Safety of KN057 Prophylaxis in Patients With Haemophilia A or B

Recruiting Phase 3 Interventional Study
Hemophilia A or B
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 – 65
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
70 (estimated)
Sponsor
Suzhou Alphamab Co., Ltd. · Industry
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About This Trial
The purposes of this open-label, multicenter III clinical trial are to evaluate the safety and efficacy of long-term preventive treatment with KN057 in Haemophilia A or B patients with or without inhibitors, and to assess the pharmacokinetic characteristics of the new and old processes KN057. The participants in Part PK will be randomly assigned to Old process Group or New process Group in a 1:1 …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male, 12 to 65 years old at the time of signing informed consent, body weight ≥30 kg and BMI \<28 kg/m\^2 at screening. 2. For participates with inhibitors: Tested positive for high-titer FVIII or FIX inhibitors (≥ 5 BU/mL) at screening; or tested positive for low-titer FVIII…
Contacts

Yanrong Dong, Master

+86 18914005458

yanrongdong@alphamab.com

CONTACT