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

Hoffmann-La Roche10 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Hepatitis C

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Fundacion de Investigacion de Diego

San Juan, Puerto Rico

Outcomes

Primary Outcomes

Incidence of adverse events

Time frame: Up to 36 months

Incidence of sustained virologic response (SVR)

Time frame: 48 weeks after end of treatment (EOT)

Change from Baseline in HCV ribonucleic acid (RNA) level

Time frame: Up to 36 months

Incidence of HCV resistance

Time frame: Up to 36 months

Data from ClinicalTrials.gov

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