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NCT05485948
PHASE2

A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU

Sponsor: PharmaEssentia

View on ClinicalTrials.gov

Summary

This study is a phase II single-arm study designed to evaluate the efficacy and safety of P1101 in Chinese PV patients who are intolerance or resistance to HU.

Official title: A Phase II Single-Arm Multicenter Study to Access Efficacy and Safety of P1101 in Chinese Polycythemia Vera Patients Who Are Intolerant or Resistance to Hydroxyurea

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

49

Start Date

2021-10-08

Completion Date

2027-07

Last Updated

2025-08-03

Healthy Volunteers

No

Interventions

DRUG

Ropeginterferon alfa-2b

Initial dose of 250 µg at Week 0, a medium dose of 350 µg at Week 2, a target dose of 500 µg at Week 4, and a maintenance dose of 500 µg until Week 52.

Locations (14)

Peking Union Medical College Hospital

Beijing, China

Xiangya Hospital Central South University

Changsha, China

The First Affiliated Hospital of Chongqing Medical Universit

Chongqing, China

Nanfang Hospital affiliated to Southern Medical University

Guangzhou, China

Anhui Provincial Hospital

Hefei, China

Huashan Hospital affiliated to Fudan University

Shanghai, China

Ruijin Hospital affiliated to Shanghai Jiaotong University

Shanghai, China

Shenzhen Second People's Hospital

Shenzhen, China

The First Affiliated Hospital of Soochow University

Suzhou, China

Institute of Hematology &Blood Diseases Hospital ,Chinese Academy of medical science & Peking Union Medical College

Tianjin, China

The Second Hospital of Tianjin Medical University

Tianjin, China

Zhongnan Hospital affiliated to Wuhan University

Wuhan, China

The First Affiliated Hospital Zhejiang University of Medicine

Zhejiang, China

Henan Cancer Hospital

Zhengzhou, China