Clinical Trials in Japan / NCT05795140
Recruiting
Phase 3
Evaluate Long-term Safety, Tolerability and Efficacy of Iptacopan in Study Participants With aHUS
NCT05795140 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Atypical Hemolytic Uremic Syndrome
Investigational drug(s) / intervention(s)
Iptcaopan 200 mg: Open label, participant specific kits, hard gelatin capsules to be taken twice a day
Study 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
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.
Primary outcome measure(s)
- Number of participants with adverse events and serious adverse events — Throughout the study duration, up to 4 years
Number of participants with adverse events and serious adverse events, including abnormal safety laboratory parameters, vital signs and ECGs
Trial sites (9)
| Facility | City | Region | Status |
|---|---|---|---|
| Novartis Investigative Site | São Paulo | São Paulo | Active Not Recruiting |
| Novartis Investigative Site | Rio de Janeiro | Brazil | Recruiting |
| Novartis Investigative Site | Beijing | China | Recruiting |
| Novartis Investigative Site | Ostrava | Poruba | Recruiting |
| Novartis Investigative Site | Nagpur | Maharashtra | Active Not Recruiting |
| Novartis Investigative Site | Pune | Maharashtra | Recruiting |
| Novartis Investigative Site | Iruma-gun | Saitama | Recruiting |
| Novartis Investigative Site | Ankara | Yenimahalle | Recruiting |
| Novartis Investigative Site | Mersin | Yenisehir | Recruiting |
More Novartis Pharmaceuticals trials in Japan
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Active, not recruiting
Other trials for the same condition
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05795140 on ClinicalTrials.gov ↗ ← All trials in Japan