Haemophilia A study: NNC0442-0344 A
Official title A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A
ClinicalTrials.gov ID: NCT07220564
What this study is testing
What is NNC0442-0344 A?
An investigational oral medicine being studied for haemophilia A.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether Inno8 is safe for people with haemophilia A. It looks at how the medicine behaves at different amounts.
- Who it's for
- You may be able to join if you have haemophilia A and are willing to try a new medicine.
- What's involved
- You will take Inno8 at different amounts. You will have visits and tests to check safety.
- Time commitment
- The study lasts about 11 weeks and includes several visits during that time.
- Phase 1: an early, usually small safety study
- Time commitment: about 11 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64, men only. Healthy volunteers may be eligible.
You may be able to join if
- Male
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body weight greater than or equal to (≥) 45 kilograms (kgs).
- Diagnosis of congenital haemophilia A with factor VIII (FVIII) activity less than or equal to (≤) 15 percentage (%) with or without FVIII inhibitors...
You likely can't join if
- Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening.
- Body mass index ≥30.0 kilogram per square meter (kg/m\^2).
- Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis.
- Any clinical signs or established diagnosis of venous or arterial thromboembolic disease.
- Any known coagulation disorders other than haemophilia A.
- Ongoing or planned immune tolerance induction therapy.
See the full eligibility criteria
- Male
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body weight greater than or equal to (≥) 45 kilograms (kgs).
- Diagnosis of congenital haemophilia A with factor VIII (FVIII) activity less than or equal to (≤) 15 percentage (%) with or without FVIII inhibitors, based on medical records.
- Current or prior exposure to any prophylactic treatment for haemophilia A within 5 half-lives of the medicinal product by the time of screening.
- Body mass index ≥30.0 kilogram per square meter (kg/m\^2).
- Increased risk of thrombosis, e.g. known history of personal or first-degree relative(s) with unprovoked deep vein thrombosis.
- Any clinical signs or established diagnosis of venous or arterial thromboembolic disease.
- Any known coagulation disorders other than haemophilia A.
- Ongoing or planned immune tolerance induction therapy.
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
The study team makes the final eligibility decision.
Where it is enrolling
- Aurora, Colorado, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Hershey, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Innsbruck, Austria
- Vienna, Austria
- Berlin, Germany
- Hanover, Germany
- Florence, Italy
- Naples, Italy
- Bialystok, Poland
- Gdansk, Poland
- Warsaw, Poland
- Porto, Portugal
- Barcelona, Spain
- Madrid, Spain
- Málaga, Spain
- Malmö, Sweden
- Solna, Sweden
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 11 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Aurora, Colorado, United States; Indianapolis, Indiana, United States; Iowa City, Iowa, United States; Hershey, Pennsylvania, United States; Philadelphia, Pennsylvania, United States; Innsbruck, Austria and 18 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.