Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection
NCT ID: NCT01872936
Last Updated: 2014-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
20 participants
INTERVENTIONAL
2013-06-30
2015-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Miravirsen every other week dosing
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
Telaprevir
Ribavirin
Miravirsen monthly dosing
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.
Miravirsen
Telaprevir
Ribavirin
Interventions
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Miravirsen
Telaprevir
Ribavirin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI 18 and 38 kg/m2
* Null responder to pegylated interferon alpha and ribavirin
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Santaris Pharma A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Hodges, MD
Role: STUDY_DIRECTOR
Santaris Pharma A/S
Locations
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The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States
Research Specialists of Texas
Houston, Texas, United States
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Countries
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Other Identifiers
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SPC3649-205
Identifier Type: -
Identifier Source: org_study_id