NCT01727934

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 16, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

January 6, 2014

Status Verified

January 1, 2014

Enrollment Period

1.2 years

First QC Date

November 12, 2012

Last Update Submit

January 3, 2014

Conditions

Hepatitis C

Keywords

AntisensemiR-122 antagonisthost factorChronic hepatitis CHepatitis C

Outcome Measures

Primary Outcomes (1)

  • The proportion of subjects with sustained virological response 24 weeks after the end of therapy.

    36 weeks

Secondary Outcomes (5)

  • The proportion of subjects with a sustained virological response 12 and 48 weeks after the end of therapy.

    60 weeks

  • The proportion of subjects with undetectable HCV RNA levels at the end of treatment.

    12 weeks

  • Change in HCV RNA levels from baseline throughout the study.

    60 weeks

  • The proportion of subjects who experience virological failure throughout the study.

    60 weeks

  • Safety will be assessed by evaluation of adverse events, physical examinations, vital signs, 12-lead ECGs, and laboratory assessments (clinical chemistry, hematology, urinalysis).

    60 weeks

Other Outcomes (3)

  • Viral resistance analysis at baseline and throughout the study.

    60 weeks

  • Plasma pharmacokinetics

    28 weeks

  • Urine pharmacokinetics

    Up to 24 hours post-dose on Day 29 and Day 84

Study Arms (1)

Miravirsen sodium

EXPERIMENTAL

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

Interventions

Miravirsen sodiumDRUG

Subcutaneous injection

Also known as: SPC3649
Miravirsen sodium

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic hepatitis C
  • HCV genotype 1
  • BMI 18-38 kg/m2
  • Null responder to pegylated interferon alpha and ribavirin

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundacion de Investigation de Diego

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Hepatitis CHepatitis C, Chronic

Interventions

miravirsen

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maribel Rodriguez-Torres, MD

    Fundacion de Investgacion de Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2012

First Posted

November 16, 2012

Study Start

November 1, 2012

Primary Completion

January 1, 2014

Study Completion

April 1, 2014

Last Updated

January 6, 2014

Record last verified: 2014-01

Locations

PR(1)