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A Study of TMC435 in Combination With Pegylated Interferon Alp\Fa-2a and Ribavirin in Patients Infected With Genotype 1 Hepatitis C Virus Who Never Received Treatment

Information source: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C

Intervention: TMC435 (Drug); Ribavirin (R) (Drug); PegIFNα-2a (P) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Tibotec Pharmaceuticals, Ireland

Official(s) and/or principal investigator(s):
Tibotec Pharmaceuticals, Ireland Clinical Trial, Study Director, Affiliation: Tibotec Pharmaceuticals, Ireland

Summary

The purpose of this study is to evaluate the efficacy of 4 different regimens of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV), defined as the proportion of patients with sustained virologic response at Week 72 (patients with undetectable plasma HCV RNA [less than 25 IU per mL undetectable] at the end of treatment and at Week 72), compared to the control group receiving PegIFN and RBV in combination with TMC435-matched placebo.

Clinical Details

Official title: 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-Naive Genotype 1 Hepatitis C-Infected Subjects

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72)

Secondary outcome:

The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Undetectable During Treatment and Follow-up

The Percentage of Participants Who Achieved Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Less Than 25 IU/mL Detectable or Undetectable During Treatment and Follow-up

The Percentage of Participants Achieving Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels of Greater Than or Equal to 2 log10 Drop During Treatment

The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24)

The Percentage of Participants Achieving a Rapid Virologic Response (RVR)

The Percentage of Participants Achieving an Early Virologic Response (EVR)

The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)

The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)

Number of Participants With Viral Breakthrough

The Number of Participants With Viral Relapse

The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normalized ALT Levels at the End of Treatment (EOT)

Plasma Concentrations of TMC435

Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435

Detailed description: This is a randomized (study medication assigned by chance), 5-arm, double-blind (neither investigator nor the participant knows the treatment that the participant receives), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study) study to compare the efficacy, tolerability and safety of different TMC435 regimens combined with peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) versus PegIFNα-2a plus RBV alone in adult treatment-naive patients with chronic genotype 1 HCV infection. The study mainly consists of 3 phases: screening phase (approximately 6 weeks), treatment phase (up to 48 weeks), and follow up phase (up to 48 weeks). In the treatment phase, patients will be divided in to 5 different arms in a 1: 1:1: 1:1 randomized ratio. In treatment arms 1 and 2, patients will receive 12 weeks of therapy with TMC435 along with PegIFNα 2a and RBV followed by treatment with PegIFNα 2a, RBV, and TMC435-matched placebo. In treatment arms 3 and 4, patients will receive 24 weeks of therapy with TMC435, PegIFNα 2a, and RBV. In treatment arm 5 (control group), patients will receive PegIFNα 2a and RBV for 48 weeks and TMC435 matched placebo for the first 24 weeks. Collection of blood samples for efficacy evaluations will be done at scheduled visits throughout the study. Safety evaluations for adverse events, clinical laboratory tests, physical examination, vital signs and electrocardiogram will be monitored throughout the study. The total duration of the study will be up to approximately 72 weeks after initiation of treatment.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with documented chronic genotype-1 hepatitis C infection and with plasma HCV

RNA of > 100,000 IU/mL at screening

- Patients that have not been treated before for HCV

- Patients that are of childbearing potential or have a partner of childbearing

potential should agree to use 2 effective methods of contraception Exclusion Criteria:

- Patients with cirrhosis or evidence of hepatic decompensation

- Co-infection with the human immunodeficiency virus (HIV)

- Any contraindication to Pegasys or Copegus therapy

- History of, or any current medical condition which could impact the safety of the

patient in the study

Locations and Contacts

Concord, Australia

Darlinghurst, Australia

Fitzroy, Australia

Melbourne, Australia

Sydney, Australia

Woolloongabba N/A, Australia

Wien, Austria

Brugge, Belgium

Brussels, Belgium

Bruxelles, Belgium

Edegem, Belgium

Gent, Belgium

Leuven, Belgium

Roeselare, Belgium

Aarhus, Denmark

Copenhagen, Denmark

Hvidovre N/A, Denmark

Kolding, Denmark

Odense N/A, Denmark

Clichy, France

Creteil N/A, France

Grenoble, France

Lyon, France

Nice, France

Paris, France

Vandoeuvre Les Nancy, France

Berlin, Germany

Düsseldorf, Germany

Frankfurt A. M., Germany

Freiburg, Germany

Hamburg, Germany

Hannover, Germany

Köln, Germany

Stuttgart, Germany

Würzburg, Germany

Auckland, New Zealand

Christchurch, New Zealand

Hamilton, New Zealand

Bergen, Norway

Nordbyhagen, Norway

Oslo, Norway

Tromsø, Norway

Bialystok, Poland

Bydgoszcz, Poland

Czeladz, Poland

Kielce, Poland

Lodz, Poland

Warschau, Poland

Moscow, Russian Federation

Nizhny Novgorod, Russian Federation

Saint-Petersburg, Russian Federation

Samara, Russian Federation

Smolensk, Russian Federation

St Petersburg, Russian Federation

Barcelona, Spain

Madrid, Spain

Sevilla N/A, Spain

Valencia, Spain

Calgary, Alberta, Canada

Los Angeles, California, United States

Jacksonville, Florida, United States

Orlando, Florida, United States

Palm Harbor, Florida, United States

Chicago, Illinois, United States

New Orleans, Louisiana, United States

Saint Paul, Minnesota, United States

New York, New York, United States

Chapel Hill, North Carolina, United States

Cincinnati, Ohio, United States

Toronto, Ontario, Canada

Montreal, Quebec, Canada

Germantown, Tennessee, United States

Charlottesville, Virginia, United States

Additional Information

Starting date: June 2009
Last updated: May 19, 2014

Page last updated: August 23, 2015

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