A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With and Without Ribavirin (Copegus®) in Subjects with Hepatitis C - Phase2 Study of VX-950,Pegasys(peginterferon alfa-2a,Peg-IFN) & Copegus(ribavirin,RBV) in HepatitisC

• Conditions: Hepatitis C virus (HCV) infection; MedDRA version: 8.1Level: LLTClassification code 10019744Term: Hepatitis C

• Registration Number: EUCTR2006-000828-14-AT
• Lead Sponsor: Vertex Pharmaceuticals Incorporated

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

- Male and female subjects, 18-65 years of age, inclusive.
- Genotype 1 (confirmed by standard testing), chronic hepatitis C, confirmed by detectable plasma HCV RNA.
- Judged to be in good health on the basis of medical history and physical examination (including vital signs and ECG), with any chronic medical conditions under stable medical control.
- Both Screening Visit 1 and Screening Visit 2 laboratory values must be within protocl-specified laboratory reference ranges.
- Must agree to use 2 methods of contraception that are highly effective, one barrier method (condom or diaphragm with spermicidal jelly) with a second method such as oral contraceptives, hormonal implant, injectable contraceptive, an intrauterine device or surgical sterilization (i.e. vasectomy or female surgical sterilization), during and for 24 weeks after the last dose of study medication (unless the subject is a woman of documented non-child-bearing potential). Female subjects and female partners of male subjects must use the same precautions. Male subjects must not father a child while on study, and for 24 weeks after the last dose of the study medications.
- Female subjects must have a negative pregnancy test at all visits (screening and pre-dose Day 1) before the first dose of study drugs.
- Willing to refrain from the concomitant use of any medications, substances or foods noted in Section 12.8 of the protocol.
- Willing to initiate SOC (Peg-IFN and RBV) off-study at the conclusion of study drug dosing, if subjects have detectable virus or relapse.
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

- Received any approved or investigational drug or drug regimen for the treatment of hepatitis C.
- Any medical contraindications to Peg-IFN or RBV therapy.
- Decompensated liver disease as shown by screening laboratory results.
- Any other cause of significant liver disease in addition to hepatitis C.
- Diagnosed or suspected hepatocellular carcinoma.
- Histologic evidence of hepatic cirrhosis on any liver biopsy. Most recent liver biopsy must be within 2 years before Study Day 1.
- Alcohol abuse or excessive use (in the opinion of the investigator, as judged by medical history) in the last 12 months.
- Hypersensitivity to tartrazine (yellow dye #5).
- Men whose female partners are pregnant.

Study & Design

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