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A phase II worldwide study of TG4040 in combination with the standard treatment for hepatitis C in treatment-naïve patients with chronic hepatitis C.

Conditions
Treatment of patients with chronic genotype 1 hepatitis C
MedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Registration Number
EUCTR2009-011121-13-DE
Lead Sponsor
TRANSGENE S.A.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
140
Inclusion Criteria

- Male or female patients, age =18 to = 70 years;
- Chronically infected patients with Hepatitis C virus Genotype 1 (1a or 1b) with detectable viremia (HCV RNA in blood) for more than 6 months and naïve to treatment;
- Patients must have compensated liver disease, with no history of ascites, jaundice, hepatic encephalopathy or bleeding from esophageal or gastric varices requiring beta-blockers;
- No histological evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 24 months prior to baseline; or on a FibroScan® performed within 6 months prior to treatment which indicates the absence of liver cirrhosis, i.e., stage < F4 (METAVIR) or 12 kPa; in case of no available results, a liver biopsy will be performed prior to treatment;
- All laboratory parameters must be grade 0 or 1 (as per CTCAE criteria) except for alanine amino-transferase (ALT), aspartate amino-transferase (AST), gamma glutamyl transferase (GGT) and alkaline phosphatase (ALP) for which a grade 2 will be allowed if stated non clinically significant;
- No co-infection with Human Immunodeficiency Virus (HIV) or hepatitis B virus (HBsAg positive);
- No intravenous (IV) drug or alcohol abuse;
- Serum thyroid stimulating hormone (TSH) levels within normal ranges, regardless of treatment with L-thyroxin;
- Normal electrocardiogram (ECG);
- Normal retinal examination (eye fundus) within last 12 months for diabetic patients or patients suffering from high blood pressure;
- Negative pregnancy test in women of childbearing potential (a woman who is two years post-menopausal or surgically sterile is not considered to be of childbearing potential);
- Female patients and female partners of male patients (if childbearing potency) must agree to use two effective methods of birth control during the study and for 6 months after the end of treatment. One of the methods needs to be a 'barrier' method (condom or diaphragm);
- Written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 139
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

- Prior treatment for hepatitis C;
- Malignancy within the last 5 years; except for patients with history of squamous cell skin cancer or basal cell skin cancer who will be enrolled, unless patients have a history of skin cancer at the vaccination site;
- Diagnosed or suspected hepatocellular carcinoma;
- History of psychiatric conditions including, but not limited to, psychosis, suicidal ideations, or major depression. Patients with mild to moderate depression in the past and no prior history of suicidal gestures or attempts may be enrolled if, in the Investigator’s opinion, they are suitable for treatment;
- Serious, concomitant medical disorder, including active systemic infection and proven or suspected immunosuppressive disorder;
- History of immunodeficiency or autoimmune disease including autoimmune hepatitis, allogenic transplant, or pre-existing autoimmune or antibody-mediated disease including, but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren’s syndrome, or autoimmune thrombocytopenia;
- Administration of any vaccine or immunoglobulin within 30 days before the first dose of TG4040 /SOC;
- Significant cardiovascular disease (e.g., New York Heart Association [NYHA] class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias);
- Systemic corticosteroid therapy or other immunosuppressive/immunomodulating drugs (e.g. Cyclosporine) within 2 months prior to first TG4040/SOC administration; corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are allowed;
- Any known allergy to interferon (IFN), RBV and/or their excipients;
- Any medical contraindications to IFN and/or RBV;
- Any known allergy to gentamycin, to bovine serum albumin, to eggs;
- Women who are breastfeeding;
- Participation in another experimental therapeutic protocol within 6 months prior to baseline and during the study period;
- Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study;
- Patient unable or unwilling to comply with the protocol requirements.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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