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

S

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)

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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