Hepatitis C
Conditions
Keywords
Antisense, miR-122 antagonist, host factor, Chronic hepatitis C, Hepatitis C
Brief summary
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.
Interventions
Subcutaneous injection
Sponsors
Santaris Pharma A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with sustained virological response 24 weeks after the end of therapy. | 36 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects with undetectable HCV RNA levels at the end of treatment. | 12 weeks |
| Change in HCV RNA levels from baseline throughout the study. | 60 weeks |
| The proportion of subjects who experience virological failure throughout the study. | 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). | 60 weeks |
| The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy. | 60 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| Urine pharmacokinetics | Up to 24 hours post-dose on Day 29 and Day 84 | — |
| Plasma pharmacokinetics | 28 weeks | Plasma PK for miravirsen levels will be determined for up to 2 hours post-dose on Day 1, up to 24 hours post-dose on Days 29 and 84, and pre-dose for all other treatment period visits. Additionally, plasma PK will be evaluated at all follow-up visits through Week 28. |
| Viral resistance analysis at baseline and throughout the study. | 60 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. |
Countries
Puerto Rico
Outcome results
None listed