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Antisense Oligonucleotide

Mild hepatic impairment patients for Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (0 hour (pre-dose) 0.5 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour), day 2, day 3, day 4, day 8, day 30 and day 60
Awards & highlights

Study Summary

This was a Phase I, open-label, single-dose, parallel-group study in participants with mild hepatic impairment (HI) and healthy matched control participants with normal hepatic function designed to evaluate the PK of pelacarsen following a single 80 mg s.c. dose. Participants were matched by gender, age (±10 years), and body weight (±15%).

Eligible Conditions
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (0 hour (pre-dose) 0.5 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour), day 2, day 3, day 4, day 8, day 30 and day 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (0 hour (pre-dose) 0.5 hour, 1 hour, 1.5 hour, 2 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour), day 2, day 3, day 4, day 8, day 30 and day 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmacokinetic parameters of pelacarsen: AUCinf
Pharmacokinetic parameters of pelacarsen: AUClast
Pharmacokinetic parameters of pelacarsen: Cmax

Trial Design

2Treatment groups
Experimental Treatment
Group I: Mild hepatic impairment patientsExperimental Treatment1 Intervention
Participants with mild hepatic impairment
Group II: Healthy participantsExperimental Treatment1 Intervention
Matched healthy participants with normal hepatic function
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pelacarsen
2018
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,859 Previous Clinical Trials
4,198,227 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants
2021. "Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05026996.
~5 spots leftby Apr 2025
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