NCT01726946

Brief Summary

A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135 in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C

Trial Health

87
On Track

Trial Health Score

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

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

6 active sites

Status
completed

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
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

April 16, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

November 7, 2012

Last Update Submit

March 27, 2015

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis CHCVCHC

Outcome Measures

Primary Outcomes (1)

  • The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments

    Up to 52 weeks

Secondary Outcomes (8)

  • The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)

    16 weeks

  • The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)

    24 weeks

  • The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)

    36 weeks

  • The proportion of subjects who have virologic relapse

    Up to 52 weeks

  • Viral kinetics, as determined at different time points by the proportion of subjects who achieve: -Undetectable HCV RNA -<LLOQ HCV RNA

    Up to 64 weeks

  • +3 more secondary outcomes

Study Arms (2)

VX-135 High Dose with ribavirin

EXPERIMENTAL

12 weeks of a high dose of VX-135 in combination with ribavirin

Drug: VX-135Drug: ribavirin

VX-135 Low Dose with ribavirin

EXPERIMENTAL

12 weeks of a low dose of VX-135 in combination with ribavirin

Drug: VX-135Drug: ribavirin

Interventions

VX-135DRUG

12 weeks of VX-135

VX-135 High Dose with ribavirinVX-135 Low Dose with ribavirin
ribavirinDRUG

12 weeks of ribavirin

VX-135 High Dose with ribavirinVX-135 Low Dose with ribavirin

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects (male and female) must be between the ages of 18 and 60 years at screening
  • Subjects must have genotype 1 Chronic Hepatitis C
  • Subjects must be treatment naïve
  • Subjects must have laboratory values at screening within limits as specified by the protocol

You may not qualify if:

  • Evidence of cirrhosis
  • Female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study
  • Any other cause of significant liver disease in addition to hepatitis C
  • Human immunodeficiency virus -1 or -2
  • Diagnosis of or suspected hepatocellular carcinoma
  • History of organ transplant, with the exception of corneal transplants and skin grafts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

California

La Jolla, California, United States

Location

Florida

Orlando, Florida, United States

Location

Georgia

Marietta, Georgia, United States

Location

Tennessee

Germantown, Tennessee, United States

Location

Texas

Arlington, Texas, United States

Location

Texas

Houston, Texas, United States

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

Ribavirin

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

  • Medical Monitor

    Vertex Pharmaceuticals Incorporated

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 15, 2012

Study Start

November 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 16, 2015

Record last verified: 2015-03

Locations

US(6)