A study following people with haemophilia A and B, with or without inhibitors, when on usual treatment (explorerââ??¢6)

Not Applicable

• Conditions: Health Condition 1: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism

• Registration Number: CTRI/2019/03/018292
• Lead Sponsor: ovo Nordisk India Private Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Informed consent obtained before any study-related activities. Study-related activities are any

procedures that are carried out as part of the study, including activities to determine eligibility

for the study.

2. Male, age � 12 years at the time of signing informed consent.

3. Severe (FVIII activity < 1%) congenital haemophilia A or severe (FIX activity < 1%) congenital

haemophilia B or congenital haemophilia A or B with inhibitors, based on medical records at

the full discretion of the treating physician.

4. Patients with CHwI treated on-demand: � 6 treated (with bypassing agent) bleeding episodes

within 24 weeks before screening (visit 1) and patients with severe congenital HA/HB treated

on-demand: � 5 treated (with factor product) bleeding episodes within 24 weeks before

screening (visit 1).

5. Patients with congenital haemophilia with inhibitors treated with FEIBA�® prophylaxis: â�¥ 2

treated bleeding episodes within 24 weeks before screening (visit 1).

Exclusion Criteria

1. Known or suspected hypersensitivity to monoclonal antibodies.

2. Previous participation in this study. Participation is defined as signed informed consent.

3. Any disorder, except for conditions associated with congenital haemophilia, which in the

physicianââ?¬•s opinion might jeopardise patientââ?¬•s safety or compliance with the protocol.

4. Previous treatment with concizumab. Previous treatment is defined as two or more doses

administered.

5. Planned FVIII/FIX Immune Tolerance Induction (ITI) regimens during the study.

6. Current or planned treatment with emicizumab.

7. Any known congenital or acquired coagulation disorder other than congenital haemophilia.

Study & Design

• Study Type: Observational
• Study Design: Not specified