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Tests treatment safety and results for Atypical Hemolytic Uremic Syndrome
Official title Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS
ClinicalTrials.gov ID: NCT05795140
What this study is testing
What is Iptcaopan 200 mg?
Iptcaopan 200 mg is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for atypical hemolytic uremic syndrome.
Also referred to as LNP023.
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 is a multicenter, single arm, open-label, extension study to evaluate the long-term safety, tolerability, and efficacy of iptacopan in participants with aHUS.
- Phase 3: a large, late-stage study
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 100
You may be able to join if
- Signed informed consent must be obtained prior to participation in the open label extension study
- Willing and able to comply with the study Schedule of Activities
- Participants who have completed the full study treatment period of any prior "Novartis sponsored" iptacopan Phase 3 clinical trial in aHUS (e.g...
- Prior vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e., any...
You likely can't join if
- Concomitant treatment with any complement inhibitor as well as concomitant treatment with any of the prohibited drugs
- Any comorbidity or medical condition (including but not limited to any active systemic bacterial, viral or fungal infection or malignancy) that, in...
- Active infection or history of recurrent invasive infections caused by encapsulated bacteria such as Neisseria meningitidis, Streptococcus pneumoniae...
- History of hypersensitivity to iptacopan or its excipients or to drugs of similar chemical classes
- Pregnant or nursing (lactating) women
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of...
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
- Rio de Janeiro, Brazil
- Beijing, China
- Ostrava, Poruba, Czechia
- Nagpur, Maharashtra, India
- Pune, Maharashtra, India
- Iruma-gun, Saitama, Japan
- Ankara, Yenimahalle, Turkey (Türkiye)
- Mersin, Yenisehir, Turkey (Türkiye)
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 - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil; Rio de Janeiro, Brazil; Beijing, China; Ostrava, Poruba, Czechia; Nagpur, Maharashtra, India; Pune, Maharashtra, India and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.