Back to resultsMiravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C
Primary Purpose
Hepatitis C
Status
Unknown status
Phase
Phase 2
Locations
Puerto Rico
Study Type
Interventional
Intervention
Miravirsen sodium
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Antisense, miR-122 antagonist, host factor, Chronic hepatitis C, Hepatitis C
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
Sites / Locations
- Fundacion de Investigation de Diego
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Miravirsen sodium
Arm Description
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.
Outcomes
Primary Outcome Measures
The proportion of subjects with sustained virological response 24 weeks after the end of therapy.
Secondary Outcome Measures
The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy.
The proportion of subjects with undetectable HCV RNA levels at the end of treatment.
Change in HCV RNA levels from baseline throughout the study.
The proportion of subjects who experience virological failure throughout the study.
Safety will be assessed by evaluation of adverse events, physical examinations, vital signs, 12-lead ECGs, and laboratory assessments (clinical chemistry, hematology, urinalysis).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01727934
Brief Title
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
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
April 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santaris Pharma A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Antisense, miR-122 antagonist, host factor, Chronic hepatitis C, Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Miravirsen sodium
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Miravirsen sodium
Other Intervention Name(s)
SPC3649
Intervention Description
Subcutaneous injection
Primary Outcome Measure Information:
Title
The proportion of subjects with sustained virological response 24 weeks after the end of therapy.
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy.
Time Frame
60 weeks
Title
The proportion of subjects with undetectable HCV RNA levels at the end of treatment.
Time Frame
12 weeks
Title
Change in HCV RNA levels from baseline throughout the study.
Time Frame
60 weeks
Title
The proportion of subjects who experience virological failure throughout the study.
Time Frame
60 weeks
Title
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
Other Pre-specified Outcome Measures:
Title
Viral resistance analysis at baseline and throughout the study.
Description
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.
Time Frame
60 weeks
Title
Plasma pharmacokinetics
Description
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.
Time Frame
28 weeks
Title
Urine pharmacokinetics
Time Frame
Up to 24 hours post-dose on Day 29 and Day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maribel Rodriguez-Torres, MD
Organizational Affiliation
Fundacion de Investgacion de Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion de Investigation de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C
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