Long-Term Safety, Tolerability and Efficacy of OMS906 in Paroxysmal Nocturnal Hemoglobinuria
This research study is about a new medicine called OMS906 for adults with a rare blood condition called Paroxysmal Nocturnal Hemoglobinuria, or PNH. The main purpose is to see how safe the drug is and if people can take it without too many problems over a long period. We also want to find out if OMS906 continues to be helpful for PNH patients. Participants will receive OMS906 directly into their bloodstream (intravenously) once every eight weeks. This study is an extension for people who have already taken part in a previous OMS906 study, allowing researchers to gather more information on its long-term effects.
At a glance
What is this study about?
This study is designed for adults who have a rare blood condition called Paroxysmal Nocturnal Hemoglobinuria (PNH). PNH is a condition where red blood cells are destroyed too early, which can lead to anaemia, tiredness, and other health issues. The study is investigating a new medication called OMS906.
The main goal of this research is to understand how safe OMS906 is when given over a long time. Researchers also want to see if patients can comfortably continue taking the drug without bothersome side effects. On top of that, the study aims to check if OMS906 remains effective in treating PNH symptoms and improving patient health over an extended period. This is important information for doctors and patients to know if this medication could be a good long-term treatment option.
This specific study is an 'extension study,' meaning it's for people who have already been part of an earlier trial testing OMS906. This allows researchers to gather even more information on the drug's long-term effects, which is crucial for developing new medicines.
Key takeaways
- This study is for adults with Paroxysmal Nocturnal Hemoglobinuria (PNH).
- It's an extension study for people who have already tried OMS906.
- The main aims are to check the drug's long-term safety and whether it continues to work.
- The drug is given through an IV every eight weeks.
- Careful checks on your health will be part of the study.
Who may be eligible?
To join this study, you must have already completed a previous study involving OMS906 for PNH. You need to be at least 18 years old.
For female participants who could become pregnant, you must have a negative pregnancy test before each dose and use very reliable birth control throughout the study and for 20 weeks after your last dose. Male participants with a female partner who could become pregnant also need to use very reliable birth control during the study and for 20 weeks after their last dose.
Important requirements also include being up to date with certain vaccinations (for Neisseria meningitidis, Streptococcus pneumonia, and Hemophilus influenza) and agreeing to keep them current. You also cannot have certain low blood counts, severe liver problems (unless directly caused by PNH), a history of serious allergic reactions to similar medications, or current unresolved severe infections. If you are pregnant, planning to become pregnant, or breastfeeding, you cannot take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Have you already completed a previous study with OMS906 for PNH?
- Are you 18 years old or older?
- Are you up-to-date with your vaccinations for meningitis, pneumonia, and Haemophilus influenza?
- Are you able and willing to use highly effective birth control if you or your partner could become pregnant?
- Do you have good overall health, without certain severe infections or very low blood counts?
What does participation involve?
If you join this study, you will receive the study drug, OMS906, through an intravenous (IV) drip. This means it will be given directly into your vein. Each dose will be 5 mg for every kilogram of your body weight. You will receive this IV infusion every eight weeks. The study will involve regular visits to the clinic for these infusions, as well as blood tests and other checks to monitor your health, how the drug is affecting you, and if it's working. The total number of infusions and the overall length of your participation will depend on how the study progresses, but it is designed to look at long-term effects.
Potential risks and benefits
Locations (5)
- Omeros Investigational SiteVerified postcodeAachen, Germany· Not yet recruiting
- Omeros Investigational SiteVerified postcodeUlm, Germany· Not yet recruiting
- Omeros Investigational SiteVerified postcodeLausanne, Switzerland· Recruiting
- Omeros Investigational SiteVerified postcodeKyiv, Ukraine· Not yet recruiting
- Omeros Investigational SiteVerified postcodeLeeds, United Kingdom· Not yet recruiting
Common questions
What is PNH?
PNH (Paroxysmal Nocturnal Hemoglobinuria) is a rare blood condition where red blood cells are destroyed too quickly, leading to symptoms like tiredness, shortness of breath, and dark urine.
What is OMS906?
OMS906 is a new experimental drug being tested to see if it can help treat PNH.
How will I receive the drug?
You will receive the drug as an infusion directly into your vein (like a drip) every eight weeks.
Is this a new study for me?
No, this study is specifically for people who have already participated in an earlier study with OMS906 for PNH.
What is the main goal of this study?
The main goal is to check how safe OMS906 is over a long time and if people can continue taking it without too many problems.
How to find out more
Omeros Clinical Trial Information
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.