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A Phase III b, Single-arm, Multicenter, Optimal Dose Finding Study to Assess the Efficacy and Safety of P1101 in Japanese Patients With Polycythemia Vera (PV).

This is a Phase 3 single arm study to investigate efficacy and safety of P1101's rapid titration for adult Japanese patients with PV.

开始日期2023-10-17

申办/合作机构

PharmaEssentia Japan KK

NCT05231044 / Completed临床3期

A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy, Safety and PK Study of KX01 Ointment 1% in Japanese Adult Subjects With Actinic Keratosis on the Face or Scalp

This Phase III study is designed to evaluate the efficacy and safety of KX01 Ointment in adult participants when applied to an area of skin containing more than 1, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.

开始日期2021-12-21

申办/合作机构

药华医药股份有限公司

[+1]

NCT05245578 / Completed临床1期

Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese Healthy Male Subjects

Skin Irritation and Phototoxicity Study of KX01 Ointment 1% in Japanese healthy male subjects

开始日期2021-11-16

申办/合作机构

药华医药股份有限公司

[+1]

100 项与 PharmaEssentia Japan KK 相关的临床结果

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0 项与 PharmaEssentia Japan KK 相关的专利（医药）

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2

项与 PharmaEssentia Japan KK 相关的文献（医药）

2023-06-21·Experimental hematology & oncology

A new dosing regimen of ropeginterferon alfa-2b is highly effective and tolerable: findings from a phase 2 study in Chinese patients with polycythemia vera.

Letter

作者: Qin, Albert ; Shao, Zonghong ; Bai, Jie ; Sato, Toshiaki ; Jin, Jie ; Chen, Suning ; Wu, Daoxiang ; Urbanski, Raymond ; Zhang, Xuhan ; Li, Yaning ; Zagrijtschuk, Oleh ; Duan, Minghui ; Du, Xin ; Zhang, Lei ; Wang, Li ; Li, Pei ; Zuo, Xuelan ; Zhou, Hu ; Xu, Na ; Zhang, Sujiang ; Shen, Weihong ; Xiao, Zhijian ; Zhang, Jingjing ; Wang, Wei

Ropeginterferon alfa-2b represents a new-generation pegylated interferon-based therapy and is administered every 2-4 weeks. It is approved for polycythemia vera (PV) treatment in the United States and Europe with a starting dose of 100 µg (50 µg for patients receiving hydoxyurea) and intra-patient dose titrations up to 500 µg at 50 µg increments, which took approximately 20 or more weeks to reach a plateau dose level. This study aimed to assess ropeginterferon alfa-2b at an alternative dosing regimen with a higher starting dose and quicker intra-patient dose titrations, i.e., the 250-350-500 μg schema, in 49 Chinese patients with PV with resistance or intolerance to hydroxyurea. The primary endpoint of the complete hematologic response rate at treatment weak 24 was 61.2%, which was notably higher than 43.1% at 12 months with the approved dosing schema. The JAK2^V617F allele burden decreased from baseline to week 24 (17.8% ± 18.0%), with one patient achieving a complete molecular response. Ropeginterferon alfa-2b was well-tolerated and most adverse events (AEs) were mild or moderate. Common AEs included alanine aminotransferase and aspartate aminotransferase increases mostly at grade 1 or 2 levels. Patients did not present with jaundice or significant bilirubin level increase. No grade 4 or 5 AEs occurred. Seven patients (14.3%) experienced reversible, drug-related grade 3 AEs. No AEs led to treatment discontinuation. Ropeginterferon alfa-2b at the 250-350-500 μg regimen is highly effective and well-tolerated and can help patients achieve greater and rapid complete hematologic and molecular responses.Clinical Trial Registration: This trial is registered at ClinicalTrials.gov (Identifier: NCT05485948) and in China (China National Medical Products Administration Registration Number: CTR20211664).

2021-01-01·[Rinsho ketsueki] The Japanese journal of clinical hematology

[The effect of ferric citrate hydrate as an iron replacement therapy in Japanese patients with iron deficiency anemia].

Article

作者: Mitsui, Hironori ; Nemoto, Takanori ; Arita, Kojo ; Hanaki, Koji ; Akizawa, Tadao ; Komatsu, Norio

Patients with iron deficiency anemia (IDA) need to take oral iron preparations, which serve as the first-line treatment in IDA, for several months in order to replenish body iron stores after the improvement of anemia. However, existing oral iron preparations have concerns regarding its long-term use due to side effects, such as gastrointestinal symptoms. Previous clinical studies have shown that ferric citrate hydrate (FC) exhibits sufficient therapeutic efficacy in patients with IDA and lowers the risks of nausea and vomiting in comparison with existing oral iron preparations. In this study, we evaluated the efficacy and safety of FC administration at doses of 500 and 1,000 mg/day for up to 24 weeks as iron replacement therapy in patients with IDA. The results of this study showed that both the doses of FC improved anemia and iron-deficiency conditions and led to sufficient iron replacement response in most patients with IDA. No safety concerns were identified. Therefore, FC is expected to be a novel oral iron preparation for patients with IDA.

100 项与 PharmaEssentia Japan KK 相关的药物交易

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100 项与 PharmaEssentia Japan KK 相关的转化医学

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