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Coagulation Factor

turoctocog alfa pegol for Hemophilia (pathfinder™6 Trial)

Phase 3
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up when the first 50 pups have reached at least 50 exposure days, and at end of trial. end of trial will be up to 4 years after the first patient has reached 100 exposure days
Awards & highlights

pathfinder™6 Trial Summary

This trial is for a new haemophilia A treatment. It is investigating how safe and effective it is in patients who have not been treated before.

Eligible Conditions
  • Congenital Hematological Disorder
  • Hemophilia

pathfinder™6 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~when the first 50 pups have reached at least 50 exposure days, and at end of trial. end of trial will be up to 4 years after the first patient has reached 100 exposure days
This trial's timeline: 3 weeks for screening, Varies for treatment, and when the first 50 pups have reached at least 50 exposure days, and at end of trial. end of trial will be up to 4 years after the first patient has reached 100 exposure days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood Coagulation Factor
Secondary outcome measures
Consumption of N8-GP for prophylaxis (number of injections and U/Kg per month and per year)
Hemorrhage
Frequency of adverse events including serious adverse events and medical events of special interest
+5 more

Side effects data

From 2018 Phase 3 trial • 36 Patients • NCT01489111
21%
Constipation
11%
Nausea
9%
C-reactive protein increased
9%
Haemoglobin decreased
9%
Procedural pain
8%
Pyrexia
6%
Vomiting
6%
Alanine aminotransferase increased
6%
Diarrhoea
6%
Post procedural inflammation
2%
Mobility decreased
2%
Pancreatitis acute
2%
Ischaemia
2%
Tooth extraction
2%
Haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)

pathfinder™6 Trial Design

1Treatment groups
Experimental Treatment
Group I: 50 EDs (exposure days)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
turoctocog alfa pegol
2012
Completed Phase 3
~520

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,943 Total Patients Enrolled
1 Trials studying Hemophilia
100 Patients Enrolled for Hemophilia
Global Clinical Registry (GCR, 1452)Study DirectorNovo Nordisk A/S
778 Previous Clinical Trials
767,322 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the turoctocog alfa pegol drug been cleared by the FDA?

"Turoctocog alfa pegol is in Phase 3 of clinical trials, which implies that while there is data supporting its efficacy, there is also data affirming its safety from multiple rounds of testing. Consequently, our team at Power rates its safety at a 3."

Answered by AI

What are some of the common indications for turoctocog alfa pegol?

"Turoctocog alfa pegol is an effective intervention for patients with hemophilia that are facing perioperative procedures or bleeding episodes."

Answered by AI

How many guinea pigs are in this test group?

"Presently, this clinical trial is not enrolling patients. It was originally posted on 6/26/2014, and updated for the last time on 3/18/2022. There are presently 490 studies actively looking for patients with hemophilia and 2 studies for turoctocog alfa pegol that are actively recruiting patients."

Answered by AI

Has turoctocog alfa pegol been studied before in other clinical trials?

"At the moment, turoctocog alfa pegol is being trialled in 2 active studies, both of which are in Phase 3. In total, there are 76 locations conducting these studies, with the majority being in Fuzhou, Fujian."

Answered by AI

Are research participants still being accepted for this trial?

"The information on clinicaltrials.gov suggests that this trial is not looking for any more patients at this time. This study was originally posted on 6/26/2014, with the latest update coming on 3/18/2022. There are 492 other trials that are still recruiting patients."

Answered by AI

Have there been other similar trials in the past?

"Turoctocog alfa pegol has been under medical scrutiny since 2014. The first clinical trial, which was sponsored by Novo Nordisk A/S, took place that same year. Since the initial study with 125 participants, turoctocog alfa pegol has been approved for Phase 3 drug trials. As of now, there are 2 ongoing studies involving turoctocog alfa pegol in 33 cities and 19 countries."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
2014. "Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02137850.
~12 spots leftby Apr 2025
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