A Phase IIa randomized, open-label study of telaprevir (VX-950) administered every 12 or every 8 hours in combination with either Peg-IFN alfa2a (Pegasys®) and ribavirin (Copegus®) or Peg-IFN alfa2b (PegIntron®) and ribavirin (Rebetol®) in treatment naïve subjects with chronic genytype 1 hepatitis C infection.Ensayo fase IIa, aleatorizado, abierto de telaprevir (VX-950) administrado cada 12 o cada 8 horas en combinación, bien con Peg-IFN alfa2a (Pegasys (R)) y ribavirina (Copegus (R)) o Peg-IFN alfa2b (PegIntron(R)) y ribavirina (Rebetol(R)) en el tratamiento de sujetos con infección crónica de Hepatitis C genotipo 1 que no han sido previamente tratados

• Conditions: Hepatitis C infection; MedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

• Registration Number: EUCTR2007-001044-44-ES
• Lead Sponsor: Tibotec BVBA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-11
• Last Update Posted: 18 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Subjects who meet all of the following criteria are eligible for this trial.
1. Male and female subjects 18-65 years of age.
2. Genotype 1 chronic hepatitis C infection. Chronic (non-acute) disease status must be confirmed by at least 1 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
hepatitis C is met), or
- diagnosis of hepatitis C > 6 months before the screening period.
3. Naïve of therapy for HCV (including investigational products).
4. Screening laboratory values of the following variables must meet the acceptable values defined below:
Laboratory variable Acceptable values
Absolute neutrophil count = 1,500/cm³
Platelet count = 100,000/cm³
Bilirubin Within normal range (except for subjects with
Gilbert’s Syndrome)
All other hematology and clinical chemistry must be within normal limits or show no
clinically significant abnormalities, in the opinion of the investigator.
5. Detectable plasma HCV RNA > 10,000 IU/mL at entry.
6. Judged to be in otherwise good health, in the opinion of the investigator.
7. Liver biopsy within 3 years of the date of the screening visit.
8. Agree to the use of two methods of contraception if heterosexually active, unless the male partner has undergone a vasectomy (see Section 5.2.4).
9. Willing to refrain from the concomitant use of any medications, substances or foods noted in Section 5.3.10.1.
10. Informed Consent Form (ICF) signed voluntarily before first trial-related activity.
11. Agree not to participate in other clinical studies (with the exception of observational studies) for the duration of his/her participation in this trial.

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

Exclusion Criteria

Subjects meeting one or more of the following criteria cannot be selected.
1. Presence of a concomitant medical condition that in the opinion of the investigator could influence the results of the study or that could represent an additional risk for the administration of the study medication to the subject.
2. Any medical contraindications to Peg-IFN alfa2a, Peg-IFN alfa2b, or RBV therapy
including the following:
- abnormal thyroid stimulating hormone (TSH) levels (except if well-controlled on
medication) or poorly controlled thyroid function;
- evidence of clinically significant cardiac dysfunction;
- history of psychiatric disorders determined by the investigator to contra-indicate the use of IFN-based therapy;
- antinuclear antibody (ANA) titer = 1:320;
- history of hemoglobinopathies.
3. History or evidence of decompensated liver disease defined as a prior or current history of ascites, hepatic encephalopathy, bleeding esophageal or gastric varices.
4. Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson’s disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis.
5. Diagnosed or suspected hepatocellular carcinoma. Alfa-fetoprotein at screening must be less than 50 ng/mL, or if higher, absence of a mass on an ultrasound.
6. 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 and/or compliance with study procedures.
7. Human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection.
8. Women who are pregnant, planning on becoming pregnant, or breast feeding, and partners of women who are pregnant or breast feeding.
9. Hypersensitivity to tartrazine.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: ;Primary end point(s): Plasma Hepatitis C Virus RNA level;Main Objective: The objective of this trial is to explore the efficacy, safety, tolerability, pharmacokinetics and pharmacokinetic-pharmacodynamic relationships of telaprevir when administered as 750 mg q8h or 1125 mg q12h in combination with pegylated interferon alfa 2a (Pegasys) and ribavirin (Copegus) or pegylated interferon alfa2b (PegIntron) and ribavirin (Rebetol)