NCT02716428

Brief Summary

Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in treatment-naïve participants with genotype 1b hepatitis C virus (HCV) infection.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2016

Shorter than P25 for phase_2

Geographic Reach
2 countries

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

First Submitted

Initial submission to the registry

March 9, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 23, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 17, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

March 9, 2016

Last Update Submit

October 13, 2017

Conditions

Hepatitis C Viral InfectionChronic Hepatitis CHepatitis C (HCV)Hepatitis C Genotype 1

Outcome Measures

Primary Outcomes (1)

  • Percentage of subjects achieving 12-week sustained virologic response following treatment with 2 direct acting anti-virals with and without ribavirin in Genotype 1b Hepatitis C infected adults

    Post Treatment Week 12

Secondary Outcomes (2)

  • 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 with and without ribavirin)

    Post Treatment Weeks 2 to 8

  • Safety as determined by the incidence of serious adverse events, Grade 3 or 4 adverse events and laboratory abnormalities, and discontinuations due to adverse events

    Randomization through End of Study, up to 24 weeks

Study Arms (2)

Cohort 1

EXPERIMENTAL

12 weeks of Faldaprevir plus TD-6450 plus Ribavirin

Drug: FaldaprevirDrug: TD-6450Drug: Ribavirin

Cohort 2

EXPERIMENTAL

12 weeks of Faldaprevir plus TD-6450

Drug: FaldaprevirDrug: TD-6450

Interventions

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

Eligibility Criteria

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

You may qualify if:

  • Chronic genotype 1b 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 (kilopascals)
  • A non-invasive test measuring liver scarring (FibroSure®) score ≤ 0.48 and AST (aspartate aminotransferase):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 (6)

Southern California Research Center

Coronado, California, 92118, United States

Location

Bach and Godofsky Infectious Diseases

Bradenton, Florida, 34209, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Auckland Clinical Studies

Auckland, New Zealand

Location

Dunedin Hospital

Dunedin, New Zealand

Location

Waikato Hospital

Waikato, New Zealand

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

  • Ed Gane, MD

    Auckland Clinical Studies Ltd

    PRINCIPAL INVESTIGATOR

  • Tarek Hassanein, MD

    Southern California Research Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 23, 2016

Study Start

May 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

October 17, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(3)NZ(3)