Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection

November 17, 2014 updated by: Santaris Pharma A/S

Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Genotype 1 Infection

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego
  • United States
    • Texas
      • Dallas, Texas, United States, 75203
        • The Liver Institute At Methodist Dallas Medical Center
      • Houston, Texas, United States, 77030
        • Research Specialists of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of chronic hepatitis C genotype 1 infection
  • BMI 18 and 38 kg/m2
  • Null responder to pegylated interferon alpha and ribavirin

Exclusion Criteria:

  • Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  • Significant liver disease in addition to hepatitis C
  • Decompensated liver disease medical history or current clinical features
  • Histologic evidence of hepatic cirrhosis
  • Concurrent clinically significant medical diagnosis (other than CHC)
  • Concurrent social conditions (e.g. drugs of abuse, alcohol excess, poor living accommodation)
  • Clinically significant illness within 30 days preceding entry into the study
  • Participated in an investigational drug study within 30 days or 5 half-lives, whichever is longer, prior to the start of study medication
  • History of clinically significant allergic drug reactions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Miravirsen every other week dosing
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.
Drug: Ribavirin
Other Names:
  • Copegus
Drug: Telaprevir
Other Names:
  • Incivek
Drug: Miravirsen
Other Names:
  • SPC3649
  • Miravirsen sodium
Other: Miravirsen monthly dosing
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.
Drug: Ribavirin
Other Names:
  • Copegus
Drug: Telaprevir
Other Names:
  • Incivek
Drug: Miravirsen
Other Names:
  • SPC3649
  • Miravirsen sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.
Time Frame: 42 weeks
42 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The proportion of subjects with undetectable HCV RNA levels at end of treatment.
Time Frame: 18 weeks
18 weeks
The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.
Time Frame: 66 Weeks
66 Weeks
Change in HCV RNA levels from baseline throughout the study.
Time Frame: 66 Weeks
66 Weeks
The proportion of subjects who experience virological failure throughout the study.
Time Frame: 66 Weeks
66 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral resistance analysis at baseline and throughout the study.
Time Frame: 66 Weeks
The miR-122 seed sites in HCV RNA from subjects at baseline and following viral breakthrough or relapse will be subjected to genotypic sequence analysis.
66 Weeks
Plasma pharmacokinetics (AUC, Cmax, tmax) for miravirsen, telaprevir, and ribavirin levels will be determined.
Time Frame: 31 Weeks
A single sample will be collected at select study visits for all subjects through Week 31. A subset of subjects will participate in extended PK sampling for up to 5 hours at select study visits and for up to 24 hours after the last dose of miravirsen.
31 Weeks
Urine pharmacokinetics for miravirsen levels will be determined.
Time Frame: Up to 16 Weeks
Urine pharmacokinetics (AUC, Cmax, tmax) for miravirsen levels will be measured in a subset of subjects for up to 24 hours after the last dose of miravirsen.
Up to 16 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santaris Pharma A/S

Investigators

  • Study Director: Michael Hodges, MD, Santaris Pharma A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

June 3, 2013

First Submitted That Met QC Criteria

June 5, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Estimate)

November 18, 2014

Last Update Submitted That Met QC Criteria

November 17, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPC3649-205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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