Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C

Santaris Pharma A/S10 enrolled

Overview

The purpose of this open-label study is to assess the safety, antiviral activity, and pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over 5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of 12 weeks of treatment. The subjects enrolled in this study are chronically infected with HCV genotype 1 and are null responders to treatment with peg IFNα/RBV therapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C

Interventions

Miravirsen sodiumDRUG

Subcutaneous injection

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of chronic hepatitis C * HCV genotype 1 * BMI 18-38 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

Locations (1)

Fundacion de Investigation de Diego

San Juan, Puerto Rico

Outcomes

Primary Outcomes

The proportion of subjects with sustained virological response 24 weeks after the end of therapy.

Time frame: 36 weeks

Secondary Outcomes

The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy.

Time frame: 60 weeks

The proportion of subjects with undetectable HCV RNA levels at the end of treatment.

Time frame: 12 weeks

Change in HCV RNA levels from baseline throughout the study.

Time frame: 60 weeks

The proportion of subjects who experience virological failure throughout the study.

Time frame: 60 weeks

Safety will be assessed by evaluation of adverse events, physical examinations, vital signs, 12-lead ECGs, and laboratory assessments (clinical chemistry, hematology, urinalysis).

Time frame: 60 weeks

Data from ClinicalTrials.gov

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