Clinical trial NCT01727934: Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatitis C
Keywords: Antisense
miR-122 antagonist
host factor
Chronic hepatitis C
Hepatitis C
Lead sponsor: Santaris Pharma A/S
Sponsor class: INDUSTRY
First posted: 2012-11-16
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The proportion of subjects with sustained virological response 24 weeks after the end of therapy.
timeFrame: 36 weeks
Secondary outcomes:
measure: The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy.
timeFrame: 60 weeks
measure: The proportion of subjects with undetectable HCV RNA levels at the end of treatment.
timeFrame: 12 weeks
measure: Change in HCV RNA levels from baseline throughout the study.
timeFrame: 60 weeks
measure: The proportion of subjects who experience virological failure throughout the study.
timeFrame: 60 weeks
measure: Safety will be assessed by evaluation of adverse events, physical examinations, vital signs, 12-lead ECGs, and laboratory assessments (clinical chemistry, hematology, urinalysis).
timeFrame: 60 weeks
Other outcomes:
measure: Viral resistance analysis at baseline and throughout the study.
timeFrame: 60 weeks
measure: Plasma pharmacokinetics
timeFrame: 28 weeks
measure: Urine pharmacokinetics
timeFrame: Up to 24 hours post-dose on Day 29 and Day 84
Locations:
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigation de Diego
Study officials:
affiliation: Fundacion de Investgacion de Diego
name: Maribel Rodriguez-Torres, MD
role: PRINCIPAL_INVESTIGATOR
References: