The Safety and Tolerability of SerpinPC in Healthy Men and in Men With Severe Blood Disorders (Haemophilia A and B)

Hemophilia A Clinical Trial

Official title:
An Adaptive Design, Phase I/IIa, Open Label, Multicentre, Single Dose Escalation and Multiple Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Intravenous and Subcutaneous Doses of SerpinPC in Healthy Male Volunteers and Male Participants With Severe Haemophilia A or B With or Without Inhibitors

Status Active, not recruiting

Clinical Trial Summary

The purpose of this study is to investigate the safety and activity in the body of a new drug called SerpinPC. The study will be split into 7 parts: Part 1a will be conducted in healthy male volunteers in the UK (up to 15) and Parts 1b, 2, 3, 4, 5 and 6 will be conducted in haemophilia A & B patients in Moldova and Georgia. Part 1a of the study will look at how safe the drug is when given as single doses to healthy volunteers at different strengths and via 2 different routes of administration (through a vein or via an injection under the skin). Parts 1b, 2, 3, 4, 5 and 6 of the study will look at the safety of the drug when given as an injection under the skin to patients with severe haemophilia A or B. The study will also investigate how the levels of the drug in the blood change over a period of time and how the drug acts in the body by taking blood samples. These blood samples will measure the concentration of the drug in the blood and measure certain aspects of the blood to determine how the drug affects them. The study sponsor (ApcinteX) is developing this drug for the treatment of haemophilia A and haemophilia B, which are 2 types of rare blood disorders which affect the body's ability to form blood clots. Patients who have haemophilia A and B do not have certain clotting factors in their blood which means that they experience difficulty in stopping bleeding after injury and can be prone to extended periods of bleeding. Current treatments for haemophilia involves injections which replace the missing factors in the blood. However these treatments are short term and therefore patients require regular treatments in order to manage the condition. Therefore, there is a need to develop more effective treatments which provide longer term benefits. The aim of SerpinPC is to prevent bleeding rather than to have to treat bleeds to minimise pain and damage after they have occurred.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04073498
Study type	Interventional
Source	ApcinteX Ltd
Contact
Status	Active, not recruiting
Phase	Phase 1/Phase 2
Start date	August 14, 2019
Completion date	October 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03834727` - Characterizing the Impact and Treatment of Reproductive Tract Bleeding on Women and Post-menarchal Girls With Bleeding Disorders
Completed	`NCT03191799` - A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors	Phase 3
Completed	`NCT01599819` - BAX 855 Dose-Escalation Safety Study	Phase 1
Terminated	`NCT04541628` - Safety & Efficacy of Encapsulated Allogeneic FVIII Cell Therapy in Haemophilia A	Phase 1/Phase 2
Completed	`NCT02847637` - A Clinical Trial to Evaluate Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants Without Inhibitors	Phase 3
Completed	`NCT04072237` - Study of Coagulation Faction VIIa Variant Marzeptacog Alfa (Activated) in Adult Subjects With Hemophilia	Phase 1
Completed	`NCT04085458` - Study to Gain More Information on How Safe and Effective Jivi Works in Patients With Severe Hemophilia A (Post-marketing Investigation)	Phase 4
Completed	`NCT04565236` - A Post Approval Commitment Study to Gain More Information on How Safe and Effective KOVALTRY is in Chinese Children, Adolescents /Adults With Severe Hemophilia A	Phase 4
Recruiting	`NCT05987449` - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Persons With Severe or Moderate Hemophilia A	Phase 1/Phase 2
Active, not recruiting	`NCT04621916` - Preventing Inhibitor Recurrence Indefinitely	Phase 4
Not yet recruiting	`NCT02888223` - Pharmacokinetic Study of SCT800 in Previously Treated Patients With Hemophilia A	Phase 1
Completed	`NCT02528968` - National Study of a Pharmacokinetic-Focused Educational Package for Patients With Severe Haemophilia A	N/A
Completed	`NCT02225483` - Phenotypic Heterogeneity in Hemophilia A: An Investigation of the Role of Platelet Function	N/A
Completed	`NCT02199717` - An Institutional Pilot Study to Investigate Physical Activity Patterns in Boys With Hemophilia	N/A
Completed	`NCT01217255` - Comparing the Burden of Illness of Hemophilia in the Developing and the Developed World
Completed	`NCT00969319` - Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America	N/A
Terminated	`NCT00995046` - Individually Tailored Prophylaxis in Patients With Severe Hemophilia A	N/A
Completed	`NCT00868530` - Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects	Phase 3
Completed	`NCT00839202` - Activity and Content of Factor VIII (FVIII) in Human Plasma: The Assessment of a Novel Immunoassay	N/A
Completed	`NCT00629837` - Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980	Phase 1