Safety and Efficacy Study of Single Doses of TT-034 in Patients With Chronic Hepatitis C

Completed · Phase 1/Phase 2

Conditions studied: Hepatitis C

In brief

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 Once the study drug is given, it cannot be withdrawn.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.

Key facts

Study ID

NCT01899092

Run by

Tacere Therapeutics, Inc.

People needed

9

Starts

2014-01-01

Expected to finish

2016-11-01

Last updated by the study team

2016-11-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• Renal impairment
• Hospitalization for liver disease within 60 days of Screening
• Use of drugs of abuse in the prior 3 months
• Other concomitant disease or condition likely to significantly decrease life expectancy or cancer
• Treatment with an investigational drug within 6 months preceding the first dose of trial medication
• Received an AAV vector previously or any other gene transfer agent in the previous 6 months
• History of cardiac abnormalities, as assessed at the Screening Visit
• Twelve-lead ECG demonstrating QTcB > 465 ms at Screening
• Chronic hepatic diseases
• Evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurologic, or allergic diseases.

Where it is running

• UCSD Antiviral Research Center — San Diego, California, United States
• Duke Clinical Research Institute — Durham, North Carolina, United States
• The Liver Institute at Methodist Dallas — Dallas, Texas, United States
• The Texas Liver Institute — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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