A Multi-center, Single Arm, Open-label Extension Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Iptacopan in Participants With Atypical Hemolytic Uremic Syndrome (aHUS) Who Have Completed a Preceding Iptacopan Phase 3 Study in aHUS

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Signed informed consent must be obtained prior to participation in the open label extension study

• Willing and able to comply with the study Schedule of Activities

• Participants who have completed the full study treatment period of any prior Novartis sponsored iptacopan Phase 3 clinical trial in aHUS, are still on iptacopan study treatment and derive benefit from it as per Investigator's judgement

• 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)

Locations
Other Locations
Brazil
Novartis Investigative Site
RECRUITING
Rio De Janeiro
Novartis Investigative Site
RECRUITING
São Paulo
China
Novartis Investigative Site
RECRUITING
Beijing
India
Novartis Investigative Site
RECRUITING
Nagpur
Novartis Investigative Site
RECRUITING
Pune
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
+41613241111
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2024-05-08
Estimated Completion Date: 2033-01-03
Participants
Target number of participants: 125
Treatments
Experimental: Iptacopan 200 mg
Open label , single arm
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov