Clinical trial NCT01872936: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Lead sponsor: Santaris Pharma A/S
Sponsor class: INDUSTRY
First posted: 2013-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.
timeFrame: 42 weeks
Secondary outcomes:
measure: The proportion of subjects with undetectable HCV RNA levels at end of treatment.
timeFrame: 18 weeks
measure: The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.
timeFrame: 66 Weeks
measure: Change in HCV RNA levels from baseline throughout the study.
timeFrame: 66 Weeks
measure: The proportion of subjects who experience virological failure throughout the study.
timeFrame: 66 Weeks
Other outcomes:
measure: Viral resistance analysis at baseline and throughout the study.
timeFrame: 66 Weeks
measure: Plasma pharmacokinetics (AUC, Cmax, tmax) for miravirsen, telaprevir, and ribavirin levels will be determined.
timeFrame: 31 Weeks
measure: Urine pharmacokinetics for miravirsen levels will be determined.
timeFrame: Up to 16 Weeks
Locations:
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Santaris Pharma A/S
name: Michael Hodges, MD
role: STUDY_DIRECTOR
References: