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

Purpose

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	Intervention	Phase
Hepatitis C	Drug: Miravirsen sodium	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin Interferon Alfa-2a Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Santaris Pharma A/S:

Primary Outcome Measures:

The proportion of subjects with sustained virological response 24 weeks after the end of therapy. [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Other Outcome Measures:

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 ]

Estimated Enrollment:	10
Study Start Date:	November 2012
Estimated Study Completion Date:	February 2014
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	21 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727934

Locations

Puerto Rico
Fundacion de Investigation de Diego	Recruiting
San Juan, Puerto Rico, 00927
Contact: Roberto Galarza 787-722-1248
Contact: Isamarie Alma 787-722-1248
Principal Investigator: Maribel Rodriguez-Torres, MD

Sponsors and Collaborators

Santaris Pharma A/S

Investigators

Principal Investigator:

Maribel Rodriguez-Torres, MD

Fundacion de Investgacion de Diego

More Information

No publications provided

Responsible Party:	Santaris Pharma A/S
ClinicalTrials.gov Identifier:	NCT01727934 History of Changes
Other Study ID Numbers:	SPC3649-207
Study First Received:	November 12, 2012
Last Updated:	November 16, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Santaris Pharma A/S:

Antisense
miR-122 antagonist
host factor
Chronic hepatitis C
Hepatitis C

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a

Interferons
Ribavirin
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013