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Trial record 92 of 382 for:    IFNA2 AND RBV AND genotype

Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01727934
Recruitment Status : Unknown
Verified January 2014 by Santaris Pharma A/S.
Recruitment status was:  Active, not recruiting
First Posted : November 16, 2012
Last Update Posted : January 6, 2014
Information provided by (Responsible Party):
Santaris Pharma A/S

Brief Summary:
The purpose of this open-label study is to assess the safety, antiviral activity, and pharmacokinetics of 9 subcutaneous injections of miravirsen monotherapy (5 weekly doses over 5 weeks, followed by a further 4 doses once every other week over 7 weeks) over a total of 12 weeks of treatment. The subjects enrolled in this study are chronically infected with HCV genotype 1 and are null responders to treatment with peg IFNα/RBV therapy.

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Miravirsen sodium Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Open-Label, Clinical Trial of Miravirsen Sodium in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C (CHC) Virus Genotype 1 Infection
Study Start Date : November 2012
Estimated Primary Completion Date : January 2014
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Miravirsen sodium
Miravirsen will be dosed as single subcutaneous injections. Subjects will receive 5 weekly doses at 7 mg/kg then 4 every other week doses at 5 mg/kg.
Drug: Miravirsen sodium
Subcutaneous injection
Other Name: SPC3649

Primary Outcome Measures :
  1. The proportion of subjects with sustained virological response 24 weeks after the end of therapy. [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy. [ Time Frame: 60 weeks ]
  2. The proportion of subjects with undetectable HCV RNA levels at the end of treatment. [ Time Frame: 12 weeks ]
  3. Change in HCV RNA levels from baseline throughout the study. [ Time Frame: 60 weeks ]
  4. The proportion of subjects who experience virological failure throughout the study. [ Time Frame: 60 weeks ]
  5. Safety will be assessed by evaluation of adverse events, physical examinations, vital signs, 12-lead ECGs, and laboratory assessments (clinical chemistry, hematology, urinalysis). [ Time Frame: 60 weeks ]

Other Outcome Measures:
  1. Viral resistance analysis at baseline and throughout the study. [ Time Frame: 60 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 [ Time Frame: 28 weeks ]
    Plasma PK for miravirsen levels will be determined for up to 2 hours post-dose on Day 1, up to 24 hours post-dose on Days 29 and 84, and pre-dose for all other treatment period visits. Additionally, plasma PK will be evaluated at all follow-up visits through Week 28.

  3. Urine pharmacokinetics [ Time Frame: Up to 24 hours post-dose on Day 29 and Day 84 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of chronic hepatitis C
  • HCV genotype 1
  • BMI 18-38 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 identifier (NCT number): NCT01727934

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Puerto Rico
Fundacion de Investigation de Diego
San Juan, Puerto Rico, 00927
Sponsors and Collaborators
Santaris Pharma A/S
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Principal Investigator: Maribel Rodriguez-Torres, MD Fundacion de Investgacion de Diego

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Responsible Party: Santaris Pharma A/S Identifier: NCT01727934     History of Changes
Other Study ID Numbers: SPC3649-207
First Posted: November 16, 2012    Key Record Dates
Last Update Posted: January 6, 2014
Last Verified: January 2014
Keywords provided by Santaris Pharma A/S:
miR-122 antagonist
host factor
Chronic hepatitis C
Hepatitis C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs