NCT01727934UnknownPhase 2
A Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection
Santaris Pharma A/S1 site in 1 country10 target enrollmentStarted: November 2012Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- The proportion of subjects with sustained virological response 24 weeks after the end of therapy.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Miravirsen sodium
Experimental
Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg then 4 every other week doses at 5 mg/kg.
Intervention: Miravirsen sodium (Drug)
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.(60 weeks)
- 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)
- 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 who experience virological failure throughout the study.(60 weeks)
Investigators
Study Sites (1)
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