NCT01872936

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.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2013

Geographic Reach
2 countries

3 active sites

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

June 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 3, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

November 18, 2014

Status Verified

November 1, 2014

Enrollment Period

1.6 years

First QC Date

June 3, 2013

Last Update Submit

November 17, 2014

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

  • The proportion of subjects with a Sustained Virological Response at 24 weeks after the end of therapy.

    42 weeks

Secondary Outcomes (4)

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

    18 weeks

  • The proportion of subjects with a Sustained Virological Response at 12 and 48 weeks after the end of therapy.

    66 Weeks

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

    66 Weeks

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

    66 Weeks

Other Outcomes (3)

  • Viral resistance analysis at baseline and throughout the study.

    66 Weeks

  • Plasma pharmacokinetics (AUC, Cmax, tmax) for miravirsen, telaprevir, and ribavirin levels will be determined.

    31 Weeks

  • Urine pharmacokinetics for miravirsen levels will be determined.

    Up to 16 Weeks

Study Arms (2)

Miravirsen every other week dosing

OTHER

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: MiravirsenDrug: TelaprevirDrug: Ribavirin

Miravirsen monthly dosing

OTHER

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: MiravirsenDrug: TelaprevirDrug: Ribavirin

Interventions

MiravirsenDRUG
Also known as: SPC3649, Miravirsen sodium
Miravirsen every other week dosingMiravirsen monthly dosing
TelaprevirDRUG
Also known as: Incivek
Miravirsen every other week dosingMiravirsen monthly dosing
RibavirinDRUG
Also known as: Copegus
Miravirsen every other week dosingMiravirsen monthly dosing

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of chronic hepatitis C genotype 1 infection
  • BMI 18 and 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 (3)

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

Research Specialists of Texas

Houston, Texas, 77030, United States

Location

Fundacion de Investigacion de Diego

San Juan, 00927, Puerto Rico

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

miravirsentelaprevirRibavirin

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Michael Hodges, MD

    Santaris Pharma A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2013

First Posted

June 7, 2013

Study Start

June 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

November 18, 2014

Record last verified: 2014-11

Locations

US(2)PR(1)