Thrombomodulin alfa for acute exacerbation of idiopathic pulmonary fibrosis a randomized, double-blind placebo-controlled trial was written by Kondoh, Yasuhiro;Azuma, Arata;Inoue, Yoshikazu;Ogura, Takashi;Sakamoto, Susumu;Tsushima, Kenji;Johkoh, Takeshi;Fujimoto, Kiminori;Ichikado, Kazuya;Matsuzawa, Yasuo;Saito, Takefumi;Kishi, Kazuma;Tomii, Keisuke;Sakamoto, Noriho;Aoshima, Masahiro;Araya, Jun;Izumi, Shinyu;Arita, Machiko;Abe, Mitsuhiro;Yamauchi, Hiroyoshi;Shindoh, Joe;Suda, Takafumi;Okamoto, Masaki;Ebina, Masahito;Yamada, Yoshihito;Tohda, Yuji;Kawamura, Tetsuji;Taguchi, Yoshio;Ishii, Hiroshi;Hashimoto, Naozumi;Abe, Shinji;Taniguchi, Hiroyuki;Tagawa, Jun;Bessho, Koji;Yamamori, Natsuki;Homma, Sakae. And the article was included in American Journal of Respiratory and Critical Care Medicine in 2020.Quality Control of (Z)-Methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate ethanesulfonate The following contents are mentioned in the article:
Acute exacerbation during the course of idiopathic pulmonary fibrosis causes a poor prognosis. Coagulation abnormalities and endothelial damage are involved in its pathogenesis. Thrombomodulin alfa, a recombinant human soluble thrombomodulin, has anticoagulant and antiinflammatory effects. Several clin. studies have shown that thrombomodulin alfa may improve survival of acute exacerbation. To determine the efficacy and safety of thrombomodulin alfa compared with placebo in acute exacerbation of idiopathic pulmonary fibrosis. This randomized, double-blind placebo-controlled phase 3 study conducted at 27 sites in Japan involved patients with an acute exacerbation of idiopathic pulmonary fibrosis. Subjects were randomized 1:1 to receive placebo or thrombomodulin alfa (380 U/kg/d for 14 d by i.v. drip infusion). All subjects were treated with high-dose corticosteroid therapy. The primary endpoint was the survival proportion on Day 90. Of the 82 randomized subjects, 77 completed the study and were included in the full anal. set (thrombomodulin alfa, n = 40; placebo, n = 37). The survival proportions on Day 90 were 72.5% (29 of 40) in the thrombomodulin alfa group and 89.2% (33 of 37) in the placebo group, a difference of 216.7 percentage points (95% confidence interval, 233.8 to 0.4%; P = 0.0863). In the safety population (n = 80), bleeding adverse events occurred in the thrombomodulin alfa group (10 of 42; 23.8%) and the placebo group (4 of 38; 10.5%). Thrombomodulin alfa did not improve the 90-day survival proportion. The present results suggest that the use of thrombomodulin alfa for the treatment of acute exacerbation of idiopathic pulmonary fibrosis not be recommended. This study involved multiple reactions and reactants, such as (Z)-Methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate ethanesulfonate (cas: 656247-18-6Quality Control of (Z)-Methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate ethanesulfonate).
(Z)-Methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate ethanesulfonate (cas: 656247-18-6) belongs to piperazine derivatives. Piperazine belongs to the family of medicines called anthelmintics. Piperazine and its salts did not induce point mutations in a bacterial test. A series of mutagenicity studies in cells, both in vitro and in vivo, has been completed and showed no evidence of mutagenic effect.Quality Control of (Z)-Methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate ethanesulfonate
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Piperazine – Wikipedia,
Piperazines – an overview | ScienceDirect Topics