The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02716428




Registration number
NCT02716428
Ethics application status
Date submitted
9/03/2016
Date registered
23/03/2016
Date last updated
17/10/2017

Titles & IDs
Public title
A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection
Scientific 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
Secondary ID [1] 0 0
TRK-450-0203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Viral Infection 0 0
Chronic Hepatitis C 0 0
Hepatitis C (HCV) 0 0
Hepatitis C Genotype 1 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Faldaprevir
Treatment: Drugs - TD-6450
Treatment: Drugs - Ribavirin

Experimental: Cohort 1 - 12 weeks of Faldaprevir plus TD-6450 plus Ribavirin

Experimental: Cohort 2 - 12 weeks of Faldaprevir plus TD-6450


Treatment: Drugs: Faldaprevir


Treatment: Drugs: TD-6450


Treatment: Drugs: Ribavirin


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Post Treatment Week 12
Secondary outcome [1] 0 0
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)
Timepoint [1] 0 0
Post Treatment Weeks 2 to 8
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Randomization through End of Study, up to 24 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus, HIV-1 or HIV-2

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland
Country [5] 0 0
New Zealand
State/province [5] 0 0
Dunedin
Country [6] 0 0
New Zealand
State/province [6] 0 0
Waikato

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Trek Therapeutics, PBC
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/show/NCT02716428
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ed Gane, MD
Address 0 0
Auckland Clinical Studies Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications