Efficacy of the Therapeutic Vaccine TG4040 Combined With Pegylated Interferon and Ribavirin in Chronic HCV Patients (HCVac)

August 9, 2013 updated by: Transgene

A Phase II Randomized, Multicenter, Open-label Study of TG4040 (MVA-HCV) in Combination With Pegylated Interferon Alfa-2a and Ribavirin Versus Pegylated Interferon Alfa-2a and Ribavirin in Treatment-naïve Patients With Chronic Genotype 1 Hepatitis C.

The primary objective of this protocol is to study the effect of the standard of care in hepatitis C (pegylated interferon and ribavirin) associated with therapeutic vaccine TG4040 on the viral load of treatment-naïve patients with chronic genotype 1 hepatitis C infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany
        • Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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); 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);

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 arterial 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 eggs;
  • Women who are breastfeeding;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm A
Standard of care (SOC)
Drug: pegylated interferon and ribavirin
48 weeks
Experimental: Arm B
Vaccine and Standard of care
Biological: TG4040 + SOC
6 injections
Biological: TG4040 + SOC
13 injections
Experimental: Arm C
vaccine and standard of care
Biological: TG4040 + SOC
6 injections
Biological: TG4040 + SOC
13 injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
complete early virologic response
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transgene

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

January 21, 2010

First Submitted That Met QC Criteria

January 25, 2010

First Posted (Estimate)

January 26, 2010

Study Record Updates

Last Update Posted (Estimate)

August 13, 2013

Last Update Submitted That Met QC Criteria

August 9, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG4040.02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Hepatitis C Infection

Clinical Trials on pegylated interferon and ribavirin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe