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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Santaris Pharma A/S
ClinicalTrials.gov Identifier:
NCT01727934
First received: November 12, 2012
Last updated: January 3, 2014
Last verified: January 2014

November 12, 2012
January 3, 2014
November 2012
January 2014   (final data collection date for primary outcome measure)
The proportion of subjects with sustained virological response 24 weeks after the end of therapy. [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01727934 on ClinicalTrials.gov Archive Site
  • The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects with undetectable HCV RNA levels at the end of treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change in HCV RNA levels from baseline throughout the study. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • The proportion of subjects who experience virological failure throughout the study. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
  • Viral resistance analysis at baseline and throughout the study. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
    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.
  • Plasma pharmacokinetics [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    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.
  • Urine pharmacokinetics [ Time Frame: Up to 24 hours post-dose on Day 29 and Day 84 ] [ Designated as safety issue: No ]
  • Viral resistance analysis at baseline and throughout the study. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • Plasma pharmacokinetics [ Time Frame: 28 weeks ] [ Designated as safety issue: No ]
    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.
  • Urine pharmacokinetics [ Time Frame: Up to 24 hours post-dose on Day 29 and Day 84 ] [ Designated as safety issue: No ]
 
Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C
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

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C
Drug: Miravirsen sodium
Subcutaneous injection
Other Name: SPC3649
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.
Intervention: Drug: Miravirsen sodium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
April 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico
 
NCT01727934
SPC3649-207
No
Santaris Pharma A/S
Santaris Pharma A/S
Not Provided
Principal Investigator: Maribel Rodriguez-Torres, MD Fundacion de Investgacion de Diego
Santaris Pharma A/S
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP