A Phase 2 Multicenter, Randomized, Open-label Study to Evaluate the Pharmacokinetic, Safety and Efficacy of Peginterferon Alfa-2b Injection in Subjects With Essential Thrombocythemia Who Are Resistant to or Intolerant of Hydroxyurea.

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a multicenter, randomized, open-label Phase 2 clinical study. It is aimed to enroll 27 essential thrombocytopenia (ET) patients who are resistant to or intolerant of hydroxyurea(HU). Eligible patients will be randomized to receive either Peginterferon α-2b 135 mcg or Peginterferon α-2b 180 mcg at a ratio of 1:2, and all subjects will go through a target treatment period (Weeks 1 \ Week 48), an extension treatment period (Weeks 49 \ Week 96) and a follow-up period (Weeks 97 \ Week 100). Pharmacokinetics, safety, efficacy will be evaluated.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Male or female subjects, aged greater or equal to 18 years old at screening;

• Subjects diagnosed as high-risk ET according to the World Health Organization (WHO) 2016 criteria:1) who is older than 60 years and JAK2V617F positive at screening, 2) or who previously suffered from disease-related thrombosis or hemorrhage;

• Subjects who have previously received HU for ET, and the time interval between the last HU dose and the first dose of the study drug should not be less than 7 days;

• Interferon treatment-naïve, and for those who have previously received interferon the the time interval between the last dose of interferon and randomization should not be less than 1 month;

• Patients with confirmed hydroxyurea resistance or intolerant, as at least one of the following criteria is met:

‣ Platelet count remain greater than 600×10\^9 /L after at least 3 months of HU treatment at a dose ≥2g/d (dose ≥2.5 g/d if subject weight \> 80 kg);

⁃ Platelet count greater than 400\*10\^9/L while white blood cell (WBC) count lower than 2.5\*10\^9/L, or platelet count greater than 400\*10\^9 /L while hemoglobin lower than 100 g/L at any dose of HU;

⁃ Presence of HU-related toxicities at any dose of HU: e.g. ulcers in legs, or any unacceptable skin mucosal manifestations or fever;

• Platelet counts \> 450\*10\^9/L at screening;

• Neutrophil count ≥1.0\*10\^9/L at screening;

• Haemoglobin ≥11 g/dL at screening for males and 10 g/dL for females at screening;

• There is no serious function damage in liver and kidney: total bilirubin ≤1.5 upper limit of normal (ULN), alanine aminotransferase≤2.0 ULN, aspartate aminotransferase≤2.0 ULN, prothrombin time is prolonged by less than 4 seconds, Creatinine clearance ≥50 mL/min (according to Cockcroft-Gault formula) at screening;

• Both male and female subjects must agree take an appropriate contraceptive method, including:

‣ Male subjects: must agree to use reliable contraception from inform consent until 6 months following the last dose of the study drug.

⁃ Female subjects: Must meet at least one of the following conditions:

• i) Women without childbearing potential; ii) Women of childbearing potential: no pregnant or breastfeed, negative in blood pregnancy test within 4 days prior to the first dosing, and must agree to use reliable contraception from inform consent until 6 months following the last dose of the study drug;

• Subjects understand the objective, characteristic, method and possible adverse reactions of the study, voluntarily participate in this study, and sign informed consent.

Locations
Other Locations
China
Peking Union Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Peking University People's Hospital
RECRUITING
Beijing
Union Hospital affiliated to Fujian Medical University
RECRUITING
Fujian
Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Harbin First Hospital
RECRUITING
Harbin
Henan Cancer Hospital
RECRUITING
Henan
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
The First Affiliated Hospital of Zhejiang University School of Medicine
RECRUITING
Zhejiang
Contact Information
Primary
Lei Zhang
zhanglei1@ihcams.ac.cn
13502118379
Backup
Rongfeng Fu
furongfeng@ihcams.ac.cn
13502118379
Time Frame
Start Date: 2024-08-29
Estimated Completion Date: 2027-09
Participants
Target number of participants: 27
Treatments
Experimental: Peginterferon α-2b 135 mcg dose group
Experimental: Peginterferon α-2b 180 mcg dose group
Sponsors
Leads: Xiamen Amoytop Biotech Co., Ltd.

This content was sourced from clinicaltrials.gov