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OpenTrials
Completed

NCT Number: NCT00336479

Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C

Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fundacion de Investigacion de Diego, Santurce, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
  • Have been infected with hepatitis C virus for greater than (>) 6 months
  • Seronegative for hepatitis B surface antigen and Human Immunodeficiency Virus 1 and 2
  • Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
  • Female subjects must have a negative pregnancy test at all visits before the first dose

Exclusion criteria

  • Received any approved or investigational drug or drug regimen for the treatment of hepatitis C
  • Any medical contraindications to Pegylated Interferon Alfa 2a or Ribavirin therapy
  • 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
  • Diagnosed or suspected hepatocellular carcinoma
  • Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start
  • Alcohol abuse or excessive use in the last 12 months
  • Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)

Treatment and study plan

Telaprevir

Drug

tablet

Other names: VX-950

Ribavirin

Drug

tablet

Other names: RBV

Pegylated Interferon Alfa 2a

Drug

Solution for injection

Other names: Peg-IFN-alfa-2a

Placebo

Other

matching placebo tablet

Primary outcomes

  1. Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing

    Time frame: 24 weeks after the completion of study drug dosing (up to Week 72)

    The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

Secondary outcomes

  1. Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing

    Time frame: 12 weeks after the completion of study drug dosing (up to Week 60)

    The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

  2. Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline up to Week 48

    AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.

  3. Number of Subjects With Viral Relapse

    Time frame: After last dose of study drug up to antiviral follow-up (up to Week 72)

    Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).

  4. Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir

    Time frame: Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85

    Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Received Prior Treatment

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jun 13, 2006
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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