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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

Study 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.
Secondary outcome measures
Change in HCV RNA levels from baseline throughout the study.
The proportion of subjects who experience virological failure throughout the study.
The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.
+1 more
Other outcome measures
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.

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

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
Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection
2013. "Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01872936.
All > Autoimmune Hepatitis > Hepatitis C
~2 spots leftby Apr 2025
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