Back to resultsMiravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection
Primary Purpose
Hepatitis C, Chronic
Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Miravirsen
Telaprevir
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of chronic hepatitis C genotype 1 infection
- BMI 18 and 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
- The Liver Institute at Methodist Dallas Medical Center
- Research Specialists of Texas
- Fundacion de Investigacion de Diego
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Miravirsen every other week dosing
Miravirsen monthly dosing
Arm Description
Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 6 every other week doses at 5 mg/kg in combination with telaprevir and ribavirin.
Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 3 monthly doses at 7 mg/kg in combination with telaprevir and ribavirin.
Outcomes
Primary Outcome Measures
The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.
Secondary Outcome Measures
The proportion of subjects with undetectable HCV RNA levels at end of treatment.
The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.
Change in HCV RNA levels from baseline throughout the study.
The proportion of subjects who experience virological failure throughout the study.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01872936
Brief Title
Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection
Official Title
Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Combination With Telaprevir and Ribavirin in Null Responders to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Genotype 1 Infection
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
January 2015 (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, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Miravirsen every other week dosing
Arm Type
Other
Arm Description
Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 6 every other week doses at 5 mg/kg in combination with telaprevir and ribavirin.
Arm Title
Miravirsen monthly dosing
Arm Type
Other
Arm Description
Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg, then 3 monthly doses at 7 mg/kg in combination with telaprevir and ribavirin.
Intervention Type
Drug
Intervention Name(s)
Miravirsen
Other Intervention Name(s)
SPC3649, Miravirsen sodium
Intervention Type
Drug
Intervention Name(s)
Telaprevir
Other Intervention Name(s)
Incivek
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus
Primary Outcome Measure Information:
Title
The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.
Time Frame
42 weeks
Secondary Outcome Measure Information:
Title
The proportion of subjects with undetectable HCV RNA levels at end of treatment.
Time Frame
18 weeks
Title
The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.
Time Frame
66 Weeks
Title
Change in HCV RNA levels from baseline throughout the study.
Time Frame
66 Weeks
Title
The proportion of subjects who experience virological failure throughout the study.
Time Frame
66 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
66 Weeks
Title
Plasma pharmacokinetics (AUC, Cmax, tmax) for miravirsen, telaprevir, and ribavirin levels will be determined.
Description
A single sample will be collected at select study visits for all subjects through Week 31. A subset of subjects will participate in extended PK sampling for up to 5 hours at select study visits and for up to 24 hours after the last dose of miravirsen.
Time Frame
31 Weeks
Title
Urine pharmacokinetics for miravirsen levels will be determined.
Description
Urine pharmacokinetics (AUC, Cmax, tmax) for miravirsen levels will be measured in a subset of subjects for up to 24 hours after the last dose of miravirsen.
Time Frame
Up to 16 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of chronic hepatitis C genotype 1 infection
BMI 18 and 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
Michael Hodges, MD
Organizational Affiliation
Santaris Pharma A/S
Official's Role
Study Director
Facility Information:
Facility Name
The Liver Institute at Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Research Specialists of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
12. IPD Sharing Statement
Learn more about this trial
Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection
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