COMPLETEDResults postedPhase 3

A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP) in children with severe haemophilia A who have undergone treatment with previous factor VIII (FVIII) products.

Sponsor

Novo Nordisk A/S

Enrollment

68 participants

Sites

51 locations

Start Date

February 2013

Completion

September 2014

Congenital Bleeding DisorderHaemophilia Aturoctocog alfa pegol

Enrollment & Timeline

Completed

Target N

participants

Sites

locations

Duration

5.6 years

total trial span

Rate

pts/month needed

At 51 sites, each site needs to enroll approximately 0.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

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Primary Outcomes

Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units

During the main phase of the trial (from 0-26 weeks of treatment)

The number of participants with inhibitory antibodies against coagulation factor VIII (FVIII) ≥0.6 Bethesda units was presented.

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Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials.

Tosetto Alberto, Neff Anne, Lentz Steven R et al.Haemophilia : the official journal of the World Federation of Hemophilia2020

DOI PubMed

Long-term safety and efficacy of N8-GP in previously treated pediatric patients with hemophilia A: Final results from pathfinder5.

Šaulytė Trakymienė Sonata, Economou Marina, Kenet Gili et al.Journal of thrombosis and haemostasis : JTH2021

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

COMPLETEDResults postedPhase 3

A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

Sponsor

Novo Nordisk A/S

Enrollment

68 participants

Sites

51 locations

Start Date

February 2013

Completion

September 2014

Congenital Bleeding DisorderHaemophilia Aturoctocog alfa pegol

Enrollment & Timeline

Completed

Target N

participants

Sites

locations

Duration

5.6 years

total trial span

Rate

pts/month needed

At 51 sites, each site needs to enroll approximately 0.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Primary Outcomes

Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units

During the main phase of the trial (from 0-26 weeks of treatment)

The number of participants with inhibitory antibodies against coagulation factor VIII (FVIII) ≥0.6 Bethesda units was presented.

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Tosetto Alberto, Neff Anne, Lentz Steven R et al.Haemophilia : the official journal of the World Federation of Hemophilia2020

DOI PubMed

Long-term safety and efficacy of N8-GP in previously treated pediatric patients with hemophilia A: Final results from pathfinder5.

Šaulytė Trakymienė Sonata, Economou Marina, Kenet Gili et al.Journal of thrombosis and haemostasis : JTH2021

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Eligibility

Min Age

0 Years

Max Age

11 Years

Sex

male

Healthy Volunteers

View full criteria

Inclusion Criteria:

* Male patients with severe congenital haemophilia A (FVIII activity level below 1%)
* Weight above or equal to 10 kg - Documented history of 150 exposure days (ED) to FVIII products for patients aged 6-11 years and above 50 ED to FVIII products for patients aged 0-5 years

Exclusion Criteria:

\- Any history of FVIII inhibitors