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

Santaris Pharma

Status and phase: Unknown; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Ribavirin; Drug: Miravirsen; Drug: Telaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01872936

SPC3649-205

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Miravirsen every other week dosing

Other group

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.

Treatment:

Drug: Telaprevir

Drug: Miravirsen

Drug: Ribavirin

Miravirsen monthly dosing

Other group

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.

Treatment:

Drug: Telaprevir

Drug: Miravirsen

Drug: Ribavirin