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

This study has been completed.
Sponsor:
Information provided by:
Transgene
ClinicalTrials.gov Identifier:
NCT01055821
First received: January 21, 2010
Last updated: August 9, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Chronic Hepatitis C Infection
Drug: pegylated interferon and ribavirin
Biological: TG4040 + SOC
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Transgene:

Primary Outcome Measures:
  • complete early virologic response [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: May 2010
Study Completion Date: August 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Arm C
vaccine and standard of care
Biological: TG4040 + SOC
13 injections

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055821

Locations
Germany
Hospital
Hannover, Germany
Sponsors and Collaborators
Transgene
  More Information

No publications provided

Responsible Party: G Honnet, Transgene
ClinicalTrials.gov Identifier: NCT01055821     History of Changes
Other Study ID Numbers: TG4040.02
Study First Received: January 21, 2010
Last Updated: August 9, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Transgene:
Hepatitis C
Vaccine
HCVac
MVA-HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferons
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014