A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection
Completed · Phase 2
Conditions studied: Hepatitis C Viral Infection, Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1
In brief
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.
Key facts
- Study ID
- NCT02716428
- Run by
- Trek Therapeutics, PBC
- People needed
- 25
- Starts
- 2016-05-01
- Expected to finish
- 2017-09-01
- Last updated by the study team
- 2017-10-17
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Southern California Research Center — Coronado, California, United States
- Bach and Godofsky Infectious Diseases — Bradenton, Florida, United States
- Gastro One — Germantown, Tennessee, United States
- Auckland Clinical Studies — Auckland, New Zealand
- Dunedin Hospital — Dunedin, New Zealand
- Waikato Hospital — Waikato, New Zealand
Full record on ClinicalTrials.gov
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