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NCT05365217 | Active, not recruiting | Haemophilia B

A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B
Sponsor:

Novo Nordisk A/S

Brief Summary:

The study investigates how well the medicine called nonacog beta pegol (N9-GP) works in Chinese people with haemophilia B. Participants will be treated with N9-GP. This is a medicine that doctors can already prescribe in other countries. The medicine will be injected into a vein (intravenous injection). At the visits to the clinic, the medicine will be injected by the study doctor. When treating themselves at home, participants inject the medicine using a needle and vial set. The study will last for about 12-16 months. The participants will have between 9 and 19 visits to the clinic and possibly also some phone calls with the study doctor. At all visits to the clinic, the participants will have blood samples taken.

Condition or disease

Haemophilia B

Intervention/treatment

Nonacog beta pegol

Phase

Phase 3

Study Type : Interventional
Estimated Enrollment : 30 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : A Multi-centre, Open-label Trial Evaluating Efficacy, Safety and Pharmacokinetics of Nonacog Beta Pegol When Used for Treatment and Prophylaxis of Bleeding Episodes in Chinese Patients With Haemophilia B
Actual Study Start Date : May 18, 2022
Estimated Primary Completion Date : May 16, 2024
Estimated Study Completion Date : June 14, 2024
Arm Intervention/treatment

Experimental: Arm A - Nonacog beta pegol (On-demand/Prophylaxis)

Participants on on-demand treatment for 28 weeks, thereafter prophylactic treatment

Drug: Nonacog beta pegol

Experimental: Arm B - Nonacog beta pegol (Prophylaxis)

Participants on prophylactic treatment only

Drug: Nonacog beta pegol
Ages Eligible for Study: 12 Years to 70 Years
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
  • Male Chinese patient with moderate to severe congenital haemophilia B with a factor IX (FIX) activity less than or equal to 2 percent according to medical records.
  • Aged 12-70 years (both inclusive) at the time of signing informed consent.
  • History of at least 100 exposure days (EDs) to products containing FIX.1.
  • Patients currently on prophylaxis or patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months.
  • The patient, legally authorised representative (LAR) and/or caregiver are capable of assessing a bleeding episode, keeping a diary, performing home treatment of bleeding episodes and otherwise following the trial procedures.
Exclusion Criteria
  • Known or suspected hypersensitivity to trial product or related products.
  • Previous participation in this trial. Participation is defined as signed informed consent.
  • Participation in any clinical trial of an approved or non-approved investigational medicinal product within 5 half-lives or 30 days from screening, whichever is longer.
  • Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR interviews.
  • Current FIX inhibitors greater than or equal to 0.6 Bethesda unit (BU).
  • HIV positive, defined by medical records, with CD4+ count less than or equal 200 per microlitre (μL) and a viral load greater than 200 particles per microlitre or greater than 400000 copies per millilitre (mL) within 6 months of the trial entry. If the data are not available in the medical records within the last 6 months, then the test must be performed at the screening visit.
  • Congenital or acquired coagulation disorder other than haemophilia B.
  • Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records).
  • Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than 3 times the upper limit of normal combined with total bilirubin greater than 1.5 times the upper limit of normal at screening.
  • Renal impairment defined as estimated glomerular filtration rate (eGFR) less than or equal to 30 mL/min/1.73 m^2 for serum creatinine measured at screening.
  • Any disorder, except for conditions associated with haemophilia B, which in the investigator's opinion might jeopardise the patient's safety or compliance with the protocol.
  • Platelet count less than 50×10^9/L at screening.
  • Immune modulating or chemotherapeutic medication.
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B

Location Details

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A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Beijing

Beijing Children's Hospital，Capital Medical University

Beijing, Beijing, China, 100045

Not yet recruiting

China, Beijing

Peking Union Medical College Hospital

Beijing, Beijing, China, 100730

Not yet recruiting

China, Fujian

Fujian Medical University Union Hospital-Hematology

F U axis, Fujian, China, 350001

Not yet recruiting

China, Guangdong

Hematology, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China, 510515

Not yet recruiting

China, Guizhou

The Affiliated hospital of Guizhou Medical University-Hemato

Guiyang, Guizhou, China, 550004

Not yet recruiting

China, Henan

Henan Cancer Hospital

Zhengzhou, Henan, China, 450003

Not yet recruiting

China, Hubei

Tongji Hospital, Tongji Medical College of HUST

Wuhan, Hubei, China, 430030

Not yet recruiting

China, Hunan

Xiangya Hospital Central-South University

Changsha, Hunan, China, 410008

Not yet recruiting

China, Jiangsu

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Not yet recruiting

China, Shandong

Jinan Central Hospital

Jinan, Shandong, China, 250013

Not yet recruiting

China, Shandong

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China, 266000

Not yet recruiting

China, Tianjin

Institute of hematology and Blood Diseases Hospital, Tianjin

Tianjin, Tianjin, China, 300020

Not yet recruiting

China, Yunnan

The Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China, 650101

Not yet recruiting

China, Zhejiang

The Children's Hospital, Zhejiang University school of medicine

Hangzhou, Zhejiang, China, 310052