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TT-034

Phase 1

Hepatitis C | Small molecule | Infectious Disease |Benitec Biopharma Inc.|Trials Updated: Nov 30, 2016

TT-034 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

TT-034 clinical trials

TT-034 · 1 trial · 1 indication

Phase 1 1
NCT01899092Safety and Efficacy Study of Single Doses of TT-034 in Patients With Chronic Hepatitis CHepatitis C
COMPLETED9 Analytics
PHASE1COMPLETED
Safety and Efficacy Study of Single Doses of TT-034 in Patients With Chronic Hepatitis C
Hepatitis CUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective is to assess the safety and tolerability of single escalating doses of TT-034 administered IV as a single infusion to subjects with CHC.
6 months

Secondary Endpoints

To assess the activity of TT-034 on the viral load of subjects with CHC receiving single escalating doses of TT-034
6 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Escalating Dose of TT-034EXPERIMENTALThe study contains one dose escalation arm with active drug.

Interventions

NameTypeDescription
TT-034DRUGThe study drug will be given as a single dose IV infusion on Day 1. 5 different dose levels corresponding to the 5 cohorts of the study will be given.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: Subjects must a history of chronic HCV infection defined as documented HCV genotype 1 infection for at least 6 months. * Subjects must have: 1. Documented failure to respond to prior treatment or relapse with a combination of peg-interferon (peg-IFN), ribavirin (RBV), and ei...

Countries:United States
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Competitive Landscape -Hepatitis C 13 trials

Top 1 of 4 competitors

CompanyTickerTrialsLead PhaseDrugs
Atea Pharmaceuticals, Inc.AVIR2PHASE3Bemnifosbuvir-Ruzasvir
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Frequently asked questions about TT-034

What is TT-034?

TT-034 is an investigational small molecule developed by Benitec Biopharma Inc. for the treatment of chronic hepatitis C. It was studied in a single Phase 1 clinical trial and is not an approved therapy. The program was evaluated in patients with chronic hepatitis C virus infection in the United States.

What is TT-034 used for in hepatitis C?

TT-034 was being developed as a treatment for chronic hepatitis C, an infectious disease of the liver caused by the hepatitis C virus. Its only clinical study enrolled patients with chronic hepatitis C to assess safety and efficacy of single doses. It is investigational and has not been approved for any use.

Who makes TT-034?

TT-034 is developed by Benitec Biopharma Inc., which trades under the ticker BNTC. The company sponsored the Phase 1 study of the drug in patients with chronic hepatitis C. Benitec Biopharma is the sole developer named for this asset.

What phase is TT-034 in?

TT-034 is in Phase 1 development. It has completed one Phase 1 clinical trial and has no active trials. The drug is investigational and has not been approved by the FDA or any other regulatory agency for the treatment of hepatitis C.

What clinical trials is TT-034 in?

TT-034 was evaluated in one completed Phase 1 trial, NCT01899092, titled Safety and Efficacy Study of Single Doses of TT-034 in Patients With Chronic Hepatitis C. The study enrolled 9 patients aged 18 years and older in the United States. It was an uncontrolled, non-randomized, open-label study.