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

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ClinicalTrials.gov Identifier: NCT01872936
Recruitment Status : Unknown
Verified November 2014 by Santaris Pharma A/S.
Recruitment status was:  Active, not recruiting
First Posted : June 7, 2013
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Santaris Pharma A/S

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.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Miravirsen Drug: Telaprevir Drug: Ribavirin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2013
Estimated Primary Completion Date : January 2015
Estimated Study Completion Date : January 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Miravirsen
Other Names:
  • SPC3649
  • Miravirsen sodium

Drug: Telaprevir
Other Name: Incivek

Drug: Ribavirin
Other Name: Copegus

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.
Drug: Miravirsen
Other Names:
  • SPC3649
  • Miravirsen sodium

Drug: Telaprevir
Other Name: Incivek

Drug: Ribavirin
Other Name: Copegus




Primary Outcome Measures :
  1. The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy. [ Time Frame: 42 weeks ]

Secondary Outcome Measures :
  1. The proportion of subjects with undetectable HCV RNA levels at end of treatment. [ Time Frame: 18 weeks ]
  2. The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy. [ Time Frame: 66 Weeks ]
  3. Change in HCV RNA levels from baseline throughout the study. [ Time Frame: 66 Weeks ]
  4. The proportion of subjects who experience virological failure throughout the study. [ Time Frame: 66 Weeks ]

Other Outcome Measures:
  1. Viral resistance analysis at baseline and throughout the study. [ Time Frame: 66 Weeks ]
    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.

  2. Plasma pharmacokinetics (AUC, Cmax, tmax) for miravirsen, telaprevir, and ribavirin levels will be determined. [ Time Frame: 31 Weeks ]
    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.

  3. Urine pharmacokinetics for miravirsen levels will be determined. [ Time Frame: Up to 16 Weeks ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872936


Locations
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United States, Texas
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Research Specialists of Texas
Houston, Texas, United States, 77030
Puerto Rico
Fundacion de Investigacion de Diego
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Santaris Pharma A/S
Investigators
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Study Director: Michael Hodges, MD Santaris Pharma A/S

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Responsible Party: Santaris Pharma A/S
ClinicalTrials.gov Identifier: NCT01872936     History of Changes
Other Study ID Numbers: SPC3649-205
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferons
Ribavirin
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs