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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02508090

Enrollment

Registered

2015-07-24

Start date

2013-08-02

Completion date

2017-01-13

Last updated

2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Puerto Rico

Outcome results