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Antisense Oligonucleotide

Miravirsen monthly dosing for Chronic Hepatitis C

Phase 2
Waitlist Available
Research Sponsored by Santaris Pharma A/S
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 66 weeks
Awards & highlights
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.

Eligible Conditions
  • Chronic Hepatitis C

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~66 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 66 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Other study objectives
Plasma pharmacokinetics (AUC, Cmax, tmax) for miravirsen, telaprevir, and ribavirin levels will be determined.
Urine pharmacokinetics for miravirsen levels will be determined.
Viral resistance analysis at baseline and throughout the study.

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Miravirsen monthly dosingExperimental Treatment3 Interventions
Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 3 monthly doses at 7 mg/kg in combination with telaprevir and ribavirin.
Group II: Miravirsen every other week dosingExperimental Treatment3 Interventions
Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 6 every other week doses at 5 mg/kg in combination with telaprevir and ribavirin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Telaprevir
FDA approved
Ribavirin
FDA approved

Find a Location

Who is running the clinical trial?

Santaris Pharma A/SLead Sponsor
9 Previous Clinical Trials
245 Total Patients Enrolled
Michael Hodges, MDStudy DirectorSantaris Pharma A/S
1 Previous Clinical Trials
21 Total Patients Enrolled
~2 spots leftby Nov 2025
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