NCT02593162

Brief Summary

Phase 2a study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 in combination with Ribavirin for a 12-week treatment duration in treatment-naïve participants with genotype 4 hepatitis C virus (HCV) infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

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

October 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

October 29, 2015

Last Update Submit

January 27, 2017

Conditions

Hepatitis C Viral InfectionChronic Hepatitis CHepatitis C (HCV)Hepatitis C Genotype 4

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects achieving 12-week sustained virologic response following treatment with 2 direct acting anti-virals and ribavirin in Genotype 4 Hepatitis C infected adults

    Post Treatment Week 12

Secondary Outcomes (2)

  • Percentage of subjects with virologic response at Week 12 (HCV RNA less than lower limit of quantitation at end of therapy with Faldaprevir plus TD-6450 plus ribavirin)

    Week 12

  • Percentage of subjects with virologic response 2, 4 and 8 weeks after treatment completion (HCV RNA less than lower limit of quantitation at 2, 4 and 8 weeks after end of therapy with Faldaprevir plus TD-6450 plus ribavirin)

    Post Treatment Weeks 2 to 8

Study Arms (2)

Group 1

EXPERIMENTAL

12 weeks of Faldaprevir plus low dose TD-6450 plus Ribavirin

Drug: FaldaprevirDrug: TD-6450Drug: Ribavirin

Group 2

EXPERIMENTAL

12 weeks of Faldaprevir plus high dose TD-6450 plus Ribavirin

Drug: FaldaprevirDrug: TD-6450Drug: Ribavirin

Interventions

FaldaprevirDRUG
Also known as: BI 201335
Group 1Group 2
TD-6450DRUG
Group 1Group 2
RibavirinDRUG
Also known as: Ribasphere®
Group 1Group 2

Eligibility Criteria

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

You may qualify if:

  • Chronic genotype 4 hepatitis C infection and HCV RNA ≥ 10\^4 IU/mL at screening
  • Hepatitis C virus treatment naive, defined as defined as having never received a direct acting anti-viral (DAA), and as having received ≤ 8 weeks of interferon ≥ 6 months prior to screening
  • Absence of cirrhosis as defined by one of the following:
  • A liver biopsy performed within 24 calendar months of Day 1 showing absence of cirrhosis
  • Transient elastography (FibroScan®) performed within 12 calendar months of Day 1 with a result of ≤ 12.5 kPa
  • A FibroSure® score ≤ 0.48 and AST:platelet ratio (APRI) ≤ 1 performed during screening

You may not qualify if:

  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus, HIV-1 or HIV-2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern California Research Center

Coronado, California, 92118, United States

Location

MeSH Terms

Conditions

Hepatitis C, ChronicHepatitis C

Interventions

faldaprevirRibavirin

Condition Hierarchy (Ancestors)

Blood-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

  • Tarek Hassanein, MD

    Southern California Research Center

    PRINCIPAL INVESTIGATOR

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

October 29, 2015

First Posted

October 30, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 30, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)