Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria

Part of paid clinical trials in Duarte, California.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT04747613
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Paroxysmal Nocturnal Hemoglobinuria

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Iptacopan — DRUG
    Taken orally b.i.d. Dosage supplied: 200 mg Dosage form: hard gelatin capsule Route of administration: oral

Study Details

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

Key Dates

Start date
Jul 27, 2021
Status verified
May 2026
Primary completion
Oct 18, 2027
Completion
Oct 18, 2027

Study Design

Enrollment
208 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Iptacopan
    Participants will be receiving open label oral iptacopan 200 mg b.i.d monotherapy

Primary Outcome Measure

Proportion of participants with adverse events [ Time Frame: 60 months ]

Locations (11)

FacilityCityStateZIPSite coordinators
City Of HopeDuarteCalifornia91010-
City Of Hope National Med CenterDuarteCalifornia91010-
USC Norris Cancer CenterLos AngelesCalifornia90033-
Univ Cali Irvine ALS NeuromuscularOrangeCalifornia92868-
Univ of California Irvine (Chao Family Comprehensive Cancer Center)OrangeCalifornia92868-
Lakes ResearchMiami LakesFlorida33014-
Augusta UniversityAugustaGeorgia30912-
Augusta University GeorgiaAugustaGeorgia30912-
Montefiore Medical CenterThe BronxNew York10461-
Cleveland Clinic FoundationClevelandOhio44195-
Prisma Health UpstateGreenvilleSouth Carolina29615-

Find similar trials in Duarte, CA

By research site
City Of Hope· Duarte, CACity Of Hope National Med Center· Duarte, CAUSC Norris Cancer Center· Los Angeles, CAUniv Cali Irvine ALS Neuromuscular· Orange, CAUniv of California Irvine (Chao Family Comprehensive Cancer Center)· Orange, CALakes Research· Miami Lakes, FL

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