), 1105-1110. https://doi.org/10.1111/j.1349-7006.2006.00274.x

Randomized, double-blind, placebo-controlled trial of bovine lactoferrin in patients with chronic hepatitis C. / Ueno, Hideki; Sato, Tosiya; Yamamoto, Seiichiro; Tanaka, Katsuaki; Ohkawa, Shinichi; Takagi, Hitoshi; Yokosuka, Osamu; Furuse, Junji; Saito, Hidetsugu; Sawaki, Akira; Kasugai, Hiroshi; Osaki, Yukio; Fujiyama, Shigetoshi; Sato, Keiko; Wakabayashi, Keiji; Okusaka, Takuji.

In: Cancer Science, Vol. 97, No. 10, 10.2006, p. 1105-1110.

Research output: Contribution to journalArticle

Ueno, H, Sato, T, Yamamoto, S, Tanaka, K, Ohkawa, S, Takagi, H, Yokosuka, O, Furuse, J, Saito, H, Sawaki, A, Kasugai, H, Osaki, Y, Fujiyama, S, Sato, K, Wakabayashi, K & Okusaka, T 2006, 'Randomized, double-blind, placebo-controlled trial of bovine lactoferrin in patients with chronic hepatitis C', Cancer Science, vol. 97, no. 10, pp. 1105-1110. https://doi.org/10.1111/j.1349-7006.2006.00274.x
Ueno, Hideki ; Sato, Tosiya ; Yamamoto, Seiichiro ; Tanaka, Katsuaki ; Ohkawa, Shinichi ; Takagi, Hitoshi ; Yokosuka, Osamu ; Furuse, Junji ; Saito, Hidetsugu ; Sawaki, Akira ; Kasugai, Hiroshi ; Osaki, Yukio ; Fujiyama, Shigetoshi ; Sato, Keiko ; Wakabayashi, Keiji ; Okusaka, Takuji. / Randomized, double-blind, placebo-controlled trial of bovine lactoferrin in patients with chronic hepatitis C. In: Cancer Science. 2006 ; Vol. 97, No. 10. pp. 1105-1110.
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abstract = "Several studies have suggested that lactoferrin administration may decrease the serum level of hepatitis C virus (HCV) RNA in patients with chronic hepatitis C. The aim of the present study was to confirm the efficacy of orally administered bovine lactoferrin (bLF) in patients with chronic hepatitis C. The patients with chronic hepatitis C randomly received either oral bLF at a dose of 1.8.g daily for 12.weeks, or an oral placebo. The primary endpoint was the virologic response, defined as a 50{\%} or greater decrease in serum HCV RNA level at 12.weeks compared with the baseline. The secondary endpoint was the biochemical response, which was defined as a 50{\%} or greater decrease in the serum alanine aminotransferase (ALT) level at 12.weeks compared with the baseline. One hundred and ninety-eight of 199 patients were evaluable for efficacy and safety. bLF treatment was well tolerated and no serious toxicities were observed. A virologic response was achieved in 14 of 97 patients (14.4{\%}) in the bLF group, and 19 of 101 (18.8{\%}) in the placebo group. There was no significant difference in virologic response rates between the two groups (-4.4{\%}, 95{\%} confidence interval -14.8, 6.1). In addition, bLF intake did not have any favorable effect on the serum ALT level. The virologic responses were not different between two groups in any subgroup analysis. In conclusion, orally administered bLF does not demonstrate any significant efficacy in patients with chronic hepatitis C.",
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