NCT03449342|CompletedPhase 4ResultsFDA Drug

Research Study to Look at Side Effects During Regular Injection With Factor VIII Medicine Named Turoctocog Alfa for a 8 Weeks Period

guardian 10

Safety of Turoctocog Alfa for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Patients With Moderate or Severe Haemophilia A in India

Novo Nordisk A/S ClinicalTrials.gov

Compare

3 other identifiers

NN7008-43042017-002281-46U1111-1179-5950

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredFeb 2018

StartedMar 2018

CompletionApr 2019

Brief Summary

This study will test the well-known medicine turoctocog alfa for any side effects. The purpose is to test turoctocog alfa for any side effects in the Indian population. The participants will get turoctocog alfa. Turoctocog alfa is already a well-known medicine in India, and can be prescribed by the study doctor. The participants will get an injection every second day or 3 times per week. This is decided by the study doctor. The study doctor will decide the amount and how often the participants must take the medicine. The study will last for about 16 weeks. The participants will have 5 visits with the study doctor. If the participants agree to participate in this study, the participants will receive the first injection at the second visit, thereafter the participants will be trained to do the injection by themself.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_4

Timeline

Completed

Started Mar 2018

Geographic Reach

1 country

9 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

February 22, 2018

Completed

6 days until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed

1 day until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 25, 2019

Completed

28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 22, 2019

Completed

11 months until next milestone

Results Posted

Study results publicly available

March 18, 2020

Completed

Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

1.1 years

First QC Date

February 22, 2018

Results QC Date

January 27, 2020

Last Update Submit

April 16, 2020

Conditions

Congenital Bleeding Disorder Haemophilia A

Outcome Measures

Primary Outcomes (1)

Occurrence of Confirmed FVIII Inhibitor Development (≥ 0.6 BU)
The number of participants who confirmed the presence of FVIII inhibitor development (≥ 0.6 BU) during 8 weeks of treatment period.
Weeks 0-8

Secondary Outcomes (4)

Incidence of Adverse Drug Reactions (ARs) and Serious Adverse Reactions (SARs)
Weeks 0-12
Number of Bleeding Episodes With Successful Haemostatic Effect of Turoctocog Alfa
Weeks 0-8
Total Annualised Consumption of Turoctocog Alfa
Weeks 0-8
Incidence of Allergic or Infusion Reactions Related to the Trial Product
Weeks 0-12

Study Arms (1)

Turoctocog alfa

EXPERIMENTAL

Previously treated moderate or severe haemophilia A patients will receive routine prophylaxis treatment and treatment of bleeding episodes.

Drug: turoctocog alfa

Interventions

turoctocog alfaDRUG

Patients will receive standard prophylaxis treatment and treatment of bleeding episodes, according to label. Trial product will be administered as intravenous injections (i.v.)

Turoctocog alfa

Eligibility Criteria

Age12 Years+

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.