Damoctocog alfa pegol (Jivi, BAY94-9027) for Hemophilia A

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hemophilia A+3 MoreDamoctocog alfa pegol (Jivi, BAY94-9027) - Biological
Eligibility
7 - 11
Male
What conditions do you have?
Select

Study Summary

This trial is looking for a better way to treat hemophilia A, a genetic disorder where the body does not create enough of a protein called clotting factor 8 (FVIII) present in the blood.

Eligible Conditions
  • Hemophilia A
  • Treatment of Bleeding
  • Prophylaxis of Bleeding
  • Children

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Up to 24 months

Month 6
Anti-drug antibody (ADA) development
The number of participants with confirmed Factor VIII inhibitors
Up to 24 months
Annualized bleeding rate (ABR)
BAY94-9027 consumption
Number of infusions/month and year (Annualized Infusion Rate)
Up to 6 months
AESI (hypersensitivity and loss of efficacy) associated with the first 4 exposure days leading to discontinuation
Adverse drug reactions (ADRs)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

pd vWF/FVIII
17%Pyrexia
12%Nasopharyngitis
8%Cough
8%Upper respiratory tract infection
6%Vomiting
6%Viral infection
5%Bronchitis
5%Diarrhoea
3%Anaemia
2%Subcutaneous haematoma
2%Pharyngitis
2%Head Injury
1%Road traffic accident
1%Vessel puncture site haemorrhage
1%Haemorrhagic anaemia
1%Hypersomnia
1%Haemorrhage intracranial
1%Skin haemorrhage
1%Urinary tract infection
1%Cerebral haemorrhage
1%Nausea
1%Haemorrhage
1%Pancytopenia
1%Seizure
1%Speech disorder developmental
1%Abdominal wall haemorrhage
1%Epidural Haemorrage
1%Haematemesis
1%Hemiparesis
1%Circumcision
1%Haemarthrosis
1%Hemiplegia
1%Lymphadenopathy
1%Muscle haemorrhage
1%Subdural haematoma
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT01064284) in the pd vWF/FVIII ARM group. Side effects include: Pyrexia with 17%, Nasopharyngitis with 12%, Cough with 8%, Upper respiratory tract infection with 8%, Vomiting with 6%.

Trial Design

1 Treatment Group

Main study (Part A) and the extension study (Part B)
1 of 1

Experimental Treatment

33 Total Participants · 1 Treatment Group

Primary Treatment: Damoctocog alfa pegol (Jivi, BAY94-9027) · No Placebo Group · Phase 3

Main study (Part A) and the extension study (Part B)
Biological
Experimental Group · 1 Intervention: Damoctocog alfa pegol (Jivi, BAY94-9027) · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Damoctocog alfa pegol
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months

Who is running the clinical trial?

BayerLead Sponsor
2,150 Previous Clinical Trials
23,875,094 Total Patients Enrolled
59 Trials studying Hemophilia A
4,950 Patients Enrolled for Hemophilia A

Eligibility Criteria

Age 7 - 11 · Male Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to complete training in the use of the EPD and to document infusions during the study.