A Phase IIb, randomized, double-blind, placebo-controlled trial to investigate the efficacy, tolerability, safety and pharmacokinetics of TMC435 as part of a treatment regimen including peginterferon alfa-2a and ribavirin in treatment-naïve genotype 1 hepatitis C-infected subjects.
- Conditions
- MedDRA version: 9.1Level: LLTClassification code 10019751Term: Hepatitis C virusHepatitis C virus (HCV)
- Registration Number
- EUCTR2008-007147-13-FR
- Lead Sponsor
- Tibotec Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
Subjects who meet all of the following criteria are eligible for this trial:
1. Male or female subject aged between 18 and 70 years, extremes included;
2. Subject with documented chronic hepatitis C infection, diagnosed by a liver biopsy within 2 years prior to screening that demonstrates evidence of chronic viral hepatitis, and anti- HCV antibody with documented HCV RNA presence by a sensitive and specific assay for at least 6 months in duration.
Note: If no liver biopsy was performed within 2 years prior to screening, this may be done on a separate day during the screening period;
3. Subject with genotype-1 HCV infection;
4. Subjects with plasma HCV RNA of > 100,000 IU/mL at screening (as assessed by standard quantitative in vitro nucleic acid amplification assay);
Note: Retesting of HCV RNA to reassess eligibility will be allowed only once using an unscheduled visit during the screening period.
5. Subject is not receiving and has never received any approved or investigational treatment for chronic HCV infection;
Note: prior HCV treatment with herbal products or nutritional elements is allowed but should be stopped at screening.
6. Body weight between 40 and 125 kg;
7. Subject (male with partner of childbearing potential or female of childbearing potential) agrees to use 2 effective methods of contraception (one of the methods needs to be a barrier method, e.g., condom or diaphragm) from screening throughout the duration of study treatment and for 7 months after the last dose of RBV, or is non-heterosexually active, or is vasectomized (male subject) or has a vasectomized partner (female subjects), or is a female (subject or partner of male subject) of non-childbearing potential;
8. Informed consent form signed voluntarily before the first trial-related activity;
9. Subject being able to comply with the protocol requirements.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Subjects meeting one or more of the following criteria cannot be selected:
1. Cirrhosis confirmed by biopsy taken within 2 years prior to enrollment;
2. Decompensated liver disease defined as history or presence of ascites, hepatic encephalopathy, bleeding esophageal, gastric varices, or laboratory evidence of significantly decreased hepatic function or decompensation (i.e., International Normalized Ratio [INR] > 1.5, or albumin < 30 g/L, or bilirubin > 1.8 x ULN);
3. Any other cause of liver disease of non-HCV etiology. This may include but is not limited to hepatitis A or B, drug- or alcohol-related liver disease, autoimmune hepatitis, hemochromatosis, Wilson’s disease, non-alcoholic steatohepatitis, or primary biliary cirrhosis.
4. Infection/co-infection with non-genotype 1 HCV;
5. Co-infection with human immunodeficiency virus type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test), or hepatitis B virus infection (hepatitis B surface antigen [HBsAg]);
6. History of invasive malignancy diagnosed or treated within 5 years prior to screening (locally treated non-invasive basal cell skin carcinoma is permitted; cervical carcinoma in situ is allowed if treated prior to screening);
7. Evidence of hepatocellular carcinoma (e.g., alpha-fetoprotein [AFP] > 50 ng/mL);
8. Medical conditions which are exclusion criteria for PegIFNa-2a or RBV treatment (please see protocol for details);
9. Any active clinically significant disease other than hepatitis C (e.g., chronic pancreatitis) or findings during screening of medical history or physical examination that, in the investigator’s opinion, would compromise the subject’s safety or the outcome of the trial;
10. Subject with organ transplant (other than cornea or hair transplant or skin graft);
11. Subject with any of the following laboratory abnormalities:
- AST and/or ALT > 10 x upper limit of laboratory normal range (ULN);
- Laboratory abnormalities which are exclusion criteria for PegIFNa-2a or RBV treatment (please refer to the manufacturer’s prescribing information for details):
• Platelet count < 90,000/mm3;
• Absolute neutrophil count < 1500 cells/mm3;
• Hemoglobin < 12 g/dL for females and < 13 g/dL for males;
- Any other grade 3 or grade 4 laboratory abnormality according to the WHO Toxicity Grading Scale.
12. History or evidence of current use of alcohol, barbiturate, amphetamine, recreational or narcotic drug use, which in the investigator’s opinion would compromise the subject’s safety and/or compliance with the trial procedures (period of non-drug/alcohol misuse must be at least be 1 year before the first administration of study medication);
13. Pregnant, planning on becoming pregnant, or breast feeding female subject or male subject whose partner is pregnant or planning on becoming pregnant;
14. Concurrent participation in a clinical trial with another investigational drug or device within 30 days of the screening visit;
15. Known allergy or hypersensitivity to any of the components of the investigational medication or to any of the components of PegIFNa-2a s.c. solution or RBV tablets.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method