Long-Term Extension Study of Miravirsen Among Participants With Genotype 1 Chronic Hepatitis C (CHC) Who Have Not Responded to Pegylated-Interferon Alpha Plus Ribavirin

October 30, 2017 updated by: Hoffmann-La Roche

Long-Term Extension to a Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin in Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection

Genotype 1 CHC participants from Study SPC3649-207 with null response to prior pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension study, designed to evaluate the long-term safety and efficacy after 12 weeks of miravirsen monotherapy. Due to the observational nature of the study, miravirsen will not be dosed as an investigational product.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10

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

      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion de Diego

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will enroll null responders with CHC genotype 1 virus infection who have participated in Study SPC3649-207.

Description

Inclusion Criteria:

  • Participants from Study SPC3649-207, including those who completed the study and those who discontinued or terminated the study early for any reason, or those who opted to receive other approved therapy for the treatment of hepatitis C virus (HCV) infection

Exclusion Criteria:

  • Participants who have received investigational drug therapy after discontinuation, termination, or completion of Study SPC3649-207

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Study Population
Participants who previously received 12 weeks of miravirsen monotherapy in Study SPC3649-207 will complete up to 36 months of safety and efficacy follow-up without investigational treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events
Time Frame: Up to 36 months
Up to 36 months
Incidence of sustained virologic response (SVR)
Time Frame: 48 weeks after end of treatment (EOT)
48 weeks after end of treatment (EOT)
Change from Baseline in HCV ribonucleic acid (RNA) level
Time Frame: Up to 36 months
Up to 36 months
Incidence of HCV resistance
Time Frame: Up to 36 months
Up to 36 months

Collaborators and Investigators

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

Collaborators

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 (Actual)

August 2, 2013

Primary Completion (Actual)

January 13, 2017

Study Completion (Actual)

January 13, 2017

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 23, 2015

First Posted (Estimate)

July 24, 2015

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

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.

Clinical Trials on Chronic Hepatitis C

3
Subscribe