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Last Updated: November 18, 2024

CLINICAL TRIALS PROFILE FOR IPTACOPAN HYDROCHLORIDE


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All Clinical Trials for IPTACOPAN HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT04557462 ↗ A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open Label Iptacopan/LNP023 in Participants With Primary IgA Nephropathy Recruiting Novartis Pharmaceuticals Phase 3 2021-09-20 The purpose of this study is to evaluate the long-term safety and tolerability, of open label iptacopan in primary IgA nephropathy participants who have completed either the CLNP023X2203 or CLNP023A2301 clinical trials. The open-label design of the current study is appropriate to provide study participants the opportunity to receive treatment with iptacopan until marketing authorizations are received and the drug product becomes commercially available while enabling collection of long-term safety and tolerability data for the investigational drug. Furthermore efficacy assessments conducted every 6 months will afford the opportunity to evaluate the clinical effects of iptacopan on long-term disease progression.
NCT04747613 ↗ Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria Recruiting Novartis Pharmaceuticals Phase 3 2021-07-27 This study is an open-label, single arm, multicenter, roll-over extension study to characterize long-term safety, tolerability and efficacy of iptacopan and to provide access to iptacopan to patients with PNH who have completed Novartis-sponsored Phase 2 or 3 studies with iptacopan
NCT04817618 ↗ Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy. Recruiting Novartis Pharmaceuticals Phase 3 2021-07-28 The study is designed as a multicenter, randomized, double-blind, parallel group, placebo-controlled study to evaluate the efficacy and safety of iptacopan (LNP023) in complement 3 glomerulopathy.
NCT04820530 ↗ Study of Efficacy and Safety of Twice Daily Oral Iptacopan (LNP023) in Adult PNH Patients Who Are Naive to Complement Inhibitor Therapy Recruiting Novartis Pharmaceuticals Phase 3 2021-07-19 The purpose of this Phase 3 study is to determine whether iptacopan is efficacious and safe for the treatment of PNH patients who are naive to complement inhibitor therapy
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for IPTACOPAN HYDROCHLORIDE

Condition Name

Condition Name for IPTACOPAN HYDROCHLORIDE
Intervention Trials
Atypical Hemolytic Uremic Syndrome 3
Paroxysmal Nocturnal Hemoglobinuria 2
C3G 1
Cold Agglutinin Disease (CAD) 1
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Condition MeSH

Condition MeSH for IPTACOPAN HYDROCHLORIDE
Intervention Trials
Hemolysis 3
Azotemia 3
Atypical Hemolytic Uremic Syndrome 3
Hemoglobinuria, Paroxysmal 3
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Clinical Trial Locations for IPTACOPAN HYDROCHLORIDE

Trials by Country

Trials by Country for IPTACOPAN HYDROCHLORIDE
Location Trials
Japan 5
Italy 3
Spain 2
Korea, Republic of 2
France 2
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Clinical Trial Progress for IPTACOPAN HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for IPTACOPAN HYDROCHLORIDE
Clinical Trial Phase Trials
Phase 3 9
Phase 2 3
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for IPTACOPAN HYDROCHLORIDE
Clinical Trial Phase Trials
Not yet recruiting 7
Recruiting 6
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Clinical Trial Sponsors for IPTACOPAN HYDROCHLORIDE

Sponsor Name

Sponsor Name for IPTACOPAN HYDROCHLORIDE
Sponsor Trials
Novartis Pharmaceuticals 13
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Sponsor Type

Sponsor Type for IPTACOPAN HYDROCHLORIDE
Sponsor Trials
Industry 13
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