A Phase IIa randomized, partially blinded trial of telaprevir (VX-950) in treatment-naïve subjects with chronic genotype 2 or 3 hepatitis C infectio
- Conditions
- Hepatitis C infectionMedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C
- Registration Number
- EUCTR2007-002920-14-FR
- Lead Sponsor
- Tibotec BVBA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1. Male and female subjects, 18-65 years of age, inclusive.
2. Subjects chronically infected with either
a) genotype 2 HCV with HCV RNA > 10,000 IU/mL, or
b) genotype 3 HCV with HCV RNA >10,000 IU/mL.
Chronic disease status must be confirmed by at least one of the following standard criteria:
- history of a remote risk factor (e.g., intravenous drug abuse or blood transfusion), or abnormal alanine aminotransferase (ALT) levels for > 6 months prior to screening
'Note': elevated ALT is not an inclusion criterion if one of the other criteria for chronic
HCV infection is met, or
- diagnosis of hepatitis C > 6 months before the screening period.
3. Subject has never received treatment for HCV (including investigational products).
4. Screening laboratory values of the following variables must meet the acceptable values defined below:
Absolute neutrophil count:>=1,500/mm3
Platelet count: >= 100,000/mm3
Hemoglobin: within normal range
All other hematology and biochemistry results must show no clinically significant abnormalities in the opinion of the investigator.
5. Subjects judged to be in good health, in the opinion of the investigator, on the basis of medical history and physical examination (including vital signs and screening ECG), with any chronic medical conditions under stable medical control.
6. Subjects must agree to the use of two effective methods of contraception as outlined in Section 5.2.4, if heterosexually active, unless the male subject/partner has undergone a vasectomy or if the female subjectlpartner has had a bilateral oophorectomy, or a total hysterectomy, or if she is post-menopausal for at least two years.
7. Subject is willing to refrain from the concomitant use of any medications or substances noted in Section 5.3.11.
8. Subject has signed ICF voluntarily before the first trial-related activity.
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) no
F.1.3.1 Number of subjects for this age range
1. Subject has a concomitant medical condition that in the opinion of the investigator could influence the results of the trial or that could represent an additional risk for the administration of the study medication to the subject.
2. Subject has medical contraindications to the administration of an interferon (Peg-IFN alfa2a in particular) or REW treatment, including but not limited to the following:
- abnormal thyroid stimulating hormone (TSH) levels or poorly controlled thyroid
function;
- evidence of clinically significant cardiac dysfunction;
- history of psychiatric disorders determined by the investigator to contraindicate the use of IFN-based therapy;
- ANA titer>= 1:320;
- history of hemoglobinopathies.
3. Subject has history or evidence of cirrhosis, end-stage or decompensated liver disease, or hepatocellular carcinoma as shown by screening laboratory results of any of the following:
a. international normalized ratio (INR) >= 1.7;
b. serum albumin < 3.5 g/dL;
c. serum total bilirubin > 1.8 times the upper limit of normal (ULN), unless isolated and for subjects with Gilbert's Syndrome;
d. history of ascitis, hepatic encephalopathy, bleeding esophageal varices;
e. AFP > 50 ng/mL.
4. Subject has history or suspicion of alcohol, barbiturate, or amphetamine recreational or narcotic drug use, which in the investigator's opinion would compromise the subject's safety andlor compliance with study procedures.
5. Subject has HIV or HBV co-infection.
6. Women who are pregnant, planning to become pregnant, or breastfeeding, and partners of women who are pregnant or breastfeeding.
7. Subject has hypersensitivity to tartrazine.
8. Subject participated in any clinical trial for an investigational drug within 90 days before drug administration or participated in more than 2 drug studies in the last 12 months.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: - to assess the effect of telaprevir on genotype 2 and 3 HCV early viral kinetics, when<br>administered over 2 weeks, alone or in combination with Peg-IFN alfa2a and REV,<br>- to evaluate the single-dose and steady-state pharmacokinetics of telaprevir and<br>VRT-127394, and the pharmacokinetic/pharmacodynamic relationship of telaprevir in<br>subjects chronically infected with genotype 2 or 3 HCV;<br>- to assess and characterize pheno- and genotypically resistant variants potentially arising after 2 weeks of telaprevir treatment with or without Peg-IFN alfa2a and RBV, in subjects chronically infected with genotype 2 or 3 HCV;<br>- to evaluate the safety and tolerability of 2-week treatment with telaprevir with or without Peg-IFN alfa2a and RBV in subjects chronically infected with genotype 2 or 3 HCV.;Secondary Objective: ;Primary end point(s): Plasma hepatitis C virus RNA level.
- Secondary Outcome Measures
Name Time Method