Back to resultsA Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection
Primary Purpose
Hepatitis C Viral Infection, Chronic Hepatitis C, Hepatitis C (HCV)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Faldaprevir
TD-6450
Ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Viral Infection
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus, HIV-1 or HIV-2
Sites / Locations
- Southern California Research Center
- Bach and Godofsky Infectious Diseases
- Gastro One
- Auckland Clinical Studies
- Dunedin Hospital
- Waikato Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Arm Description
12 weeks of Faldaprevir plus TD-6450 plus Ribavirin
12 weeks of Faldaprevir plus TD-6450
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02716428
Brief Title
A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection
Official Title
A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Faldaprevir and TD 6450 Alone and in Combination With Other Antivirals for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 1 Hepatitis C Virus
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trek Therapeutics, PBC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
A study to evaluate the safety and effect of treatment with experimental antiviral drugs alone or in combination with ribavirin in treatment-naïve participants with genotype 1b hepatitis C infection. The study will test the safety and anti-viral activity of two regimens administered for a duration of 12 weeks. Secondary objectives of this study are to determine the pharmacokinetics of the study drugs when co-administered, and to evaluate HCV RNA kinetics during treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Viral Infection, Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
12 weeks of Faldaprevir plus TD-6450 plus Ribavirin
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
12 weeks of Faldaprevir plus TD-6450
Intervention Type
Drug
Intervention Name(s)
Faldaprevir
Other Intervention Name(s)
BI 201335
Intervention Type
Drug
Intervention Name(s)
TD-6450
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Ribasphere®
Primary Outcome Measure Information:
Title
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
Time Frame
Post Treatment Week 12
Secondary Outcome Measure Information:
Title
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)
Time Frame
Post Treatment Weeks 2 to 8
Title
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
Time Frame
Randomization through End of Study, up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Infection with hepatitis B virus (HBV) or human immunodeficiency virus, HIV-1 or HIV-2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ed Gane, MD
Organizational Affiliation
Auckland Clinical Studies Ltd
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tarek Hassanein, MD
Organizational Affiliation
Southern California Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Bach and Godofsky Infectious Diseases
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Auckland Clinical Studies
City
Auckland
Country
New Zealand
Facility Name
Dunedin Hospital
City
Dunedin
Country
New Zealand
Facility Name
Waikato Hospital
City
Waikato
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection
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