NCT01899092

Brief Summary

The study is a first in man, dose escalation study that will measure the safety and efficacy of TT-034 in the treatment of patients with chronic hepatitis C. The study is divided into 5 dose levels. Subjects will be given a single dose delivered by IV infusion. The subjects will be monitored and the data analyzed. After a set time, between 6 and 10 weeks depending on the dose level, the next set of subjects will be dosed. The study drug is a gene therapy treatment that produces molecules that destroy the Hepatitis C virus (HCV) in infected cells. Once the study drug is given, it cannot be withdrawn. Additionally, once an individual receives a dose, he or she will not be able to receive a second dose, but will remain eligible to receive most other HCV treatments.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2014

Typical duration for phase_1

Geographic Reach
1 country

4 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

July 8, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

2.7 years

First QC Date

July 8, 2013

Last Update Submit

November 28, 2016

Conditions

Hepatitis C

Keywords

Genotype 1Chronic Hepatitis CCHCHCVHepatitisRNAishRNAddRNAiAAV8AAVAdeno-associated virusAdeno-associated viral vectors

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To assess the activity of TT-034 on the viral load of subjects with CHC receiving single escalating doses of TT-034

    6 months

Other Outcomes (5)

  • To determine the maximum tolerable dose or the optimal efficacy dose (whichever comes first)

    6 months

  • To determine the viral load

    6 months

  • To assess the presence of viral escape mutants in subjects with detectable viral load after receiving TT-034

    6 months

  • +2 more other outcomes

Study Arms (1)

Escalating Dose of TT-034

EXPERIMENTAL

The study contains one dose escalation arm with active drug.

Drug: TT-034

Interventions

TT-034DRUG

The 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.

Escalating Dose of TT-034

Eligibility Criteria

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

You may qualify if:

  • Subjects must a history of chronic HCV infection defined as documented HCV genotype 1 infection for at least 6 months.
  • Subjects must have:
  • Documented failure to respond to prior treatment or relapse with a combination of peg-interferon (peg-IFN), ribavirin (RBV), and either boceprevir or telaprevir, OR a combination of peg-IFN and ribavirin or
  • Subject is ineligible or unwilling to receive a combination of peg-IFN, RBV, and either boceprevir or telaprevir.
  • Female subjects have to be of non-childbearing potential, defined as meeting any of the following criteria:
  • Female subjects over the age 60.
  • Female subjects aged 45-60 years old must be amenorrhoeic for at least 2 years and must have serum follicle stimulating hormone (FSH) levels \> 30 IU/L.
  • Female subjects with hysterectomy or bilateral oophorectomy. All female subjects must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.
  • Male subjects and their partners must be willing to comply with the following requirements to use 2 methods of effective contraception: Male subjects with a vasectomy must use a condom. Without a vasectomy, male subjects must use a condom. The female must be sterile or willing to use an additional form of contraception.
  • Baseline HCV RNA level of \> 100,000 IU/mL and:
  • No evidence of cirrhosis at Screening
  • At least 3 months since prior therapy for HCV
  • A willingness to enroll in a 5 year follow-up safety study

You may not qualify if:

  • Body mass index \< 18.5 or \> 30
  • Total body weight \> 80 KG
  • Female subjects of childbearing potential (including females with tubal ligation) or women who are pregnant or nursing
  • Male subjects who are unwilling to provide the required semen samples
  • Presence of nAb levels to AAV8 that abrogate AAV8 transduction
  • Severe Liver disease
  • Hepatocellular carcinoma (HCC) or suspicion of HCC
  • Coronary artery disease
  • Platelet count of \< 150 x 109/L or Creatinine ≥ 1.5 mg/dL at Screening
  • Hypertension with systolic blood pressure consistently ≥ 130 mmHg or diastolic blood pressure consistently ≥ 90 mmHg
  • Screening examinations indicative of possible occult malignancy unless cancer has been excluded
  • Family history of colon cancer in any first-degree relative unless ruled out by colonoscopy
  • Positive for human immunodeficiency virus 1 (HIV1) or HIV2 antibody
  • Co-infection with hepatitis B virus
  • History of autoimmune disease
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UCSD Antiviral Research Center

San Diego, California, 92103, United States

Location

Duke Clinical Research Institute

Durham, North Carolina, 27710, United States

Location

The Liver Institute at Methodist Dallas

Dallas, Texas, 75203, United States

Location

The Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Conditions

Hepatitis CHepatitis C, ChronicHepatitis

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsLiver DiseasesDigestive System DiseasesHepatitis, ChronicChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Suhy, PhD

    Tacere Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2013

First Posted

July 15, 2013

Study Start

January 1, 2014

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

November 30, 2016

Record last verified: 2016-11

Locations

US(4)