Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01872936
• Other study ID #: SPC3649-205
• Status: Active, not recruiting
• Phase: Phase 2
• First received: June 3, 2013
• Last updated: November 17, 2014
• Start date: June 2013
• Est. completion date: January 2015

Study information

• Verified date: November 2014
• Source: Santaris Pharma A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Miravirsen

• Telaprevir

• Ribavirin

Locations

Country	Name	City	State
Puerto Rico	Fundacion de Investigacion de Diego	San Juan
United States	The Liver Institute at Methodist Dallas Medical Center	Dallas	Texas
United States	Research Specialists of Texas	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Santaris Pharma A/S

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Viral resistance analysis at baseline and throughout the study.	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.	66 Weeks	No
Other	Plasma pharmacokinetics (AUC, Cmax, tmax) for miravirsen, telaprevir, and ribavirin levels will be determined.	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.	31 Weeks	No
Other	Urine pharmacokinetics for miravirsen levels will be determined.	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.	Up to 16 Weeks	No
Primary	The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.		42 weeks	No
Secondary	The proportion of subjects with undetectable HCV RNA levels at end of treatment.		18 weeks	No
Secondary	The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.		66 Weeks	No
Secondary	Change in HCV RNA levels from baseline throughout the study.		66 Weeks	No
Secondary	The proportion of subjects who experience virological failure throughout the study.		66 Weeks	No