Status:
COMPLETED
Safety and Efficacy Study of Single Doses of TT-034 in Patients With Chronic Hepatitis C
Lead Sponsor:
Tacere Therapeutics, Inc.
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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. S...
Detailed Description
This is a first-time use of a method of therapy designed to transfer anti-HCV genetic sequences into the hepatocytes of subjects infected with HCV. The anti-HCV sequences will be comprised of three di...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- Evidence of autoimmune disease or pre-existing autoimmune or antibody-mediated diseases
- Use of immunosuppressive medications within 6 months before the entry into this study, except for inhaled or topical corticosteroids
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01899092
Start Date
January 1 2014
End Date
November 1 2016
Last Update
November 30 2016
Active Locations (4)
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1
UCSD Antiviral Research Center
San Diego, California, United States, 92103
2
Duke Clinical Research Institute
Durham, North Carolina, United States, 27710
3
The Liver Institute at Methodist Dallas
Dallas, Texas, United States, 75203
4
The Texas Liver Institute
San Antonio, Texas, United States, 78215