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Clinical Trials in India / 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 India tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2024-05-08
Last updated
2026-06-04

Condition(s) studied

Atypical Hemolytic Uremic Syndrome

Investigational drug(s) / intervention(s)

Iptcaopan 200 mg

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

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
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)

Trial sites (9)

FacilityCityRegionStatus
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 India

Other trials for the same condition

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 India