NCT05795140 Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS
| NCT ID | NCT05795140 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Atypical Hemolytic Uremic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 65 participants |
| Start Date | 2024-05-08 |
| Primary Completion | 2032-07-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 65 participants in total. It began in 2024-05-08 with a primary completion date of 2032-07-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the open label extension study 2. Willing and able to comply with the study Schedule of Activities 3. Participants who have completed the full study treatment period of any prior "Novartis sponsored" iptacopan Phase 3 clinical trial in aHUS (e.g. CLNP023F12301 , CLNP023F12302), are still on iptacopan study treatment and derive benefit from it as per Investigator's judgement 4. Prior vaccinations against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae infections should be up to date (i.e., any boosters required should be administered according to local guidelines) Exclusion Criteria: 1. Concomitant treatment with any complement inhibitor as well as concomitant treatment with any of the prohibited drugs 2. Any comorbidity or medical condition (including but not limited to any active systemic bacterial, viral or fungal infection or malignancy) that, in the opinion of the Investigator could put the participant at risk 3. Active infection or history of recurrent invasive infections caused by encapsulated bacteria such as Neisseria meningitidis, Streptococcus pneumoniae or Haemophilus influenzae 4. History of hypersensitivity to iptacopan or its excipients or to drugs of similar chemical classes 5. Pregnant or nursing (lactating) women 6. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of investigational drug and for 1 week after stopping of investigational drug. Other protocol-defined inclusion/exclusion criteria may apply.
Contact & Investigator
Novartis Pharmaceuticals
STUDY DIRECTOR
Novartis Pharmaceuticals
Frequently Asked Questions
Who can join the NCT05795140 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Atypical Hemolytic Uremic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05795140 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 65 participants.
Is NCT05795140 currently recruiting?
Yes, NCT05795140 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT05795140 trial being conducted?
This trial is being conducted at São Paulo, Brazil, Rio de Janeiro, Brazil, Beijing, China, Ostrava, Czechia and 5 additional locations.
Who is sponsoring the NCT05795140 clinical trial?
NCT05795140 is sponsored by Novartis Pharmaceuticals. The principal investigator is Novartis Pharmaceuticals at Novartis Pharmaceuticals. The trial plans to enroll 65 participants.